Trial Outcomes & Findings for Passive Immunity Trial for Our Nation to Treat COVID-19 in Hospitalized Adults (NCT NCT04362176)
NCT ID: NCT04362176
Last Updated: 2022-11-03
Results Overview
Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows: 1. Not hospitalized with resumption of normal activities. 2. Not hospitalized, but unable to resume normal activities. 3. Hospitalized, not on supplemental oxygen. 4. Hospitalized, on supplemental oxygen. 5. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both 6. Hospitalized, on ECMO, invasive mechanical ventilation, or both. 7. Death
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
974 participants
Primary outcome timeframe
Study Day 15
Results posted on
2022-11-03
Participant Flow
Participant milestones
| Measure |
Pathogen Reduced SARS-CoV-2 Convalescent Plasma
Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.
pathogen reduced SARS-CoV-2 convalescent plasma: Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
|
Placebo
Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.
Placebo: Lactated Ringer's solution with multivitamins
|
|---|---|---|
|
Overall Study
STARTED
|
495
|
479
|
|
Overall Study
COMPLETED
|
482
|
465
|
|
Overall Study
NOT COMPLETED
|
13
|
14
|
Reasons for withdrawal
| Measure |
Pathogen Reduced SARS-CoV-2 Convalescent Plasma
Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.
pathogen reduced SARS-CoV-2 convalescent plasma: Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
|
Placebo
Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.
Placebo: Lactated Ringer's solution with multivitamins
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
8
|
|
Overall Study
Withdrawn (Participant/PI withdrew consent)
|
8
|
6
|
Baseline Characteristics
Final analysis only included 960 participants. The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
Baseline characteristics by cohort
| Measure |
Pathogen Reduced SARS-CoV-2 Convalescent Plasma
n=487 Participants
Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.
pathogen reduced SARS-CoV-2 convalescent plasma: Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
|
Placebo
n=473 Participants
Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.
Placebo: Lactated Ringer's solution with multivitamins
|
Total
n=960 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants • Final analysis only included 960 participants. The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
0 Participants
n=107 Participants • Final analysis only included 960 participants. The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
0 Participants
n=206 Participants • Final analysis only included 960 participants. The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
|
Age, Categorical
Between 18 and 65 years
|
296 Participants
n=99 Participants • Final analysis only included 960 participants. The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
301 Participants
n=107 Participants • Final analysis only included 960 participants. The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
597 Participants
n=206 Participants • Final analysis only included 960 participants. The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
|
Age, Categorical
>=65 years
|
191 Participants
n=99 Participants • Final analysis only included 960 participants. The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
172 Participants
n=107 Participants • Final analysis only included 960 participants. The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
363 Participants
n=206 Participants • Final analysis only included 960 participants. The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
|
Sex: Female, Male
Female
|
206 Participants
n=99 Participants
|
204 Participants
n=107 Participants
|
410 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
281 Participants
n=99 Participants
|
269 Participants
n=107 Participants
|
550 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
72 Participants
n=99 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
71 Participants
n=107 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
143 Participants
n=206 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
406 Participants
n=99 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
396 Participants
n=107 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
802 Participants
n=206 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=99 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
6 Participants
n=107 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
15 Participants
n=206 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=99 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
5 Participants
n=107 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
11 Participants
n=206 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=99 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
11 Participants
n=107 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
25 Participants
n=206 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=99 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
4 Participants
n=107 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
6 Participants
n=206 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
|
Race (NIH/OMB)
Black or African American
|
104 Participants
n=99 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
80 Participants
n=107 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
184 Participants
n=206 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
|
Race (NIH/OMB)
White
|
272 Participants
n=99 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
285 Participants
n=107 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
557 Participants
n=206 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=99 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
11 Participants
n=107 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
19 Participants
n=206 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
81 Participants
n=99 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
77 Participants
n=107 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
158 Participants
n=206 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
|
Region of Enrollment
United States
|
487 participants
n=99 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
473 participants
n=107 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
960 participants
n=206 Participants • The 14 patients not included in the analysis all withdrew their consent following randomization which removes them from the primary analytical population.
|
PRIMARY outcome
Timeframe: Study Day 15Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows: 1. Not hospitalized with resumption of normal activities. 2. Not hospitalized, but unable to resume normal activities. 3. Hospitalized, not on supplemental oxygen. 4. Hospitalized, on supplemental oxygen. 5. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both 6. Hospitalized, on ECMO, invasive mechanical ventilation, or both. 7. Death
Outcome measures
| Measure |
Pathogen Reduced SARS-CoV-2 Convalescent Plasma
n=487 Participants
Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.
pathogen reduced SARS-CoV-2 convalescent plasma: Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
|
Placebo
n=473 Participants
Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.
Placebo: Lactated Ringer's solution with multivitamins
|
|---|---|---|
|
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score
1: not hospitalized with resumption of normal pre-illness activities
|
150 Participants
|
144 Participants
|
|
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score
2: not hospitalized but unable to resume normal pre-illness activities
|
157 Participants
|
167 Participants
|
|
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score
3: hospitalized and not on supplemental oxygen
|
16 Participants
|
11 Participants
|
|
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score
4: hospitalized and on standard flow oxygen
|
42 Participants
|
39 Participants
|
|
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score
5: hospitalized and on nasal high flow oxygen therapy or non-invasive ventilation
|
16 Participants
|
15 Participants
|
|
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score
6: hospitalized and on invasive mechanical ventilation or ECMO
|
43 Participants
|
49 Participants
|
|
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score
7: death
|
63 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Baseline to Study Day 14Population: The participant flow table, lists the 947 that are not lost to follow-up. This matches the N for day 14 and day 28 mortality. While the primary endpoint can be calculated from the "not withdrawn" population, the mortality endpoints come from the "not lost-to-follow-up" population.
All-location, all-cause 14-day mortality; mortality was assessed via EHR review, phone call, social media review
Outcome measures
| Measure |
Pathogen Reduced SARS-CoV-2 Convalescent Plasma
n=482 Participants
Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.
pathogen reduced SARS-CoV-2 convalescent plasma: Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
|
Placebo
n=465 Participants
Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.
Placebo: Lactated Ringer's solution with multivitamins
|
|---|---|---|
|
All-location, All-cause 14-day Mortality
|
63 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Baseline to Study Day 28Population: The participant flow table, lists the 947 that are not lost to follow-up. This matches the N for day 14 and day 28 mortality. While the primary endpoint can be calculated from the "not withdrawn" population, the mortality endpoints come from the "not lost-to-follow-up" population.
All-location, all-cause 28-day mortality
Outcome measures
| Measure |
Pathogen Reduced SARS-CoV-2 Convalescent Plasma
n=482 Participants
Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.
pathogen reduced SARS-CoV-2 convalescent plasma: Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
|
Placebo
n=465 Participants
Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.
Placebo: Lactated Ringer's solution with multivitamins
|
|---|---|---|
|
All-location, All-cause 28-day Mortality
|
89 Participants
|
80 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 28 (assessed on Study Day 29)Population: The participant flow table, lists the 947 that are not lost to follow-up. Analysis includes 482 in the Convalescent Plasma arm and 465 in the Placebo arm. This matches the N for day 14 and day 28 mortality. While the primary endpoint can be calculated from the "not withdrawn" population, the mortality endpoints come from the "not lost-to-follow-up" population.
Number of participants survived through Day 28
Outcome measures
| Measure |
Pathogen Reduced SARS-CoV-2 Convalescent Plasma
n=482 Participants
Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.
pathogen reduced SARS-CoV-2 convalescent plasma: Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
|
Placebo
n=465 Participants
Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.
Placebo: Lactated Ringer's solution with multivitamins
|
|---|---|---|
|
Survival Through 28 Days
|
393 Participants
|
385 Participants
|
SECONDARY outcome
Timeframe: Baseline to Study Day 3Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows: 1. Not hospitalized with resumption of normal activities. 2. Not hospitalized, but unable to resume normal activities. 3. Hospitalized, not on supplemental oxygen. 4. Hospitalized, on supplemental oxygen. 5. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both 6. Hospitalized, on ECMO, invasive mechanical ventilation, or both. 7. Death
Outcome measures
| Measure |
Pathogen Reduced SARS-CoV-2 Convalescent Plasma
n=487 Participants
Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.
pathogen reduced SARS-CoV-2 convalescent plasma: Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
|
Placebo
n=473 Participants
Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.
Placebo: Lactated Ringer's solution with multivitamins
|
|---|---|---|
|
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3
1: not hospitalized with resumption of normal pre-illness activities
|
1 Participants
|
6 Participants
|
|
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3
2: not hospitalized but unable to resume normal pre-illness activities
|
49 Participants
|
54 Participants
|
|
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3
3: hospitalized and not on supplemental oxygen
|
42 Participants
|
49 Participants
|
|
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3
4: hospitalized and on standard flow oxygen
|
201 Participants
|
184 Participants
|
|
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3
5: hospitalized and on nasal high flow oxygen therapy or non-invasive ventilation
|
110 Participants
|
113 Participants
|
|
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3
6: hospitalized and on invasive mechanical ventilation or ECMO
|
74 Participants
|
63 Participants
|
|
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3
7: death
|
10 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Study Day 8Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows: 1. Not hospitalized with resumption of normal activities. 2. Not hospitalized, but unable to resume normal activities. 3. Hospitalized, not on supplemental oxygen. 4. Hospitalized, on supplemental oxygen. 5. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both 6. Hospitalized, on ECMO, invasive mechanical ventilation, or both. 7. Death
Outcome measures
| Measure |
Pathogen Reduced SARS-CoV-2 Convalescent Plasma
n=487 Participants
Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.
pathogen reduced SARS-CoV-2 convalescent plasma: Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
|
Placebo
n=473 Participants
Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.
Placebo: Lactated Ringer's solution with multivitamins
|
|---|---|---|
|
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8
1: not hospitalized with resumption of normal pre-illness activities
|
95 Participants
|
110 Participants
|
|
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8
2: not hospitalized but unable to resume normal pre-illness activities
|
130 Participants
|
125 Participants
|
|
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8
3: hospitalized and not on supplemental oxygen
|
31 Participants
|
16 Participants
|
|
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8
4: hospitalized and on standard flow oxygen
|
77 Participants
|
78 Participants
|
|
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8
5: hospitalized and on nasal high flow oxygen therapy or non-invasive ventilation
|
58 Participants
|
60 Participants
|
|
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8
6: hospitalized and on invasive mechanical ventilation or ECMO
|
64 Participants
|
62 Participants
|
|
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8
7: death
|
32 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Study Day 29Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows: 1. Not hospitalized with resumption of normal activities. 2. Not hospitalized, but unable to resume normal activities. 3. Hospitalized, not on supplemental oxygen. 4. Hospitalized, on supplemental oxygen. 5. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both 6. Hospitalized, on ECMO, invasive mechanical ventilation, or both. 7. Death
Outcome measures
| Measure |
Pathogen Reduced SARS-CoV-2 Convalescent Plasma
n=487 Participants
Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.
pathogen reduced SARS-CoV-2 convalescent plasma: Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
|
Placebo
n=473 Participants
Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.
Placebo: Lactated Ringer's solution with multivitamins
|
|---|---|---|
|
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29
1: not hospitalized with resumption of normal pre-illness activities
|
183 Participants
|
204 Participants
|
|
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29
2: not hospitalized but unable to resume normal pre-illness activities
|
168 Participants
|
144 Participants
|
|
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29
3: hospitalized and not on supplemental oxygen
|
7 Participants
|
7 Participants
|
|
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29
4: hospitalized and on standard flow oxygen
|
11 Participants
|
14 Participants
|
|
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29
5: hospitalized and on nasal high flow oxygen therapy or non-invasive ventilation
|
5 Participants
|
4 Participants
|
|
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29
6: hospitalized and on invasive mechanical ventilation or ECMO
|
24 Participants
|
20 Participants
|
|
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29
7: death
|
89 Participants
|
80 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 28Number of days without use of oxygen
Outcome measures
| Measure |
Pathogen Reduced SARS-CoV-2 Convalescent Plasma
n=487 Participants
Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.
pathogen reduced SARS-CoV-2 convalescent plasma: Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
|
Placebo
n=473 Participants
Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.
Placebo: Lactated Ringer's solution with multivitamins
|
|---|---|---|
|
Oxygen-free Days Through Day 28
|
21 Day
Interval 0.0 to 25.0
|
21 Day
Interval 0.0 to 25.0
|
SECONDARY outcome
Timeframe: Baseline to Day 28Number of days without use of a ventilator
Outcome measures
| Measure |
Pathogen Reduced SARS-CoV-2 Convalescent Plasma
n=487 Participants
Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.
pathogen reduced SARS-CoV-2 convalescent plasma: Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
|
Placebo
n=473 Participants
Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.
Placebo: Lactated Ringer's solution with multivitamins
|
|---|---|---|
|
Ventilator-free Days Through Day 28
|
28 Day
Interval 18.0 to 28.0
|
28 Day
Interval 22.0 to 28.0
|
SECONDARY outcome
Timeframe: Baseline to Day 28Number of days without use of vasopressors
Outcome measures
| Measure |
Pathogen Reduced SARS-CoV-2 Convalescent Plasma
n=487 Participants
Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.
pathogen reduced SARS-CoV-2 convalescent plasma: Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
|
Placebo
n=473 Participants
Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.
Placebo: Lactated Ringer's solution with multivitamins
|
|---|---|---|
|
Vasopressor-free Days Through Day 28
|
28 Day
Interval 27.0 to 28.0
|
28 Day
Interval 26.0 to 28.0
|
SECONDARY outcome
Timeframe: Baseline to Day 28Number of days outside of ICU
Outcome measures
| Measure |
Pathogen Reduced SARS-CoV-2 Convalescent Plasma
n=487 Participants
Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.
pathogen reduced SARS-CoV-2 convalescent plasma: Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
|
Placebo
n=473 Participants
Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.
Placebo: Lactated Ringer's solution with multivitamins
|
|---|---|---|
|
ICU-free Days Through Day 28
|
28 Day
Interval 2.0 to 28.0
|
28 Day
Interval 13.0 to 28.0
|
SECONDARY outcome
Timeframe: Baseline to Day 28Number of days outside of the hospital
Outcome measures
| Measure |
Pathogen Reduced SARS-CoV-2 Convalescent Plasma
n=487 Participants
Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.
pathogen reduced SARS-CoV-2 convalescent plasma: Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
|
Placebo
n=473 Participants
Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.
Placebo: Lactated Ringer's solution with multivitamins
|
|---|---|---|
|
Hospital-free Days Through Day 28
|
20 Day
Interval 0.0 to 24.0
|
21 Day
Interval 0.0 to 24.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 28Number of participants with Acute kidney injury
Outcome measures
| Measure |
Pathogen Reduced SARS-CoV-2 Convalescent Plasma
n=487 Participants
Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.
pathogen reduced SARS-CoV-2 convalescent plasma: Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
|
Placebo
n=473 Participants
Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.
Placebo: Lactated Ringer's solution with multivitamins
|
|---|---|---|
|
Acute Kidney Injury
|
2 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 28Number of participants requiring renal replacement therapy
Outcome measures
| Measure |
Pathogen Reduced SARS-CoV-2 Convalescent Plasma
n=487 Participants
Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.
pathogen reduced SARS-CoV-2 convalescent plasma: Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
|
Placebo
n=473 Participants
Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.
Placebo: Lactated Ringer's solution with multivitamins
|
|---|---|---|
|
Renal Replacement Therapy
|
20 Participants
|
15 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 28Number of participants with documented venous thromboembolic disease (DVT or PE)
Outcome measures
| Measure |
Pathogen Reduced SARS-CoV-2 Convalescent Plasma
n=487 Participants
Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.
pathogen reduced SARS-CoV-2 convalescent plasma: Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
|
Placebo
n=473 Participants
Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.
Placebo: Lactated Ringer's solution with multivitamins
|
|---|---|---|
|
Documented Venous Thromboembolic Disease (DVT or PE)
|
101 Participants
|
109 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 28Number of Participants with myocardial infarction or ischemic stroke
Outcome measures
| Measure |
Pathogen Reduced SARS-CoV-2 Convalescent Plasma
n=487 Participants
Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.
pathogen reduced SARS-CoV-2 convalescent plasma: Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
|
Placebo
n=473 Participants
Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.
Placebo: Lactated Ringer's solution with multivitamins
|
|---|---|---|
|
Documented Cardiovascular Event (Myocardial Infarction or Ischemic Stroke)
|
22 Participants
|
18 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 28Number of participants with transfusion reaction (fever/rash)
Outcome measures
| Measure |
Pathogen Reduced SARS-CoV-2 Convalescent Plasma
n=487 Participants
Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.
pathogen reduced SARS-CoV-2 convalescent plasma: Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
|
Placebo
n=473 Participants
Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.
Placebo: Lactated Ringer's solution with multivitamins
|
|---|---|---|
|
Transfusion Reaction
|
6 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 28Number of participants with transfusion related acute lung injury (TRALI)
Outcome measures
| Measure |
Pathogen Reduced SARS-CoV-2 Convalescent Plasma
n=487 Participants
Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.
pathogen reduced SARS-CoV-2 convalescent plasma: Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
|
Placebo
n=473 Participants
Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.
Placebo: Lactated Ringer's solution with multivitamins
|
|---|---|---|
|
Transfusion Related Acute Lung Injury (TRALI)
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 28Number of participants with transfusion associated circulatory overload (TACO)
Outcome measures
| Measure |
Pathogen Reduced SARS-CoV-2 Convalescent Plasma
n=487 Participants
Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.
pathogen reduced SARS-CoV-2 convalescent plasma: Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
|
Placebo
n=473 Participants
Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.
Placebo: Lactated Ringer's solution with multivitamins
|
|---|---|---|
|
Transfusion Associated Circulatory Overload (TACO)
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 28Number of participants with transfusion related infection
Outcome measures
| Measure |
Pathogen Reduced SARS-CoV-2 Convalescent Plasma
n=487 Participants
Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.
pathogen reduced SARS-CoV-2 convalescent plasma: Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
|
Placebo
n=473 Participants
Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.
Placebo: Lactated Ringer's solution with multivitamins
|
|---|---|---|
|
Transfusion Related Infection
|
0 Participants
|
0 Participants
|
Adverse Events
Pathogen Reduced SARS-CoV-2 Convalescent Plasma
Serious events: 21 serious events
Other events: 27 other events
Deaths: 89 deaths
Placebo
Serious events: 16 serious events
Other events: 19 other events
Deaths: 80 deaths
Serious adverse events
| Measure |
Pathogen Reduced SARS-CoV-2 Convalescent Plasma
n=495 participants at risk
Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.
pathogen reduced SARS-CoV-2 convalescent plasma: Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
|
Placebo
n=479 participants at risk
Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.
Placebo: Lactated Ringer's solution with multivitamins
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
acute hypoxemic respiratory failure
|
0.00%
0/495 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.40%
2/495 • Number of events 2 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
0.40%
2/495 • Number of events 2 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 2 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Cardiac disorders
Asystole
|
0.00%
0/495 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/495 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Cardiac disorders
Cardiac arrest
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Cardiac disorders
cardiac disorder, other, pneumopericardium
|
0.00%
0/495 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Gastrointestinal disorders
Colonic perforation
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Nervous system disorders
Guillain-Barre Syndrome Grade 3
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Vascular disorders
Hypotension
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Infections and infestations
Lung Infection
|
0.40%
2/495 • Number of events 2 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
General disorders
Multi-organ failure
|
0.40%
2/495 • Number of events 2 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Cardiac disorders
Myocardial infarction
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Infections and infestations
Peritoneal Infection
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Cardiac disorders
Pulmonary Edema
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.8%
9/495 • Number of events 9 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
1.0%
5/479 • Number of events 5 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Infections and infestations
Sepsis
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.42%
2/479 • Number of events 2 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Blood and lymphatic system disorders
Sepsis
|
0.00%
0/495 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Cardiac disorders
Thromboembolic event
|
0.00%
0/495 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Respiratory, thoracic and mediastinal disorders
Worsening respiratory failure
|
0.00%
0/495 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
Other adverse events
| Measure |
Pathogen Reduced SARS-CoV-2 Convalescent Plasma
n=495 participants at risk
Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.
pathogen reduced SARS-CoV-2 convalescent plasma: Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
|
Placebo
n=479 participants at risk
Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.
Placebo: Lactated Ringer's solution with multivitamins
|
|---|---|---|
|
General disorders
Abdominal pain
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/495 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Renal and urinary disorders
acute kidney injury
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Investigations
Alanine Aminotransferase Increase
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Psychiatric disorders
anxiety
|
0.00%
0/495 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Cardiac disorders
Atrial Fibrillation
|
0.40%
2/495 • Number of events 2 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Infections and infestations
Bacteremia
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Blood and lymphatic system disorders
Bacteremia
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Cardiac disorders
Blurry Vision
|
0.00%
0/495 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Cardiac disorders
Cardiac disorders-Other, irregular heartbeat
|
0.00%
0/495 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Cardiac disorders
cardiac disorders - other (volume overload)
|
0.00%
0/495 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Cardiac disorders
Chest Pain
|
0.61%
3/495 • Number of events 3 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Gastrointestinal disorders
colitis
|
0.00%
0/495 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Gastrointestinal disorders
Colonic Hemorrhage
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Gastrointestinal disorders
constipation
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Respiratory, thoracic and mediastinal disorders
decompensated
|
0.00%
0/495 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/495 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
General disorders
Fever
|
0.40%
2/495 • Number of events 2 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.42%
2/479 • Number of events 2 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Infections and infestations
Fungemia
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Nervous system disorders
Headache
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Metabolism and nutrition disorders
hyperkalemia
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Metabolism and nutrition disorders
hypernatremia
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Cardiac disorders
hypertension
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Injury, poisoning and procedural complications
infusion related reaction
|
0.40%
2/495 • Number of events 2 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
General disorders
Infusion site extravasation
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Musculoskeletal and connective tissue disorders
left hand tightness
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Blood and lymphatic system disorders
leukocytosis
|
0.00%
0/495 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Cardiac disorders
myocardial infarction
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
General disorders
nausea
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Infections and infestations
Pharyngitis
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Chest Pain
|
0.00%
0/495 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.42%
2/479 • Number of events 2 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Pregnancy, puerperium and perinatal conditions
Premature delivery
|
0.00%
0/495 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Gastrointestinal disorders
proctitis
|
0.00%
0/495 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.42%
2/479 • Number of events 2 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Gastrointestinal disorders
Retroperitoneal hemorrhage
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Cardiac disorders
Sinus Bradycardia
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
General disorders
Sore throat
|
0.00%
0/495 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Respiratory, thoracic and mediastinal disorders
subcutaneous emphysema tracks
|
0.00%
0/495 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Vascular disorders
superficial thrombophlebitis
|
0.00%
0/495 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Respiratory, thoracic and mediastinal disorders
tachypnea
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/495 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.21%
1/479 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Respiratory, thoracic and mediastinal disorders
worsening hypoxia
|
0.00%
0/495 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.42%
2/479 • Number of events 2 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
|
Respiratory, thoracic and mediastinal disorders
worsening of acute hypoxic respiratory failure
|
0.20%
1/495 • Number of events 1 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
0.00%
0/479 • Baseline - Day 90
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion
|
Additional Information
Todd Rice, M.D., MSc
Vanderbilt University Medical Center
Phone: 615-343-8010
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place