Trial Outcomes & Findings for VA CoronavirUs Research and Efficacy Studies-1 (NCT NCT04539275)
NCT ID: NCT04539275
Last Updated: 2022-09-23
Results Overview
Respiratory failure is defined as requiring mechanical ventilation, with or without endotracheal intubations, or extra-corporeal membrane oxygenation.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
75 participants
Primary outcome timeframe
Day 1 through Day 28
Results posted on
2022-09-23
Participant Flow
Participant milestones
| Measure |
Convalescent Plasma
The study intervention consists of intravenous administration of 200-500 mL of convalescent plasma administered in two equally divided doses, less than 12 hours apart.
Convalescent Plasma: Convalescent plasma from persons recovered from SARS-CoV-2 is being used to treat hospitalized individuals with complicated COVID-19 infection.
|
Masked Saline Placebo
The study intervention consists of intravenous administration of 200-500 mL of 0.9% saline administered in two equally divided doses, less than 12 hours apart.
Masked Saline Placebo: 0.9% saline solution will be used as the Masked Saline Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
40
|
|
Overall Study
Received Study Product
|
32
|
40
|
|
Overall Study
COMPLETED
|
29
|
35
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
Convalescent Plasma
The study intervention consists of intravenous administration of 200-500 mL of convalescent plasma administered in two equally divided doses, less than 12 hours apart.
Convalescent Plasma: Convalescent plasma from persons recovered from SARS-CoV-2 is being used to treat hospitalized individuals with complicated COVID-19 infection.
|
Masked Saline Placebo
The study intervention consists of intravenous administration of 200-500 mL of 0.9% saline administered in two equally divided doses, less than 12 hours apart.
Masked Saline Placebo: 0.9% saline solution will be used as the Masked Saline Placebo
|
|---|---|---|
|
Overall Study
Death
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
Lab test was not done for 2 participants in the Masked Saline Placebo group.
Baseline characteristics by cohort
| Measure |
Convalescent Plasma
n=35 Participants
The study intervention consists of intravenous administration of 200-500 mL of convalescent plasma administered in two equally divided doses, less than 12 hours apart.
Convalescent Plasma: Convalescent plasma from persons recovered from SARS-CoV-2 is being used to treat hospitalized individuals with complicated COVID-19 infection.
|
Masked Saline Placebo
n=40 Participants
The study intervention consists of intravenous administration of 200-500 mL of 0.9% saline administered in two equally divided doses, less than 12 hours apart.
Masked Saline Placebo: 0.9% saline solution will be used as the Masked Saline Placebo
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=35 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=75 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=35 Participants
|
18 Participants
n=40 Participants
|
34 Participants
n=75 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=35 Participants
|
22 Participants
n=40 Participants
|
41 Participants
n=75 Participants
|
|
Age, Continuous
|
65.6 years
STANDARD_DEVIATION 14.5 • n=35 Participants
|
67 years
STANDARD_DEVIATION 11.5 • n=40 Participants
|
66.4 years
STANDARD_DEVIATION 13 • n=75 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=35 Participants
|
2 Participants
n=40 Participants
|
3 Participants
n=75 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=35 Participants
|
38 Participants
n=40 Participants
|
72 Participants
n=75 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=35 Participants
|
9 Participants
n=40 Participants
|
17 Participants
n=75 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=35 Participants
|
31 Participants
n=40 Participants
|
57 Participants
n=75 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=35 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=75 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=35 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=75 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=35 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=75 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=35 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=75 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=35 Participants
|
15 Participants
n=40 Participants
|
26 Participants
n=75 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=35 Participants
|
22 Participants
n=40 Participants
|
43 Participants
n=75 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=35 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=75 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=35 Participants
|
2 Participants
n=40 Participants
|
4 Participants
n=75 Participants
|
|
Region of Enrollment
United States
|
35 Participants
n=35 Participants
|
40 Participants
n=40 Participants
|
75 Participants
n=75 Participants
|
|
Clinical Status
Ambulatory, no limitation of activity
|
0 Participants
n=35 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=75 Participants
|
|
Clinical Status
Ambulatory, limitation of activity and/or home oxygen
|
0 Participants
n=35 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=75 Participants
|
|
Clinical Status
Hospitalized Mild Disease, no oxygen therapy
|
0 Participants
n=35 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=75 Participants
|
|
Clinical Status
Hospitalized Mild Disease, oxygen by mask or nasal prong
|
34 Participants
n=35 Participants
|
40 Participants
n=40 Participants
|
74 Participants
n=75 Participants
|
|
Clinical Status
Hospitalized Severe Disease, humidified high-flow oxygen
|
1 Participants
n=35 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=75 Participants
|
|
Clinical Status
Hospitalized Severe Disease, non-invasive ventilation
|
0 Participants
n=35 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=75 Participants
|
|
Clinical Status
Hospitalized Severe Disease, intubation and mechanical ventilation
|
0 Participants
n=35 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=75 Participants
|
|
Clinical Status
Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO
|
0 Participants
n=35 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=75 Participants
|
|
Clinical Status
Death
|
0 Participants
n=35 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=75 Participants
|
|
NEWS2
|
3 units on a scale
n=35 Participants
|
4 units on a scale
n=40 Participants
|
4 units on a scale
n=75 Participants
|
|
White Blood Cell (WBC) Count
|
7.9 K cells/mcL
n=35 Participants
|
6.8 K cells/mcL
n=40 Participants
|
7.4 K cells/mcL
n=75 Participants
|
|
Neutrophil Count
|
6.3 K cells/mcL
n=35 Participants • Lab test was not done for 2 participants in the Masked Saline Placebo group.
|
5.7 K cells/mcL
n=38 Participants • Lab test was not done for 2 participants in the Masked Saline Placebo group.
|
6 K cells/mcL
n=73 Participants • Lab test was not done for 2 participants in the Masked Saline Placebo group.
|
|
Total Lymphocyte Count
|
0.9 K cells/mcL
n=35 Participants • Lab test was not done for 2 participants in the Masked Saline Placebo group.
|
0.8 K cells/mcL
n=38 Participants • Lab test was not done for 2 participants in the Masked Saline Placebo group.
|
0.9 K cells/mcL
n=73 Participants • Lab test was not done for 2 participants in the Masked Saline Placebo group.
|
|
Hemoglobin
|
13.5 g/dL
n=35 Participants
|
13.5 g/dL
n=40 Participants
|
13.5 g/dL
n=75 Participants
|
|
Platelets
|
246 K cells/mcL
n=35 Participants
|
207 K cells/mcL
n=40 Participants
|
229 K cells/mcL
n=75 Participants
|
|
Creatinine
|
0.9 mg/dL
n=35 Participants
|
1 mg/dL
n=40 Participants
|
1 mg/dL
n=75 Participants
|
|
Glucose
|
144 mg/dL
n=35 Participants
|
160 mg/dL
n=40 Participants
|
154 mg/dL
n=75 Participants
|
|
Alanine Transaminase (ALT/SGPT)
|
30 U/L
n=34 Participants • Lab test was not done for 1 participant in the Convalescent Plasma group.
|
31 U/L
n=40 Participants • Lab test was not done for 1 participant in the Convalescent Plasma group.
|
30 U/L
n=74 Participants • Lab test was not done for 1 participant in the Convalescent Plasma group.
|
|
Aspartate Transaminase (AST/SGOT)
|
29 U/L
n=34 Participants • Lab test was not done for 1 participant in the Convalescent Plasma group.
|
35 U/L
n=40 Participants • Lab test was not done for 1 participant in the Convalescent Plasma group.
|
34 U/L
n=74 Participants • Lab test was not done for 1 participant in the Convalescent Plasma group.
|
|
International Normalized Ratio (INR)
|
1.11 unitless
n=31 Participants • Lab test was not done for 4 participants in the Convalescent Plasma group and 3 participants in the Masked Saline Placebo group.
|
1.2 unitless
n=37 Participants • Lab test was not done for 4 participants in the Convalescent Plasma group and 3 participants in the Masked Saline Placebo group.
|
1.15 unitless
n=68 Participants • Lab test was not done for 4 participants in the Convalescent Plasma group and 3 participants in the Masked Saline Placebo group.
|
PRIMARY outcome
Timeframe: Day 1 through Day 28Population: The primary outcome cannot be determined for 5 participants (4 in Convalescent Plasma, and 1 in Masked Saline Placebo) who terminated early from the study
Respiratory failure is defined as requiring mechanical ventilation, with or without endotracheal intubations, or extra-corporeal membrane oxygenation.
Outcome measures
| Measure |
Convalescent Plasma
n=31 Participants
The study intervention consists of intravenous administration of 200-500 mL of convalescent plasma administered in two equally divided doses, less than 12 hours apart.
Convalescent Plasma: Convalescent plasma from persons recovered from SARS-CoV-2 is being used to treat hospitalized individuals with complicated COVID-19 infection.
|
Masked Saline Placebo
n=39 Participants
The study intervention consists of intravenous administration of 200-500 mL of 0.9% saline administered in two equally divided doses, less than 12 hours apart.
Masked Saline Placebo: 0.9% saline solution will be used as the Masked Saline Placebo
|
|---|---|---|
|
Proportion of Participants Developing Acute Hypoxemic Respiratory Failure or All-cause Death
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 28Population: All randomized participants are included in this analysis.
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the Modified World Health Organization (WHO) 8-point Ordinal Scale for Clinical Improvement : 1) Ambulatory, no limitation of activity; 2) Ambulatory, limitation of activity and/or home oxygen; 3) Hospitalized Mild Disease, no oxygen therapy.
Outcome measures
| Measure |
Convalescent Plasma
n=35 Participants
The study intervention consists of intravenous administration of 200-500 mL of convalescent plasma administered in two equally divided doses, less than 12 hours apart.
Convalescent Plasma: Convalescent plasma from persons recovered from SARS-CoV-2 is being used to treat hospitalized individuals with complicated COVID-19 infection.
|
Masked Saline Placebo
n=40 Participants
The study intervention consists of intravenous administration of 200-500 mL of 0.9% saline administered in two equally divided doses, less than 12 hours apart.
Masked Saline Placebo: 0.9% saline solution will be used as the Masked Saline Placebo
|
|---|---|---|
|
Time (in Days) to Recovery
|
6 Days
Interval 4.0 to 9.0
|
6 Days
Interval 5.0 to 12.5
|
SECONDARY outcome
Timeframe: Day 1 through Day 28Population: All randomized participants are included in the analysis
Defined as the first day on which the subject died from any cause or had respiratory failure. Respiratory failure is defined by requiring mechanical ventilation, with or without endotracheal intubations, or extra-corporeal membrane oxygenation.
Outcome measures
| Measure |
Convalescent Plasma
n=35 Participants
The study intervention consists of intravenous administration of 200-500 mL of convalescent plasma administered in two equally divided doses, less than 12 hours apart.
Convalescent Plasma: Convalescent plasma from persons recovered from SARS-CoV-2 is being used to treat hospitalized individuals with complicated COVID-19 infection.
|
Masked Saline Placebo
n=40 Participants
The study intervention consists of intravenous administration of 200-500 mL of 0.9% saline administered in two equally divided doses, less than 12 hours apart.
Masked Saline Placebo: 0.9% saline solution will be used as the Masked Saline Placebo
|
|---|---|---|
|
Time (in Days) to Death or Respiratory Failure
|
NA days
The median and inter-quartile range cannot be calculated because \<25% of study participants experienced this event.
|
NA days
The median and inter-quartile range cannot be calculated because \<25% of study participants experienced this event.
|
SECONDARY outcome
Timeframe: Day 1 through Day 28Population: This secondary outcome cannot be determined for 5 participants (4 in Convalescent Plasma, and 1 in Masked Saline Placebo) who terminated early from the study
Defined as the proportion of subjects who died from any cause, had respiratory failure, or who required humidified heater high-flow cannula (HHHFNC) at \>= 15 Lpm. Respiratory failure is defined by requiring mechanical ventilation, with or without endotracheal intubations, or extra-corporeal membrane oxygenation.
Outcome measures
| Measure |
Convalescent Plasma
n=31 Participants
The study intervention consists of intravenous administration of 200-500 mL of convalescent plasma administered in two equally divided doses, less than 12 hours apart.
Convalescent Plasma: Convalescent plasma from persons recovered from SARS-CoV-2 is being used to treat hospitalized individuals with complicated COVID-19 infection.
|
Masked Saline Placebo
n=39 Participants
The study intervention consists of intravenous administration of 200-500 mL of 0.9% saline administered in two equally divided doses, less than 12 hours apart.
Masked Saline Placebo: 0.9% saline solution will be used as the Masked Saline Placebo
|
|---|---|---|
|
Proportion of Patients Who Died From Any Cause, Had Respiratory Failure, or Required Humidified Heated High-flow Nasal Cannula (HHHFNC) at >= 15 Lpm
|
4 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 28Population: All randomized participants were included in this analysis.
Time to death or respiratory failure is defined as the first day on which the subject died from any cause, had respiratory failure (defined above), or who required HHHFNC at \>= 15 Lpm.
Outcome measures
| Measure |
Convalescent Plasma
n=35 Participants
The study intervention consists of intravenous administration of 200-500 mL of convalescent plasma administered in two equally divided doses, less than 12 hours apart.
Convalescent Plasma: Convalescent plasma from persons recovered from SARS-CoV-2 is being used to treat hospitalized individuals with complicated COVID-19 infection.
|
Masked Saline Placebo
n=40 Participants
The study intervention consists of intravenous administration of 200-500 mL of 0.9% saline administered in two equally divided doses, less than 12 hours apart.
Masked Saline Placebo: 0.9% saline solution will be used as the Masked Saline Placebo
|
|---|---|---|
|
Time (in Days) to Death, Respiratory Failure, or HHHFNC at >= 15 Lpm
|
NA days
The median and inter-quartile range cannot be calculated because \<25% of study participants experienced this event.
|
NA days
The median and inter-quartile range cannot be calculated because \<25% of study participants experienced this event.
|
SECONDARY outcome
Timeframe: Day 1 through Day 28Population: This secondary outcome cannot be determined for 5 participants (4 in Convalescent Plasma, and 1 in Masked Saline Placebo) who terminated early from the study
Death for Any Reason
Outcome measures
| Measure |
Convalescent Plasma
n=31 Participants
The study intervention consists of intravenous administration of 200-500 mL of convalescent plasma administered in two equally divided doses, less than 12 hours apart.
Convalescent Plasma: Convalescent plasma from persons recovered from SARS-CoV-2 is being used to treat hospitalized individuals with complicated COVID-19 infection.
|
Masked Saline Placebo
n=39 Participants
The study intervention consists of intravenous administration of 200-500 mL of 0.9% saline administered in two equally divided doses, less than 12 hours apart.
Masked Saline Placebo: 0.9% saline solution will be used as the Masked Saline Placebo
|
|---|---|---|
|
Number of Participants With 28-day All-cause Mortality
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up through 28 days.Population: All randomized participants were included in this analysis.
Number of Days until the Modified WHO Clinical Status Improved by at Least One Category Modified WHO 8-point Ordinal Scale for Clinical Improvement. The scale is as follows: 0) No clinical or Virologic evidence of infection; 1) Ambulatory, no limitation of activity; 2) Ambulatory, limitation of activity and/or home oxygen; 3) Hospitalized Mild Disease, no oxygen therapy; 4) Hospitalized Mild Disease, oxygen by mask or nasal prong; 5a) Hospitalized Severe Disease, humidified high-flow oxygen; 5b) Hospitalized Severe Disease, non-invasive ventilation; 6) Hospitalized Severe Disease, intubation and mechanical ventilation; 7) Hospitalized Severe Disease, ventilation + additional organ support-pressors, renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO); 8) Death. The higher the score, the worse the outcome.
Outcome measures
| Measure |
Convalescent Plasma
n=35 Participants
The study intervention consists of intravenous administration of 200-500 mL of convalescent plasma administered in two equally divided doses, less than 12 hours apart.
Convalescent Plasma: Convalescent plasma from persons recovered from SARS-CoV-2 is being used to treat hospitalized individuals with complicated COVID-19 infection.
|
Masked Saline Placebo
n=40 Participants
The study intervention consists of intravenous administration of 200-500 mL of 0.9% saline administered in two equally divided doses, less than 12 hours apart.
Masked Saline Placebo: 0.9% saline solution will be used as the Masked Saline Placebo
|
|---|---|---|
|
Time to an Improvement of at Least One Category Using an Ordinal Scale
|
6 days
Interval 4.0 to 9.0
|
6 days
Interval 5.0 to 12.5
|
SECONDARY outcome
Timeframe: Up through 28 days.Population: All randomized participants were included in this analysis.
Number of Days until the Modified WHO Clinical Status Improved by at Least Two Categories Modified WHO 8-point Ordinal Scale for Clinical Improvement. The scale is as follows: 0) No clinical or Virologic evidence of infection; 1) Ambulatory, no limitation of activity; 2) Ambulatory, limitation of activity and/or home oxygen; 3) Hospitalized Mild Disease, no oxygen therapy; 4) Hospitalized Mild Disease, oxygen by mask or nasal prong; 5a) Hospitalized Severe Disease, humidified high-flow oxygen; 5b) Hospitalized Severe Disease, non-invasive ventilation; 6) Hospitalized Severe Disease, intubation and mechanical ventilation; 7) Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO; 8) Death. The higher the score, the worse the outcome.
Outcome measures
| Measure |
Convalescent Plasma
n=35 Participants
The study intervention consists of intravenous administration of 200-500 mL of convalescent plasma administered in two equally divided doses, less than 12 hours apart.
Convalescent Plasma: Convalescent plasma from persons recovered from SARS-CoV-2 is being used to treat hospitalized individuals with complicated COVID-19 infection.
|
Masked Saline Placebo
n=40 Participants
The study intervention consists of intravenous administration of 200-500 mL of 0.9% saline administered in two equally divided doses, less than 12 hours apart.
Masked Saline Placebo: 0.9% saline solution will be used as the Masked Saline Placebo
|
|---|---|---|
|
Time to an Improvement of at Least Two Categories Using an Ordinal Scale
|
7 days
Interval 5.0 to 13.0
|
7 days
Interval 5.0 to 16.0
|
SECONDARY outcome
Timeframe: Days 2, 4, 7, 11, 14, 21, and 28Population: This secondary outcome cannot be determined for 3 participants (3 in Convalescent Plasma, and 0 in Masked Saline Placebo) who terminated on the day of randomization.
Modified WHO 8-point Ordinal Scale for Clinical Improvement. The scale is as follows: 0) No clinical or Virologic evidence of infection; 1) Ambulatory, no limitation of activity; 2) Ambulatory, limitation of activity and/or home oxygen; 3) Hospitalized Mild Disease, no oxygen therapy; 4) Hospitalized Mild Disease, oxygen by mask or nasal prong; 5a) Hospitalized Severe Disease, humidified high-flow oxygen; 5b) Hospitalized Severe Disease, non-invasive ventilation; 6) Hospitalized Severe Disease, intubation and mechanical ventilation; 7) Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO; 8) Death. The higher the score, the worse the outcome.
Outcome measures
| Measure |
Convalescent Plasma
n=32 Participants
The study intervention consists of intravenous administration of 200-500 mL of convalescent plasma administered in two equally divided doses, less than 12 hours apart.
Convalescent Plasma: Convalescent plasma from persons recovered from SARS-CoV-2 is being used to treat hospitalized individuals with complicated COVID-19 infection.
|
Masked Saline Placebo
n=40 Participants
The study intervention consists of intravenous administration of 200-500 mL of 0.9% saline administered in two equally divided doses, less than 12 hours apart.
Masked Saline Placebo: 0.9% saline solution will be used as the Masked Saline Placebo
|
|---|---|---|
|
Participant's Clinical Status by Ordinal Scale
Day 2 · Ambulatory, no limitation of activity
|
0 Participants
|
0 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 2 · Ambulatory, limitation of activity and/or home oxygen
|
0 Participants
|
0 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 2 · Hospitalized Mild Disease, no oxygen therapy
|
1 Participants
|
1 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 2 · Hospitalized Mild Disease, oxygen by mask or nasal prong
|
28 Participants
|
35 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 2 · Hospitalized Severe Disease, humidified high-flow oxygen
|
1 Participants
|
3 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 2 · Hospitalized Severe Disease, non-invasive ventilation
|
2 Participants
|
0 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 2 · Hospitalized Severe Disease, intubation and mechanical ventilation
|
0 Participants
|
0 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 2 · Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO
|
0 Participants
|
1 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 2 · Death
|
0 Participants
|
0 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 4 · Ambulatory, no limitation of activity
|
2 Participants
|
2 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 4 · Ambulatory, limitation of activity and/or home oxygen
|
2 Participants
|
6 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 4 · Hospitalized Mild Disease, no oxygen therapy
|
6 Participants
|
1 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 4 · Hospitalized Mild Disease, oxygen by mask or nasal prong
|
19 Participants
|
23 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 4 · Hospitalized Severe Disease, humidified high-flow oxygen
|
1 Participants
|
6 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 4 · Hospitalized Severe Disease, non-invasive ventilation
|
0 Participants
|
0 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 4 · Hospitalized Severe Disease, intubation and mechanical ventilation
|
1 Participants
|
1 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 4 · Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO
|
1 Participants
|
1 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 4 · Death
|
0 Participants
|
0 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 7 · Ambulatory, no limitation of activity
|
6 Participants
|
4 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 7 · Ambulatory, limitation of activity and/or home oxygen
|
11 Participants
|
17 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 7 · Hospitalized Mild Disease, no oxygen therapy
|
2 Participants
|
3 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 7 · Hospitalized Mild Disease, oxygen by mask or nasal prong
|
8 Participants
|
10 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 7 · Hospitalized Severe Disease, humidified high-flow oxygen
|
2 Participants
|
3 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 7 · Hospitalized Severe Disease, non-invasive ventilation
|
0 Participants
|
0 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 7 · Hospitalized Severe Disease, intubation and mechanical ventilation
|
1 Participants
|
1 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 7 · Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO
|
0 Participants
|
1 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 7 · Death
|
0 Participants
|
0 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 11 · Ambulatory, no limitation of activity
|
5 Participants
|
5 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 11 · Ambulatory, limitation of activity and/or home oxygen
|
17 Participants
|
23 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 11 · Hospitalized Mild Disease, no oxygen therapy
|
3 Participants
|
1 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 11 · Hospitalized Mild Disease, oxygen by mask or nasal prong
|
2 Participants
|
6 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 11 · Hospitalized Severe Disease, humidified high-flow oxygen
|
2 Participants
|
1 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 11 · Hospitalized Severe Disease, non-invasive ventilation
|
0 Participants
|
0 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 11 · Hospitalized Severe Disease, intubation and mechanical ventilation
|
1 Participants
|
0 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 11 · Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO
|
0 Participants
|
1 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 11 · Death
|
0 Participants
|
1 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 14 · Ambulatory, no limitation of activity
|
6 Participants
|
5 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 14 · Ambulatory, limitation of activity and/or home oxygen
|
18 Participants
|
23 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 14 · Hospitalized Mild Disease, no oxygen therapy
|
2 Participants
|
2 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 14 · Death
|
0 Participants
|
0 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 14 · Hospitalized Mild Disease, oxygen by mask or nasal prong
|
2 Participants
|
5 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 14 · Hospitalized Severe Disease, humidified high-flow oxygen
|
0 Participants
|
1 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 14 · Hospitalized Severe Disease, non-invasive ventilation
|
0 Participants
|
0 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 14 · Hospitalized Severe Disease, intubation and mechanical ventilation
|
1 Participants
|
0 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 14 · Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO
|
0 Participants
|
0 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 21 · Ambulatory, no limitation of activity
|
7 Participants
|
9 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 21 · Ambulatory, limitation of activity and/or home oxygen
|
16 Participants
|
24 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 21 · Hospitalized Mild Disease, no oxygen therapy
|
3 Participants
|
1 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 21 · Hospitalized Mild Disease, oxygen by mask or nasal prong
|
2 Participants
|
2 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 21 · Hospitalized Severe Disease, humidified high-flow oxygen
|
0 Participants
|
0 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 21 · Hospitalized Severe Disease, non-invasive ventilation
|
0 Participants
|
0 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 21 · Hospitalized Severe Disease, intubation and mechanical ventilation
|
1 Participants
|
0 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 21 · Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO
|
0 Participants
|
0 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 21 · Death
|
0 Participants
|
0 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 28 · Ambulatory, no limitation of activity
|
6 Participants
|
11 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 28 · Ambulatory, limitation of activity and/or home oxygen
|
20 Participants
|
23 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 28 · Hospitalized Mild Disease, no oxygen therapy
|
0 Participants
|
0 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 28 · Hospitalized Mild Disease, oxygen by mask or nasal prong
|
3 Participants
|
1 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 28 · Hospitalized Severe Disease, humidified high-flow oxygen
|
0 Participants
|
0 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 28 · Hospitalized Severe Disease, non-invasive ventilation
|
0 Participants
|
0 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 28 · Hospitalized Severe Disease, intubation and mechanical ventilation
|
0 Participants
|
0 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 28 · Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO
|
0 Participants
|
0 Participants
|
|
Participant's Clinical Status by Ordinal Scale
Day 28 · Death
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline to Days 2, 4, 7, 11, 14, 21, and 28.Population: This secondary outcome cannot be determined for 3 participants (3 in Convalescent Plasma, and 0 in Masked Saline Placebo) who terminated on the day of randomization.
Change in the Modified WHO Clinical Status Modified WHO 8-point Ordinal Scale for Clinical Improvement. The scale is as follows: 0) No clinical or Virologic evidence of infection; 1) Ambulatory, no limitation of activity; 2) Ambulatory, limitation of activity and/or home oxygen; 3) Hospitalized Mild Disease, no oxygen therapy; 4) Hospitalized Mild Disease, oxygen by mask or nasal prong; 5a) Hospitalized Severe Disease, humidified high-flow oxygen; 5b) Hospitalized Severe Disease, non-invasive ventilation; 6) Hospitalized Severe Disease, intubation and mechanical ventilation; 7) Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO; 8) Death. The higher the score, the worse the outcome.
Outcome measures
| Measure |
Convalescent Plasma
n=32 Participants
The study intervention consists of intravenous administration of 200-500 mL of convalescent plasma administered in two equally divided doses, less than 12 hours apart.
Convalescent Plasma: Convalescent plasma from persons recovered from SARS-CoV-2 is being used to treat hospitalized individuals with complicated COVID-19 infection.
|
Masked Saline Placebo
n=40 Participants
The study intervention consists of intravenous administration of 200-500 mL of 0.9% saline administered in two equally divided doses, less than 12 hours apart.
Masked Saline Placebo: 0.9% saline solution will be used as the Masked Saline Placebo
|
|---|---|---|
|
Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 2
|
0 units on a scale
Interval -1.0 to 1.0
|
0 units on a scale
Interval -1.0 to 3.0
|
|
Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 4
|
0 units on a scale
Interval -3.0 to 3.0
|
0 units on a scale
Interval -3.0 to 3.0
|
|
Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 7
|
-2 units on a scale
Interval -3.0 to 1.0
|
-2 units on a scale
Interval -3.0 to 3.0
|
|
Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 11
|
-2 units on a scale
Interval -3.0 to 1.0
|
-2 units on a scale
Interval -3.0 to 4.0
|
|
Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 14
|
-2 units on a scale
Interval -3.0 to 1.0
|
-2 units on a scale
Interval -3.0 to 1.0
|
|
Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 21
|
-2 units on a scale
Interval -3.0 to 1.0
|
-2 units on a scale
Interval -3.0 to 0.0
|
|
Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 28
|
-2 units on a scale
Interval -3.0 to 0.0
|
-2 units on a scale
Interval -3.0 to 0.0
|
SECONDARY outcome
Timeframe: From Baseline to Days 2, 4, 7, 11, 14, 21, and 28.Population: This secondary outcome cannot be determined for 3 participants (3 in Convalescent Plasma, and 0 in Masked Saline Placebo) who terminated on the day of randomization.
Categorical Change in the Modified WHO 8-point Ordinal Scale for Clinical Improvement Modified WHO 8-point Ordinal Scale for Clinical Improvement. The scale is as follows: 0) No clinical or Virologic evidence of infection; 1) Ambulatory, no limitation of activity; 2) Ambulatory, limitation of activity and/or home oxygen; 3) Hospitalized Mild Disease, no oxygen therapy; 4) Hospitalized Mild Disease, oxygen by mask or nasal prong; 5a) Hospitalized Severe Disease, humidified high-flow oxygen; 5b) Hospitalized Severe Disease, non-invasive ventilation; 6) Hospitalized Severe Disease, intubation and mechanical ventilation; 7) Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO; 8) Death. The higher the score, the worse the outcome.
Outcome measures
| Measure |
Convalescent Plasma
n=32 Participants
The study intervention consists of intravenous administration of 200-500 mL of convalescent plasma administered in two equally divided doses, less than 12 hours apart.
Convalescent Plasma: Convalescent plasma from persons recovered from SARS-CoV-2 is being used to treat hospitalized individuals with complicated COVID-19 infection.
|
Masked Saline Placebo
n=40 Participants
The study intervention consists of intravenous administration of 200-500 mL of 0.9% saline administered in two equally divided doses, less than 12 hours apart.
Masked Saline Placebo: 0.9% saline solution will be used as the Masked Saline Placebo
|
|---|---|---|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 4 · 1 Point Worsening
|
2 Participants
|
6 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 2 · 4 Point Improvement
|
0 Participants
|
0 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 2 · 3 Point Improvement
|
0 Participants
|
0 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 2 · 2 Point Improvement
|
0 Participants
|
0 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 2 · 1 Point Improvement
|
1 Participants
|
1 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 2 · No Change
|
29 Participants
|
35 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 2 · 1 Point Worsening
|
2 Participants
|
3 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 2 · 2 Point Worsening
|
0 Participants
|
0 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 2 · 3 Point Worsening
|
0 Participants
|
1 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 2 · 4 Point Worsening
|
0 Participants
|
0 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 4 · 4 Point Improvement
|
0 Participants
|
0 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 4 · 3 Point Improvement
|
2 Participants
|
2 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 4 · 2 Point Improvement
|
2 Participants
|
6 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 4 · 1 Point Improvement
|
6 Participants
|
1 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 4 · No Change
|
19 Participants
|
23 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 4 · 2 Point Worsening
|
0 Participants
|
1 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 4 · 3 Point Worsening
|
1 Participants
|
1 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 4 · 4 Point Worsening
|
0 Participants
|
0 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 7 · 4 Point Improvement
|
0 Participants
|
0 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 7 · 3 Point Improvement
|
6 Participants
|
4 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 7 · 2 Point Improvement
|
11 Participants
|
17 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 7 · 1 Point Improvement
|
2 Participants
|
3 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 7 · No Change
|
8 Participants
|
10 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 7 · 1 Point Worsening
|
3 Participants
|
3 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 7 · 2 Point Worsening
|
0 Participants
|
1 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 7 · 3 Point Worsening
|
0 Participants
|
1 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 7 · 4 Point Worsening
|
0 Participants
|
0 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 11 · 4 Point Improvement
|
0 Participants
|
0 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 11 · 3 Point Improvement
|
5 Participants
|
5 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 11 · 2 Point Improvement
|
17 Participants
|
23 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 11 · 1 Point Improvement
|
3 Participants
|
1 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 11 · No Change
|
2 Participants
|
6 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 11 · 1 Point Worsening
|
3 Participants
|
1 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 11 · 2 Point Worsening
|
0 Participants
|
0 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 11 · 3 Point Worsening
|
0 Participants
|
1 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 11 · 4 Point Worsening
|
0 Participants
|
1 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 14 · 4 Point Improvement
|
0 Participants
|
0 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 14 · 3 Point Improvement
|
6 Participants
|
5 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 14 · 2 Point Improvement
|
18 Participants
|
23 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 14 · 1 Point Improvement
|
2 Participants
|
2 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 14 · No Change
|
2 Participants
|
5 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 14 · 1 Point Worsening
|
1 Participants
|
1 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 14 · 2 Point Worsening
|
0 Participants
|
0 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 14 · 3 Point Worsening
|
0 Participants
|
0 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 14 · 4 Point Worsening
|
0 Participants
|
0 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 21 · 4 Point Improvement
|
0 Participants
|
0 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 21 · 3 Point Improvement
|
7 Participants
|
9 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 21 · 2 Point Improvement
|
16 Participants
|
24 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 21 · 1 Point Improvement
|
3 Participants
|
1 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 21 · No Change
|
2 Participants
|
2 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 21 · 1 Point Worsening
|
1 Participants
|
0 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 21 · 2 Point Worsening
|
0 Participants
|
0 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 21 · 3 Point Worsening
|
0 Participants
|
0 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 21 · 4 Point Worsening
|
0 Participants
|
0 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 28 · 4 Point Improvement
|
0 Participants
|
0 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 28 · 3 Point Improvement
|
6 Participants
|
11 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 28 · 2 Point Improvement
|
20 Participants
|
23 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 28 · 1 Point Improvement
|
1 Participants
|
0 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 28 · No Change
|
2 Participants
|
1 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 28 · 1 Point Worsening
|
0 Participants
|
0 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 28 · 2 Point Worsening
|
0 Participants
|
0 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 28 · 3 Point Worsening
|
0 Participants
|
0 Participants
|
|
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Baseline to Day 28 · 4 Point Worsening
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up through 28 days.Population: All randomized participants were included in this analysis.
Number of Days until Initial Hospitalization Discharge or (NEWS2 \<= 2 Maintained for at Least 22 Hours) The National Early Warning Score 2 (NEWS2) score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters and ranges from 0 to 20. The NEWS2 is being used as an efficacy measure. Higher scores mean a worse outcome.
Outcome measures
| Measure |
Convalescent Plasma
n=35 Participants
The study intervention consists of intravenous administration of 200-500 mL of convalescent plasma administered in two equally divided doses, less than 12 hours apart.
Convalescent Plasma: Convalescent plasma from persons recovered from SARS-CoV-2 is being used to treat hospitalized individuals with complicated COVID-19 infection.
|
Masked Saline Placebo
n=40 Participants
The study intervention consists of intravenous administration of 200-500 mL of 0.9% saline administered in two equally divided doses, less than 12 hours apart.
Masked Saline Placebo: 0.9% saline solution will be used as the Masked Saline Placebo
|
|---|---|---|
|
Time to Discharge or to a National Early Warning Score 2 (NEWS2) of <= 2 Maintained for at Least 22 Hours, Whichever Occurs First
|
4 days
Interval 3.0 to 7.0
|
4.5 days
Interval 3.0 to 10.5
|
SECONDARY outcome
Timeframe: From Day 1 (baseline) to Days 2, 4, 7, 11, 15, and 29Population: This secondary outcome cannot be determined for 3 participants (3 in Convalescent Plasma, and 0 in Masked Saline Placebo) who terminated on the day of randomization.
Change in NEWS2 The National Early Warning Score 2 (NEWS2) has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters and ranges from 0 to 20. The NEWS2 is being used as an efficacy measure. Higher scores mean a worse outcome.
Outcome measures
| Measure |
Convalescent Plasma
n=32 Participants
The study intervention consists of intravenous administration of 200-500 mL of convalescent plasma administered in two equally divided doses, less than 12 hours apart.
Convalescent Plasma: Convalescent plasma from persons recovered from SARS-CoV-2 is being used to treat hospitalized individuals with complicated COVID-19 infection.
|
Masked Saline Placebo
n=40 Participants
The study intervention consists of intravenous administration of 200-500 mL of 0.9% saline administered in two equally divided doses, less than 12 hours apart.
Masked Saline Placebo: 0.9% saline solution will be used as the Masked Saline Placebo
|
|---|---|---|
|
Change in National Early Warning Score 2 (NEWS2) From Day 1 (Baseline) to Days 2, 4, 7, 11, 15, and 29
Day 1 to Day 2
|
0 score on a scale
Interval -0.5 to 1.0
|
0 score on a scale
Interval -1.0 to 1.0
|
|
Change in National Early Warning Score 2 (NEWS2) From Day 1 (Baseline) to Days 2, 4, 7, 11, 15, and 29
Day 1 to Day 4
|
-0.5 score on a scale
Interval -2.0 to 1.0
|
-1 score on a scale
Interval -2.0 to 1.0
|
|
Change in National Early Warning Score 2 (NEWS2) From Day 1 (Baseline) to Days 2, 4, 7, 11, 15, and 29
Day 1 to Day 7
|
-1 score on a scale
Interval -2.0 to 0.0
|
0 score on a scale
Interval -3.0 to 2.0
|
|
Change in National Early Warning Score 2 (NEWS2) From Day 1 (Baseline) to Days 2, 4, 7, 11, 15, and 29
Day 1 to Day 11
|
-2 score on a scale
Interval -3.0 to -0.5
|
-1 score on a scale
Interval -1.0 to 0.0
|
|
Change in National Early Warning Score 2 (NEWS2) From Day 1 (Baseline) to Days 2, 4, 7, 11, 15, and 29
Day 1 to Day 15
|
-2 score on a scale
Interval -3.0 to -1.0
|
-1.5 score on a scale
Interval -3.0 to -1.0
|
|
Change in National Early Warning Score 2 (NEWS2) From Day 1 (Baseline) to Days 2, 4, 7, 11, 15, and 29
Day 1 to Day 29
|
-2 score on a scale
Interval -3.0 to -2.0
|
-2 score on a scale
Interval -5.0 to -1.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 28Population: This secondary outcome cannot be determined for 3 participants (3 in Convalescent Plasma, and 0 in Masked Saline Placebo) who terminated early on the day of randomization.
Number of Days Hospitalized During Initial Hospitalization
Outcome measures
| Measure |
Convalescent Plasma
n=32 Participants
The study intervention consists of intravenous administration of 200-500 mL of convalescent plasma administered in two equally divided doses, less than 12 hours apart.
Convalescent Plasma: Convalescent plasma from persons recovered from SARS-CoV-2 is being used to treat hospitalized individuals with complicated COVID-19 infection.
|
Masked Saline Placebo
n=40 Participants
The study intervention consists of intravenous administration of 200-500 mL of 0.9% saline administered in two equally divided doses, less than 12 hours apart.
Masked Saline Placebo: 0.9% saline solution will be used as the Masked Saline Placebo
|
|---|---|---|
|
Duration of Hospitalization
|
5.5 days
Interval 4.0 to 8.5
|
6 days
Interval 4.0 to 10.5
|
SECONDARY outcome
Timeframe: Day 1 through Day 3Population: 3 participants in the Convalescent Plasma group withdrew from the study prior to study product administration.
Number of participants for whom study product administration was discontinued or temporarily suspended for any reason
Outcome measures
| Measure |
Convalescent Plasma
n=32 Participants
The study intervention consists of intravenous administration of 200-500 mL of convalescent plasma administered in two equally divided doses, less than 12 hours apart.
Convalescent Plasma: Convalescent plasma from persons recovered from SARS-CoV-2 is being used to treat hospitalized individuals with complicated COVID-19 infection.
|
Masked Saline Placebo
n=40 Participants
The study intervention consists of intravenous administration of 200-500 mL of 0.9% saline administered in two equally divided doses, less than 12 hours apart.
Masked Saline Placebo: 0.9% saline solution will be used as the Masked Saline Placebo
|
|---|---|---|
|
Incidence of Discontinuation or Temporary Suspension of Study Product Administrations (for Any Reason)
|
0 Participants
|
0 Participants
|
Adverse Events
Convalescent Plasma
Serious events: 8 serious events
Other events: 5 other events
Deaths: 3 deaths
Masked Saline Placebo
Serious events: 5 serious events
Other events: 9 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Convalescent Plasma
n=35 participants at risk
The study intervention consists of intravenous administration of 200-500 mL of convalescent plasma administered in two equally divided doses, less than 12 hours apart.
Convalescent Plasma: Convalescent plasma from persons recovered from SARS-CoV-2 is being used to treat hospitalized individuals with complicated COVID-19 infection.
|
Masked Saline Placebo
n=40 participants at risk
The study intervention consists of intravenous administration of 200-500 mL of 0.9% saline administered in two equally divided doses, less than 12 hours apart.
Masked Saline Placebo: 0.9% saline solution will be used as the Masked Saline Placebo
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/35 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
2.5%
1/40 • Number of events 1 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/35 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
2.5%
1/40 • Number of events 1 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
2.9%
1/35 • Number of events 1 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
0.00%
0/40 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
|
Infections and infestations
COVID-19 Pneumonia
|
2.9%
1/35 • Number of events 1 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
2.5%
1/40 • Number of events 1 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
|
Infections and infestations
Diabetic Foot Infection
|
2.9%
1/35 • Number of events 1 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
0.00%
0/40 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/35 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
2.5%
1/40 • Number of events 1 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
|
Infections and infestations
Urinary Tract Infection
|
2.9%
1/35 • Number of events 1 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
2.5%
1/40 • Number of events 1 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
|
Investigations
Electrocardiogram ST Segment Elevation
|
2.9%
1/35 • Number of events 1 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
0.00%
0/40 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
2.9%
1/35 • Number of events 1 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
0.00%
0/40 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/35 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
2.5%
1/40 • Number of events 1 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
2.9%
1/35 • Number of events 1 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
0.00%
0/40 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
11.4%
4/35 • Number of events 4 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
7.5%
3/40 • Number of events 3 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
Other adverse events
| Measure |
Convalescent Plasma
n=35 participants at risk
The study intervention consists of intravenous administration of 200-500 mL of convalescent plasma administered in two equally divided doses, less than 12 hours apart.
Convalescent Plasma: Convalescent plasma from persons recovered from SARS-CoV-2 is being used to treat hospitalized individuals with complicated COVID-19 infection.
|
Masked Saline Placebo
n=40 participants at risk
The study intervention consists of intravenous administration of 200-500 mL of 0.9% saline administered in two equally divided doses, less than 12 hours apart.
Masked Saline Placebo: 0.9% saline solution will be used as the Masked Saline Placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/35 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
2.5%
1/40 • Number of events 1 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
|
Investigations
Oxygen Consumption Increased
|
2.9%
1/35 • Number of events 1 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
10.0%
4/40 • Number of events 4 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.00%
0/35 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
2.5%
1/40 • Number of events 1 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/35 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
2.5%
1/40 • Number of events 1 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
2.9%
1/35 • Number of events 1 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
0.00%
0/40 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.9%
1/35 • Number of events 1 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
0.00%
0/40 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
|
Surgical and medical procedures
Intensive Care
|
2.9%
1/35 • Number of events 1 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
2.5%
1/40 • Number of events 1 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
|
Vascular disorders
Embolism
|
2.9%
1/35 • Number of events 1 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
2.5%
1/40 • Number of events 1 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
|
Vascular disorders
Hypertensive Urgency
|
0.00%
0/35 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
2.5%
1/40 • Number of events 1 • 28 days
The study requires reporting of the following types of events : 1. All serious adverse events, 2. Treatment-related adverse events at any severity, and 3. All grade 3 adverse events regardless of relatedness to study product.
|
Additional Information
Lisa Zehm, Project Manager
Palo Alto Cooperative Studies Program Coordinating Center
Phone: (650)493-5000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place