Trial Outcomes & Findings for COVID-19 Convalescent Plasma for the Treatment of Hospitalized Patients With Pneumonia Caused by SARS-CoV-2. (NCT NCT04397757)
NCT ID: NCT04397757
Last Updated: 2022-04-19
Results Overview
Number of participants with at least one serious adverse events (SAEs) up to Study Day 29.
COMPLETED
PHASE1
80 participants
Up to Study Day 29
2022-04-19
Participant Flow
Participant milestones
| Measure |
COVID-19 Convalescent Plasma
On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care
|
Standard of Care
Standard of care treatment administered only
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
39
|
|
Overall Study
Treated
|
39
|
39
|
|
Overall Study
COMPLETED
|
32
|
25
|
|
Overall Study
NOT COMPLETED
|
9
|
14
|
Reasons for withdrawal
| Measure |
COVID-19 Convalescent Plasma
On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care
|
Standard of Care
Standard of care treatment administered only
|
|---|---|---|
|
Overall Study
Death
|
3
|
11
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
Baseline Characteristics
COVID-19 Convalescent Plasma for the Treatment of Hospitalized Patients With Pneumonia Caused by SARS-CoV-2.
Baseline characteristics by cohort
| Measure |
COVID-19 Convalescent Plasma
n=40 Participants
COVID-19 Convalescent plasma on Study Day 1 in addition to standard care
COVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type
|
Standard of Care
n=39 Participants
Standard care alone
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
40 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
39 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=39 Participants
|
24 Participants
n=41 Participants
|
43 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
36 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=39 Participants
|
37 Participants
n=41 Participants
|
76 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
42 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
30 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=39 Participants
|
39 participants
n=41 Participants
|
80 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Up to Study Day 29Number of participants with at least one serious adverse events (SAEs) up to Study Day 29.
Outcome measures
| Measure |
COVID-19 Convalescent Plasma
n=40 Participants
COVID-19 Convalescent plasma on Study Day 1 in addition to standard care
COVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type
|
Standard of Care
n=39 Participants
Standard care alone
|
|---|---|---|
|
Participants With Serious Adverse Events.
|
12 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: Up to Study Day 29Clinical Severity Score (CSC) measured by both survival time, time to recovery (defined by reaching levels 1-3 of the WHO modified 8-Point Ordinal Severity scale), and disease course while hospitalized and is calculated based on a procedure proposed by Shaw and Fay 2016 (https://doi.org/10.1002/sim.6950). CSC ranges from 1 to 57. Higher CSC is worse outcome. Clinical status assessment (WHO modified 8-Point Ordinal Severity scale) includes: 1. Not hospitalized, no limitations on activities. 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death
Outcome measures
| Measure |
COVID-19 Convalescent Plasma
n=40 Participants
COVID-19 Convalescent plasma on Study Day 1 in addition to standard care
COVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type
|
Standard of Care
n=39 Participants
Standard care alone
|
|---|---|---|
|
Clinical Severity Score
|
7 scored on a scale (CSC)
Interval 2.75 to 12.5
|
10 scored on a scale (CSC)
Interval 5.5 to 30.0
|
SECONDARY outcome
Timeframe: Up to Study Day 29Population: Population analyzed are only those who recovered. Remaining subjects either died or were still in hospital with WHO8 score \> 3 by Study Day 29.
Time to recovery, defined by time needed to reach levels 1-3 using the WHO modified 8-Point Ordinal Severity scale assessed daily while hospitalized and on Day 15, 22, and 29: 1. Not hospitalized, no limitations on activities. 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death
Outcome measures
| Measure |
COVID-19 Convalescent Plasma
n=38 Participants
COVID-19 Convalescent plasma on Study Day 1 in addition to standard care
COVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type
|
Standard of Care
n=26 Participants
Standard care alone
|
|---|---|---|
|
Clinical Status Assessment, Time to Recovery
|
7 days
Interval 2.25 to 11.75
|
7 days
Interval 4.25 to 9.75
|
SECONDARY outcome
Timeframe: Up to Study Day 29Population: subjects who never reach National Early Warning Score (NEWS) of ≤ 2 or discharged by Study Day 29 have outcome measure of Infinity
Time to discharge or to a National Early Warning Score (NEWS) of ≤ 2 and maintained for 24 hours, whichever occurs first. NEWS assessed daily while hospitalized until discharge or death and on Days 15 and 29. Higher NEWS is worse, range from 0 to 20.
Outcome measures
| Measure |
COVID-19 Convalescent Plasma
n=40 Participants
COVID-19 Convalescent plasma on Study Day 1 in addition to standard care
COVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type
|
Standard of Care
n=39 Participants
Standard care alone
|
|---|---|---|
|
National Early Warning Score (NEWS) Clinical Status Assessment
|
3 days
Interval 2.0 to 6.25
|
4 days
Interval 2.0 to 9.0
|
SECONDARY outcome
Timeframe: Daily while hospitalized and up to Study Day 29Population: All subjects were evaluated. Subjects who never had a day with WHO8 ordinal score of 5, 6, or 7 have outcome measurement of 0 days.
Days of supplemental oxygen while in hospital. defined as days with WHO8 ordinal score of 5, 6, or 7
Outcome measures
| Measure |
COVID-19 Convalescent Plasma
n=40 Participants
COVID-19 Convalescent plasma on Study Day 1 in addition to standard care
COVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type
|
Standard of Care
n=39 Participants
Standard care alone
|
|---|---|---|
|
Oxygenation
|
7 days
Interval 2.0 to 10.25
|
8 days
Interval 4.0 to 18.5
|
SECONDARY outcome
Timeframe: From enrollment to Day 29.Population: this endpoint was not measured due to redundancy
Incidence of new oxygenation use up to Day 29.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment to Day 29.Population: This was not measured due to redundancy of endpoints
Duration (days) of new oxygen use up to Day 29.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Daily while in hospital to Study Day 29.Population: All subjects were evaluated. Subjects who never had a day with WHO8 ordinal score of 6 have outcome measurement of 0 days.
Days of non-invasive ventilation/high flow oxygen up to Day 29 Defined by having a WHO8 ordinal scale of 6 = Hospitalized, on non-invasive ventilation or high flow oxygen devices
Outcome measures
| Measure |
COVID-19 Convalescent Plasma
n=40 Participants
COVID-19 Convalescent plasma on Study Day 1 in addition to standard care
COVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type
|
Standard of Care
n=39 Participants
Standard care alone
|
|---|---|---|
|
Non-invasive Ventilation/High Flow Oxygen Days up to Day 29
|
2 days
Interval 0.0 to 5.0
|
3 days
Interval 0.0 to 5.5
|
SECONDARY outcome
Timeframe: Daily while in hospital until Study Day 29number of participants with at least one day on non-invasive ventilation/high flow oxygen Defined by having a WHO8 ordinal scale of 6 = Hospitalized, on non-invasive ventilation or high flow oxygen devices
Outcome measures
| Measure |
COVID-19 Convalescent Plasma
n=40 Participants
COVID-19 Convalescent plasma on Study Day 1 in addition to standard care
COVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type
|
Standard of Care
n=39 Participants
Standard care alone
|
|---|---|---|
|
Number of Participants With at Least One Day on Non-invasive Ventilation/High Flow Oxygen up to Day 29
|
24 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Daily while in hospital to Study Day 29.Population: not measured due to redundancy with other endpoints (#8)
Days of non-invasive ventilation/high flow oxygen up to Day 29
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Daily while in hospital to Study Day 29Population: All subjects were evaluated. Subjects who never had a day with WHO8 ordinal score of 7 have outcome measurement of 0 days.
Days of mechanical ventilation or ECMO use (having a WHO8 ordinal score of 7 = Hospitalized, on invasive mechanical ventilation or ECMO) during the study in hospital until study day 29.
Outcome measures
| Measure |
COVID-19 Convalescent Plasma
n=40 Participants
COVID-19 Convalescent plasma on Study Day 1 in addition to standard care
COVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type
|
Standard of Care
n=39 Participants
Standard care alone
|
|---|---|---|
|
Ventilator/ECMO Days to Day 29
|
0 days
Interval 0.0 to 0.0
|
0 days
Interval 0.0 to 0.5
|
SECONDARY outcome
Timeframe: From enrollment to Day 29.number of subjects with new mechanical ventilation or ECMO use up to Day 29 since all subjects were not on mechanical ventilation or ECMO at baseline.
Outcome measures
| Measure |
COVID-19 Convalescent Plasma
n=40 Participants
COVID-19 Convalescent plasma on Study Day 1 in addition to standard care
COVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type
|
Standard of Care
n=39 Participants
Standard care alone
|
|---|---|---|
|
New Mechanical Ventilation or ECMO Use
|
5 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Daily while in hospital to Study Day 29Population: only includes subjects with new mechanical ventilation or ECMO
Days of new mechanical ventilation or ECMO use up to Day 29.
Outcome measures
| Measure |
COVID-19 Convalescent Plasma
n=5 Participants
COVID-19 Convalescent plasma on Study Day 1 in addition to standard care
COVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type
|
Standard of Care
n=10 Participants
Standard care alone
|
|---|---|---|
|
Duration of New Mechanical Ventilation or ECMO
|
7 days
Interval 4.0 to 8.0
|
12.5 days
Interval 10.0 to 20.5
|
SECONDARY outcome
Timeframe: To Study Day 29Duration (days) of first hospitalization. Time until death or discharge or Study Day 29
Outcome measures
| Measure |
COVID-19 Convalescent Plasma
n=40 Participants
COVID-19 Convalescent plasma on Study Day 1 in addition to standard care
COVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type
|
Standard of Care
n=39 Participants
Standard care alone
|
|---|---|---|
|
Duration of Hospitalization
|
7 days
Interval 2.75 to 12.0
|
9 days
Interval 5.0 to 19.5
|
SECONDARY outcome
Timeframe: 28 days from Study Day 128 day mortality.
Outcome measures
| Measure |
COVID-19 Convalescent Plasma
n=40 Participants
COVID-19 Convalescent plasma on Study Day 1 in addition to standard care
COVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type
|
Standard of Care
n=39 Participants
Standard care alone
|
|---|---|---|
|
Mortality
|
2 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Through Study Day 29Population: this endpoint is redundant with the primary endpoint
Number of subjects with SAEs through Day 29.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through Study Day 29Number of subjects with at least one Grade 3 or Grade 4 clinical and/or laboratory adverse events (AEs) through Day 29.
Outcome measures
| Measure |
COVID-19 Convalescent Plasma
n=40 Participants
COVID-19 Convalescent plasma on Study Day 1 in addition to standard care
COVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type
|
Standard of Care
n=39 Participants
Standard care alone
|
|---|---|---|
|
Number of Subjects With at Least One Grade 3 and Grade 4 Clinical and/or Laboratory Adverse Events Through Day 29
|
18 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Through Day 29Population: Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects.
Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \> baseline lab value.
Outcome measures
| Measure |
COVID-19 Convalescent Plasma
n=40 Participants
COVID-19 Convalescent plasma on Study Day 1 in addition to standard care
COVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type
|
Standard of Care
n=39 Participants
Standard care alone
|
|---|---|---|
|
Changes in WBC With Differential Through Day 29
|
1.45 THO/uL
Interval -1.3 to 3.3
|
2.50 THO/uL
Interval 0.25 to 3.3
|
SECONDARY outcome
Timeframe: Through Day 29Population: Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects.
Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \> baseline lab value.
Outcome measures
| Measure |
COVID-19 Convalescent Plasma
n=40 Participants
COVID-19 Convalescent plasma on Study Day 1 in addition to standard care
COVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type
|
Standard of Care
n=39 Participants
Standard care alone
|
|---|---|---|
|
Changes in Hemoglobin Measurement Through Day 29
|
-0.35 g/dL
Interval -1.2 to 0.325
|
-0.30 g/dL
Interval -1.9 to 0.9
|
SECONDARY outcome
Timeframe: Through Day 29.Population: Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects.
Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \> baseline lab value.
Outcome measures
| Measure |
COVID-19 Convalescent Plasma
n=40 Participants
COVID-19 Convalescent plasma on Study Day 1 in addition to standard care
COVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type
|
Standard of Care
n=39 Participants
Standard care alone
|
|---|---|---|
|
Changes in Platelets Measurement Through Day 29
|
38 10^3 platelets per uL
Interval -5.5 to 129.0
|
59 10^3 platelets per uL
Interval 4.5 to 94.5
|
SECONDARY outcome
Timeframe: Through Day 29.Population: Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects.
Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \> baseline lab value.
Outcome measures
| Measure |
COVID-19 Convalescent Plasma
n=40 Participants
COVID-19 Convalescent plasma on Study Day 1 in addition to standard care
COVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type
|
Standard of Care
n=39 Participants
Standard care alone
|
|---|---|---|
|
Changes in Creatinine Measurement Through Day 29
|
0.035 mg/dL
Interval -0.16 to 0.22
|
-0.050 mg/dL
Interval -0.255 to 0.055
|
SECONDARY outcome
Timeframe: Through Day 29.Population: Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects.
Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \> baseline lab value.
Outcome measures
| Measure |
COVID-19 Convalescent Plasma
n=40 Participants
COVID-19 Convalescent plasma on Study Day 1 in addition to standard care
COVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type
|
Standard of Care
n=39 Participants
Standard care alone
|
|---|---|---|
|
Changes in Glucose Measurement Through Day 29
|
-14.00 mg/dL
Interval -34.75 to 13.75
|
-20.00 mg/dL
Interval -48.5 to 5.0
|
SECONDARY outcome
Timeframe: Through Day 29Population: Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects. Standard of care arm has analyzed sample size of 38 because one subject did not have total bilirubin lab collected
Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \> baseline lab value.
Outcome measures
| Measure |
COVID-19 Convalescent Plasma
n=40 Participants
COVID-19 Convalescent plasma on Study Day 1 in addition to standard care
COVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type
|
Standard of Care
n=38 Participants
Standard care alone
|
|---|---|---|
|
Changes in Total Bilirubin Measurement Through Day 29
|
0.00 mg/dL
Interval -0.1 to 0.1
|
0.00 mg/dL
Interval 0.0 to 0.1
|
SECONDARY outcome
Timeframe: Through Day 29Population: Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects. Standard of care arm has analyzed sample size of 38 because one subject did not have ALT lab collected
Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \> baseline lab value.
Outcome measures
| Measure |
COVID-19 Convalescent Plasma
n=40 Participants
COVID-19 Convalescent plasma on Study Day 1 in addition to standard care
COVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type
|
Standard of Care
n=38 Participants
Standard care alone
|
|---|---|---|
|
Changes in ALT Measurement Through Day 29
|
0.00 U/L
Interval -5.75 to 5.0
|
-1.00 U/L
Interval -11.5 to 8.25
|
SECONDARY outcome
Timeframe: Through Day 29.Population: Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects. Standard of care arm has analyzed sample size of 38 because one subject did not have AST lab collected
Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \> baseline lab value.
Outcome measures
| Measure |
COVID-19 Convalescent Plasma
n=40 Participants
COVID-19 Convalescent plasma on Study Day 1 in addition to standard care
COVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type
|
Standard of Care
n=38 Participants
Standard care alone
|
|---|---|---|
|
Changes in AST Measurement Through Day 29
|
-7.00 U/L
Interval -16.0 to 0.0
|
-6.00 U/L
Interval -16.0 to 0.75
|
SECONDARY outcome
Timeframe: Through Day 29.Population: Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects. Plasma arm analyzed sample size is 38 because 2 subjects did not have PT test collected. Standard of care arm analyzed sample size is 37 because 2 subjects did not have PT test collected.
Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \> baseline lab value.
Outcome measures
| Measure |
COVID-19 Convalescent Plasma
n=38 Participants
COVID-19 Convalescent plasma on Study Day 1 in addition to standard care
COVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type
|
Standard of Care
n=37 Participants
Standard care alone
|
|---|---|---|
|
Changes in PT Measurement Laboratory Through Day 29
|
0.0 seconds
Interval -1.175 to 0.55
|
0.0 seconds
Interval -0.8 to 1.2
|
Adverse Events
Treatment
Control
Serious adverse events
| Measure |
Treatment
n=40 participants at risk
On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care
|
Control
n=39 participants at risk
Standard of care treatment administered only
|
|---|---|---|
|
Vascular disorders
Acute CNS Ischemia
|
5.0%
2/40 • Number of events 2 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
2.6%
1/39 • Number of events 1 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Nervous system disorders
Altered Mental Status
|
2.5%
1/40 • Number of events 1 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
2.6%
1/39 • Number of events 1 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Cardiac disorders
Arrhythmia (by ECG or physical examination)
|
2.5%
1/40 • Number of events 1 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
0.00%
0/39 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Investigations
Creatinine High
|
0.00%
0/40 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
2.6%
1/39 • Number of events 1 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Endocrine disorders
Glucose low
|
0.00%
0/40 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
3.1%
1/32 • Number of events 1 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea or Respiratory Distress
|
20.0%
8/40 • Number of events 10 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
33.3%
13/39 • Number of events 18 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Blood and lymphatic system disorders
Hemorrhage
|
2.5%
1/40 • Number of events 1 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
0.00%
0/39 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Vascular disorders
Hypotension
|
0.00%
0/40 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
5.1%
2/39 • Number of events 3 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
General disorders
Pain
|
7.5%
3/40 • Number of events 3 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
2.6%
1/39 • Number of events 1 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Nervous system disorders
Syncope
|
2.5%
1/40 • Number of events 1 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
0.00%
0/39 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Vascular disorders
Embolism
|
2.5%
1/40 • Number of events 1 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
0.00%
0/39 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/40 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
2.6%
1/39 • Number of events 1 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Nervous system disorders
Neurosensory alteration
|
0.00%
0/40 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
2.6%
1/39 • Number of events 1 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Blood and lymphatic system disorders
Thrombosis
|
2.5%
1/40 • Number of events 1 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
2.6%
1/39 • Number of events 1 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Nervous system disorders
Headache
|
2.5%
1/40 • Number of events 1 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
0.00%
0/39 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
Other adverse events
| Measure |
Treatment
n=40 participants at risk
On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care
|
Control
n=39 participants at risk
Standard of care treatment administered only
|
|---|---|---|
|
Metabolism and nutrition disorders
Acidosis
|
15.0%
6/40 • Number of events 7 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
10.3%
4/39 • Number of events 4 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Metabolism and nutrition disorders
Albumin, Low
|
5.0%
2/40 • Number of events 3 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
10.3%
4/39 • Number of events 4 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Metabolism and nutrition disorders
Alkalosis
|
5.0%
2/40 • Number of events 2 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
0.00%
0/39 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Nervous system disorders
Altered Mental Status
|
5.0%
2/40 • Number of events 2 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
12.8%
5/39 • Number of events 5 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Cardiac disorders
Arrhythmia (by ECG or physical examination)
|
0.00%
0/40 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
12.8%
5/39 • Number of events 5 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Investigations
AST, High
|
5.0%
2/40 • Number of events 2 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
5.1%
2/39 • Number of events 2 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Vascular disorders
Blood Pressure Abnormalities Hypertension (with the lowest reading taken after repeat testing durin
|
2.5%
1/40 • Number of events 1 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
20.5%
8/39 • Number of events 11 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Investigations
Creatinine, High
|
10.0%
4/40 • Number of events 4 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
12.8%
5/39 • Number of events 6 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea or Respiratory Distress
|
17.5%
7/40 • Number of events 8 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
35.9%
14/39 • Number of events 32 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
General disorders
Fever (non-axillary temperatures only)
|
7.5%
3/40 • Number of events 4 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
12.8%
5/39 • Number of events 7 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
0.00%
0/40 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
5.1%
2/39 • Number of events 2 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Metabolism and nutrition disorders
Glucose (mg/dL; mmol/L) Fasting, High
|
12.5%
5/40 • Number of events 6 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
17.9%
7/39 • Number of events 9 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/40 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
7.7%
3/39 • Number of events 3 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Blood and lymphatic system disorders
Hemoglobin, Low (g/dL; mmol/L) >= 13 years of age (female only)
|
15.0%
6/40 • Number of events 9 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
20.5%
8/39 • Number of events 14 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Vascular disorders
Hypotension
|
10.0%
4/40 • Number of events 4 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
17.9%
7/39 • Number of events 9 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Blood and lymphatic system disorders
Platelets, Decreased
|
2.5%
1/40 • Number of events 1 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
7.7%
3/39 • Number of events 3 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Renal and urinary disorders
Proteinuria
|
5.0%
2/40 • Number of events 2 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
2.6%
1/39 • Number of events 1 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Nervous system disorders
Acute CNS Ischemia
|
2.5%
1/40 • Number of events 1 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
5.1%
2/39 • Number of events 3 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Investigations
ALT High
|
0.00%
0/40 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
5.1%
2/39 • Number of events 2 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Investigations
Calcium, Low (mg/dL; mmol/L) >= 7 days of age
|
2.5%
1/40 • Number of events 1 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
5.1%
2/39 • Number of events 2 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Blood and lymphatic system disorders
Hemoglobin, Low (g/dL; mmol/L) >= 13 years of age (male only)
|
10.0%
4/40 • Number of events 4 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
15.4%
6/39 • Number of events 10 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
General disorders
Pain (not associated with study agent injections and not specified elsewhere)
|
2.5%
1/40 • Number of events 1 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
5.1%
2/39 • Number of events 2 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Skin and subcutaneous tissue disorders
Pruritus (without skin lesions)
|
0.00%
0/40 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
5.1%
2/39 • Number of events 2 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
|
Blood and lymphatic system disorders
Thrombosis or Embolism Report only one
|
0.00%
0/40 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
5.1%
2/39 • Number of events 2 • Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place