Trial Outcomes & Findings for Convalescent Plasma for Patients With COVID-19 (NCT NCT04385199)
NCT ID: NCT04385199
Last Updated: 2022-05-02
Results Overview
Change in oxygenation as documented by SaO2/FiO2 at 72 hours after infusion
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
day 3 post transfusion
Results posted on
2022-05-02
Participant Flow
Participant milestones
| Measure |
Convalescent Plasma Intervention
Convalescent plasma 200mL transfusion
Convalescent plasma: One 200mL transfusion of ABO compatible convalescent plasma over 3 hours
|
Standard Therapy Control
Standard therapy for COVID-19 disease as defined by institutional protocols
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
10
|
|
Overall Study
COMPLETED
|
19
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Convalescent Plasma Intervention
Convalescent plasma 200mL transfusion
Convalescent plasma: One 200mL transfusion of ABO compatible convalescent plasma over 3 hours
|
Standard Therapy Control
Standard therapy for COVID-19 disease as defined by institutional protocols
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Convalescent Plasma for Patients With COVID-19
Baseline characteristics by cohort
| Measure |
Convalescent Plasma Intervention
n=20 Participants
Convalescent plasma 200mL transfusion
Convalescent plasma: One 200mL transfusion of ABO compatible convalescent plasma over 3 hours
|
Standard Therapy Control
n=10 Participants
Standard therapy for COVID-19 disease as defined by institutional protocols
|
Total
n=30 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
|
5 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
|
Age, Continuous
|
56.6 years
STANDARD_DEVIATION 13.9 • n=39 Participants
|
53 years
STANDARD_DEVIATION 13.6 • n=41 Participants
|
55 years
STANDARD_DEVIATION 13 • n=35 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
6 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
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 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
|
13 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
8 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
|
4 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=39 Participants
|
10 participants
n=41 Participants
|
30 participants
n=35 Participants
|
|
Dyspnea with Respiratory Rate (RR) >30
|
9 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
|
SaO2/FiO2
|
188.4 ratio
STANDARD_DEVIATION 96.0 • n=39 Participants
|
196.5 ratio
STANDARD_DEVIATION 89.9 • n=41 Participants
|
190 ratio
STANDARD_DEVIATION 90 • n=35 Participants
|
|
Bilateral airspace opacities on CXR >50% within 24 to 48 hours
|
15 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
23 Participants
n=35 Participants
|
|
Mechanical ventilation
|
11 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: day 3 post transfusionChange in oxygenation as documented by SaO2/FiO2 at 72 hours after infusion
Outcome measures
| Measure |
Convalescent Plasma Intervention
n=20 Participants
Convalescent plasma 200mL transfusion
Convalescent plasma: One 200mL transfusion of ABO compatible convalescent plasma over 3 hours
|
Standard Therapy Control
n=10 Participants
Standard therapy for COVID-19 disease as defined by institutional protocols
|
|---|---|---|
|
Change in Respiratory Disease Severity
|
251 ratio
Standard Deviation 89
|
276 ratio
Standard Deviation 188
|
SECONDARY outcome
Timeframe: Up to 60 days At the end of the trial, if patients were still in the ICU, their date of transfer out of the ICU was collected and total ICU length of stay calculated.Total ICU length of stay
Outcome measures
| Measure |
Convalescent Plasma Intervention
n=20 Participants
Convalescent plasma 200mL transfusion
Convalescent plasma: One 200mL transfusion of ABO compatible convalescent plasma over 3 hours
|
Standard Therapy Control
n=10 Participants
Standard therapy for COVID-19 disease as defined by institutional protocols
|
|---|---|---|
|
ICU Length of Stay
|
19.5 days
Interval 10.0 to 46.0
|
13 days
Interval 10.0 to 19.0
|
SECONDARY outcome
Timeframe: Up to 60 days At the end of the trial, if patients were still in the hospital, their date of transfer out of the hospital was collected and hospital length of stay calculated.Hospital length of stay
Outcome measures
| Measure |
Convalescent Plasma Intervention
n=20 Participants
Convalescent plasma 200mL transfusion
Convalescent plasma: One 200mL transfusion of ABO compatible convalescent plasma over 3 hours
|
Standard Therapy Control
n=10 Participants
Standard therapy for COVID-19 disease as defined by institutional protocols
|
|---|---|---|
|
Length of Stay
|
20 days
Interval 7.5 to 46.0
|
11.5 days
Interval 9.0 to 18.0
|
SECONDARY outcome
Timeframe: 28 dayDuration of time on ventilator
Outcome measures
| Measure |
Convalescent Plasma Intervention
n=20 Participants
Convalescent plasma 200mL transfusion
Convalescent plasma: One 200mL transfusion of ABO compatible convalescent plasma over 3 hours
|
Standard Therapy Control
n=10 Participants
Standard therapy for COVID-19 disease as defined by institutional protocols
|
|---|---|---|
|
Ventilator Days
|
15.6 days
Interval 8.4 to 26.0
|
4.2 days
Interval 1.4 to 7.5
|
SECONDARY outcome
Timeframe: From transfusion up to 1 day post-transfusionAdverse transfusion events after 1 unit of convalescent plasma
Outcome measures
| Measure |
Convalescent Plasma Intervention
n=20 Participants
Convalescent plasma 200mL transfusion
Convalescent plasma: One 200mL transfusion of ABO compatible convalescent plasma over 3 hours
|
Standard Therapy Control
n=10 Participants
Standard therapy for COVID-19 disease as defined by institutional protocols
|
|---|---|---|
|
Number of Participants With Transfusion Adverse Events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Normal CXR at 28 days
Change in Chest X Ray Findings
Outcome measures
| Measure |
Convalescent Plasma Intervention
n=20 Participants
Convalescent plasma 200mL transfusion
Convalescent plasma: One 200mL transfusion of ABO compatible convalescent plasma over 3 hours
|
Standard Therapy Control
n=10 Participants
Standard therapy for COVID-19 disease as defined by institutional protocols
|
|---|---|---|
|
Normal Chest X Ray at 28 Days
|
9 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 28 daysAll-cause overall deaths at end of trial at 28 days
Outcome measures
| Measure |
Convalescent Plasma Intervention
n=20 Participants
Convalescent plasma 200mL transfusion
Convalescent plasma: One 200mL transfusion of ABO compatible convalescent plasma over 3 hours
|
Standard Therapy Control
n=10 Participants
Standard therapy for COVID-19 disease as defined by institutional protocols
|
|---|---|---|
|
All-cause Mortality
|
3 Participants
|
2 Participants
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place