Trial Outcomes & Findings for Convalescent Plasma for Early Treatment of COVID-19 (NCT NCT04390503)
NCT ID: NCT04390503
Last Updated: 2024-08-28
Results Overview
Participants who were discharged from the hospital after receiving the study intervention.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
223 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2024-08-28
Participant Flow
Participant milestones
| Measure |
Experimental Arm: Convalescent Plasma
Participants will receive 2 units (approximately 200 to 250 mL per unit, total 400-500mL) of convalescent plasma that was collected from a volunteer who recovered from COVID-19 disease.
|
Control Arm: Albumin 5%
Participants will receive 2 units of 250 mL (500mL total) of human albumin 5% infusion. Albumin 5% is a sterile aqueous solution for intravenous use containing the albumin component human plasma. The albumin will be prepared in bags that are identical to the bags used for plasma. The similar appearance of albumin and plasma will facilitate maintaining the blinded status of subjects and most of the study staff.
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
73
|
|
Overall Study
COMPLETED
|
147
|
72
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Experimental Arm: Convalescent Plasma
Participants will receive 2 units (approximately 200 to 250 mL per unit, total 400-500mL) of convalescent plasma that was collected from a volunteer who recovered from COVID-19 disease.
|
Control Arm: Albumin 5%
Participants will receive 2 units of 250 mL (500mL total) of human albumin 5% infusion. Albumin 5% is a sterile aqueous solution for intravenous use containing the albumin component human plasma. The albumin will be prepared in bags that are identical to the bags used for plasma. The similar appearance of albumin and plasma will facilitate maintaining the blinded status of subjects and most of the study staff.
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental Arm: Convalescent Plasma
n=150 Participants
Participants will receive 2 units (approximately 200 to 250 mL per unit, total 400-500mL) of convalescent plasma that was collected from a volunteer who recovered from COVID-19 disease.
|
Control Arm: Albumin 5%
n=73 Participants
Participants will receive 2 units of 250 mL (500mL total) of human albumin 5% infusion. Albumin 5% is a sterile aqueous solution for intravenous use containing the albumin component human plasma. The albumin will be prepared in bags that are identical to the bags used for plasma. The similar appearance of albumin and plasma will facilitate maintaining the blinded status of subjects and most of the study staff.
|
Total
n=223 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<60 years
|
74 Participants
n=150 Participants
|
28 Participants
n=73 Participants
|
102 Participants
n=223 Participants
|
|
Age, Customized
60-69 years
|
35 Participants
n=150 Participants
|
24 Participants
n=73 Participants
|
59 Participants
n=223 Participants
|
|
Age, Customized
70-79 years
|
28 Participants
n=150 Participants
|
16 Participants
n=73 Participants
|
44 Participants
n=223 Participants
|
|
Age, Customized
≥80 years
|
13 Participants
n=150 Participants
|
5 Participants
n=73 Participants
|
18 Participants
n=223 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=150 Participants
|
51 Participants
n=73 Participants
|
147 Participants
n=223 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=150 Participants
|
22 Participants
n=73 Participants
|
76 Participants
n=223 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Brazil
|
101 participants
n=150 Participants
|
49 participants
n=73 Participants
|
150 participants
n=223 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=150 Participants
|
24 participants
n=73 Participants
|
73 participants
n=223 Participants
|
|
Clinical status at randomization
Hospitalized, not requiring supplemental oxygen
|
5 Participants
n=150 Participants
|
5 Participants
n=73 Participants
|
10 Participants
n=223 Participants
|
|
Clinical status at randomization
Hospitalized, requiring supplemental oxygen, HFO, NIV
|
125 Participants
n=150 Participants
|
57 Participants
n=73 Participants
|
182 Participants
n=223 Participants
|
|
Clinical status at randomization
Hospitalized, requiring IMV, ECMO, or both
|
17 Participants
n=150 Participants
|
11 Participants
n=73 Participants
|
28 Participants
n=223 Participants
|
|
Baseline conditions
COVID-19
|
150 Participants
n=150 Participants
|
73 Participants
n=73 Participants
|
223 Participants
n=223 Participants
|
|
Baseline conditions
Hypertension
|
53 Participants
n=150 Participants
|
22 Participants
n=73 Participants
|
75 Participants
n=223 Participants
|
|
Baseline conditions
Diabetes mellitus
|
55 Participants
n=150 Participants
|
27 Participants
n=73 Participants
|
82 Participants
n=223 Participants
|
|
Baseline conditions
Hyperlipidemia
|
27 Participants
n=150 Participants
|
9 Participants
n=73 Participants
|
36 Participants
n=223 Participants
|
|
Baseline conditions
Chronic cardiac disease
|
56 Participants
n=150 Participants
|
28 Participants
n=73 Participants
|
84 Participants
n=223 Participants
|
|
Baseline conditions
Chronic kidney disease
|
13 Participants
n=150 Participants
|
8 Participants
n=73 Participants
|
21 Participants
n=223 Participants
|
|
Baseline conditions
Chronic pulmonary disease
|
15 Participants
n=150 Participants
|
5 Participants
n=73 Participants
|
20 Participants
n=223 Participants
|
|
Baseline conditions
Chronic liver disease
|
3 Participants
n=150 Participants
|
1 Participants
n=73 Participants
|
4 Participants
n=223 Participants
|
|
Baseline conditions
HIV
|
4 Participants
n=150 Participants
|
0 Participants
n=73 Participants
|
4 Participants
n=223 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysParticipants who were discharged from the hospital after receiving the study intervention.
Outcome measures
| Measure |
Experimental Arm: Convalescent Plasma
n=150 Participants
Participants will receive 2 units (approximately 200 to 250 mL per unit, total 400-500mL) of convalescent plasma that was collected from a volunteer who recovered from COVID-19 disease.
|
Control Arm: Albumin 5%
n=73 Participants
Participants will receive 2 units of 250 mL (500mL total) of human albumin 5% infusion. Albumin 5% is a sterile aqueous solution for intravenous use containing the albumin component human plasma. The albumin will be prepared in bags that are identical to the bags used for plasma. The similar appearance of albumin and plasma will facilitate maintaining the blinded status of subjects and most of the study staff.
|
|---|---|---|
|
Number of Non-Hospitalized Participants
|
108 Participants
|
48 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: Only includes individuals who have data at day 28.
Participants who remained hospitalized and required supplemental oxygen after receiving the study drug.
Outcome measures
| Measure |
Experimental Arm: Convalescent Plasma
n=42 Participants
Participants will receive 2 units (approximately 200 to 250 mL per unit, total 400-500mL) of convalescent plasma that was collected from a volunteer who recovered from COVID-19 disease.
|
Control Arm: Albumin 5%
n=25 Participants
Participants will receive 2 units of 250 mL (500mL total) of human albumin 5% infusion. Albumin 5% is a sterile aqueous solution for intravenous use containing the albumin component human plasma. The albumin will be prepared in bags that are identical to the bags used for plasma. The similar appearance of albumin and plasma will facilitate maintaining the blinded status of subjects and most of the study staff.
|
|---|---|---|
|
Number of Hospitalized Participants Requiring Supplemental Oxygen
|
7 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: Only includes individuals who have data at day 28.
Participants who remained hospitalized and required high-flow oxygen therapy or noninvasive mechanical ventilation after receiving the study intervention.
Outcome measures
| Measure |
Experimental Arm: Convalescent Plasma
n=42 Participants
Participants will receive 2 units (approximately 200 to 250 mL per unit, total 400-500mL) of convalescent plasma that was collected from a volunteer who recovered from COVID-19 disease.
|
Control Arm: Albumin 5%
n=25 Participants
Participants will receive 2 units of 250 mL (500mL total) of human albumin 5% infusion. Albumin 5% is a sterile aqueous solution for intravenous use containing the albumin component human plasma. The albumin will be prepared in bags that are identical to the bags used for plasma. The similar appearance of albumin and plasma will facilitate maintaining the blinded status of subjects and most of the study staff.
|
|---|---|---|
|
Number of Hospitalized Participants Requiring High-flow Oxygen Therapy or Noninvasive Mechanical Ventilation
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysParticipants who died in the hospital after receiving the study drug.
Outcome measures
| Measure |
Experimental Arm: Convalescent Plasma
n=150 Participants
Participants will receive 2 units (approximately 200 to 250 mL per unit, total 400-500mL) of convalescent plasma that was collected from a volunteer who recovered from COVID-19 disease.
|
Control Arm: Albumin 5%
n=73 Participants
Participants will receive 2 units of 250 mL (500mL total) of human albumin 5% infusion. Albumin 5% is a sterile aqueous solution for intravenous use containing the albumin component human plasma. The albumin will be prepared in bags that are identical to the bags used for plasma. The similar appearance of albumin and plasma will facilitate maintaining the blinded status of subjects and most of the study staff.
|
|---|---|---|
|
Number of In-hospital Mortalities
|
19 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Up to 90 daysPopulation: These samples were not collected for analysis.
To compare the rate of measurable anti-SARS-CoV-2 titers between recipients of CP (anti-SARS-CoV-2 plasma) versus control (albumin 5%).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: These samples were not collected for analysis.
Compare the rates of SARS-CoV-2 PCR positivity (RT PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (albumin 5%).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Data was not collected for this outcome measure.
Compare the duration of SARS-CoV-2 PCR positivity (RT PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (albumin 5%).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Samples were not collected for analysis.
Compare the levels of SARS-CoV-2 RNA between the recipients of antiSARS-CoV-2 plasma and control (albumin 5%)
Outcome measures
Outcome data not reported
Adverse Events
Experimental Arm: Convalescent Plasma
Serious events: 39 serious events
Other events: 38 other events
Deaths: 19 deaths
Control Arm: Albumin 5%
Serious events: 26 serious events
Other events: 17 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Experimental Arm: Convalescent Plasma
n=147 participants at risk
Participants will receive 2 units (approximately 200 to 250 mL per unit, total 400-500mL) of convalescent plasma that was collected from a volunteer who recovered from COVID-19 disease.
|
Control Arm: Albumin 5%
n=72 participants at risk
Participants will receive 2 units of 250 mL (500mL total) of human albumin 5% infusion. Albumin 5% is a sterile aqueous solution for intravenous use containing the albumin component human plasma. The albumin will be prepared in bags that are identical to the bags used for plasma. The similar appearance of albumin and plasma will facilitate maintaining the blinded status of subjects and most of the study staff.
|
|---|---|---|
|
Blood and lymphatic system disorders
arterial thrombosis
|
0.00%
0/147 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
1.4%
1/72 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
|
Blood and lymphatic system disorders
disseminated intravascular coagulation
|
0.68%
1/147 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
0.00%
0/72 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
|
Blood and lymphatic system disorders
pulmonary embolism
|
1.4%
2/147 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
0.00%
0/72 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
|
Blood and lymphatic system disorders
venous thrombosis
|
2.7%
4/147 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
2.8%
2/72 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
|
Cardiac disorders
arrhythmia
|
6.8%
10/147 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
6.9%
5/72 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
|
Cardiac disorders
cardiac arrest
|
0.68%
1/147 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
4.2%
3/72 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
|
Cardiac disorders
cardiogenic shock
|
0.00%
0/147 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
1.4%
1/72 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
|
Cardiac disorders
myocarditis
|
0.68%
1/147 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
0.00%
0/72 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
|
Cardiac disorders
septic shock
|
2.7%
4/147 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
5.6%
4/72 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
|
Gastrointestinal disorders
pneumoperitoneum
|
0.68%
1/147 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
0.00%
0/72 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
|
Immune system disorders
hypothermia
|
0.00%
0/147 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
1.4%
1/72 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
|
Infections and infestations
ventilator-associated pneumonia
|
1.4%
2/147 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
2.8%
2/72 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
|
Renal and urinary disorders
ketoacidosis
|
0.68%
1/147 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
0.00%
0/72 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
|
Renal and urinary disorders
metabolic acidosis
|
0.00%
0/147 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
1.4%
1/72 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory failure
|
16.3%
24/147 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
22.2%
16/72 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
Other adverse events
| Measure |
Experimental Arm: Convalescent Plasma
n=147 participants at risk
Participants will receive 2 units (approximately 200 to 250 mL per unit, total 400-500mL) of convalescent plasma that was collected from a volunteer who recovered from COVID-19 disease.
|
Control Arm: Albumin 5%
n=72 participants at risk
Participants will receive 2 units of 250 mL (500mL total) of human albumin 5% infusion. Albumin 5% is a sterile aqueous solution for intravenous use containing the albumin component human plasma. The albumin will be prepared in bags that are identical to the bags used for plasma. The similar appearance of albumin and plasma will facilitate maintaining the blinded status of subjects and most of the study staff.
|
|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
6.1%
9/147 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
4.2%
3/72 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
|
Infections and infestations
Pneumonia
|
10.9%
16/147 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
9.7%
7/72 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
|
Cardiac disorders
hypotension
|
5.4%
8/147 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
8.3%
6/72 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
|
Blood and lymphatic system disorders
anemia
|
8.2%
12/147 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
9.7%
7/72 • Collected from baseline until day 28.
Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place