Trial Outcomes & Findings for Effects of COVID-19 Convalescent Plasma (CCP) on Coronavirus-associated Complications in Hospitalized Patients (NCT NCT04421404)
NCT ID: NCT04421404
Last Updated: 2022-10-07
Results Overview
Number of participants that progressed to mechanical ventilation or death within the first 14 days of enrollment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
Day 14
Results posted on
2022-10-07
Participant Flow
Participant milestones
| Measure |
COVID-19 Convalescent Plasma
Subjects in the COVID-19 convalescent plasma group will receive a single infusion of 250 ml anti-SARS-CoV-2 convalescent fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.
COVID-19 Convalescent Plasma (CCP): COVID-19 Convalescent Plasma (CCP) is a form of passive antibody therapy that involves the administration of anti-SARS-CoV-2 antibodies to a susceptible individual for the purpose of preventing or treating the infectious disease it causes. Convalescent plasma for this trial will be obtained from Vitalant (or American Red Cross if necessary). Patients identified as having recovered from COVID-19 will serve as potential donors. Potential donors will be screened using an anti-SARS-CoV-2 serologic assay and antibody levels will be determined.
|
Placebo
Subjects in the placebo group will receive a single infusion of 250 ml of standard fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.
Placebo: Standard plasma will be obtained from Vitalant (or American Red Cross if necessary) and will be either collected prior to 12/1/2019 or tested and confirmed to be negative for anti-SARS-CoV-2.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
18
|
|
Overall Study
COMPLETED
|
16
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of COVID-19 Convalescent Plasma (CCP) on Coronavirus-associated Complications in Hospitalized Patients
Baseline characteristics by cohort
| Measure |
COVID-19 Convalescent Plasma
n=16 Participants
Subjects in the COVID-19 convalescent plasma group will receive a single infusion of 250 ml anti-SARS-CoV-2 convalescent fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.
COVID-19 Convalescent Plasma (CCP): COVID-19 Convalescent Plasma (CCP) is a form of passive antibody therapy that involves the administration of anti-SARS-CoV-2 antibodies to a susceptible individual for the purpose of preventing or treating the infectious disease it causes. Convalescent plasma for this trial will be obtained from Vitalant (or American Red Cross if necessary). Patients identified as having recovered from COVID-19 will serve as potential donors. Potential donors will be screened using an anti-SARS-CoV-2 serologic assay and antibody levels will be determined.
|
Placebo
n=18 Participants
Subjects in the placebo group will receive a single infusion of 250 ml of standard fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.
Placebo: Standard plasma will be obtained from Vitalant (or American Red Cross if necessary) and will be either collected prior to 12/1/2019 or tested and confirmed to be negative for anti-SARS-CoV-2.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
n=5 Participants
|
62 years
n=7 Participants
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 14Number of participants that progressed to mechanical ventilation or death within the first 14 days of enrollment.
Outcome measures
| Measure |
COVID-19 Convalescent Plasma
n=16 Participants
Subjects in the COVID-19 convalescent plasma group will receive a single infusion of 250 ml anti-SARS-CoV-2 convalescent fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.
COVID-19 Convalescent Plasma (CCP): COVID-19 Convalescent Plasma (CCP) is a form of passive antibody therapy that involves the administration of anti-SARS-CoV-2 antibodies to a susceptible individual for the purpose of preventing or treating the infectious disease it causes. Convalescent plasma for this trial will be obtained from Vitalant (or American Red Cross if necessary). Patients identified as having recovered from COVID-19 will serve as potential donors. Potential donors will be screened using an anti-SARS-CoV-2 serologic assay and antibody levels will be determined.
|
Placebo
n=18 Participants
Subjects in the placebo group will receive a single infusion of 250 ml of standard fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.
Placebo: Standard plasma will be obtained from Vitalant (or American Red Cross if necessary) and will be either collected prior to 12/1/2019 or tested and confirmed to be negative for anti-SARS-CoV-2.
|
|---|---|---|
|
Mechanical Ventilation or Death Endpoint
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 28Progression to mechanical ventilation or death within the first 28 days of enrollment.
Outcome measures
| Measure |
COVID-19 Convalescent Plasma
n=16 Participants
Subjects in the COVID-19 convalescent plasma group will receive a single infusion of 250 ml anti-SARS-CoV-2 convalescent fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.
COVID-19 Convalescent Plasma (CCP): COVID-19 Convalescent Plasma (CCP) is a form of passive antibody therapy that involves the administration of anti-SARS-CoV-2 antibodies to a susceptible individual for the purpose of preventing or treating the infectious disease it causes. Convalescent plasma for this trial will be obtained from Vitalant (or American Red Cross if necessary). Patients identified as having recovered from COVID-19 will serve as potential donors. Potential donors will be screened using an anti-SARS-CoV-2 serologic assay and antibody levels will be determined.
|
Placebo
n=18 Participants
Subjects in the placebo group will receive a single infusion of 250 ml of standard fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.
Placebo: Standard plasma will be obtained from Vitalant (or American Red Cross if necessary) and will be either collected prior to 12/1/2019 or tested and confirmed to be negative for anti-SARS-CoV-2.
|
|---|---|---|
|
Mechanical Ventilation or Death Endpoint
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 29Population: The number of participants in the table below differs, as these are the number of participants per visit day. The number of participants decreased over the visit days as there was loss to follow up.
Clinical efficacy of CCP relative to the control arm in adults hospitalized with COVID-19 according to clinical status as assessed by 8-point ordinal scale. 8 Point WHO Ordinal Scale of Clinical Status: Uninfected (No clinical or virological evidence of infection) - 0 Ambulatory (No limitation of activities) - 1 Ambulatory (Limitation of Activities) - 2 Hospitalized Mild Disease (Hospitalized, no oxygen therapy) - 3 Hospitalized Mild Disease (Oxygen by mask or nasal prongs) - 4 Hospitalized Severe Disease (Non-invasive ventilation or high flow oxygen) - 5 Hospitalized Severe Disease (Intubation and mechanical ventilation) - 6 Hospitalized Severe Disease (Ventilation + Additional organ support (pressors, RRT, ECMO)) - 7 Dead (Death) - 8
Outcome measures
| Measure |
COVID-19 Convalescent Plasma
n=14 Participants
Subjects in the COVID-19 convalescent plasma group will receive a single infusion of 250 ml anti-SARS-CoV-2 convalescent fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.
COVID-19 Convalescent Plasma (CCP): COVID-19 Convalescent Plasma (CCP) is a form of passive antibody therapy that involves the administration of anti-SARS-CoV-2 antibodies to a susceptible individual for the purpose of preventing or treating the infectious disease it causes. Convalescent plasma for this trial will be obtained from Vitalant (or American Red Cross if necessary). Patients identified as having recovered from COVID-19 will serve as potential donors. Potential donors will be screened using an anti-SARS-CoV-2 serologic assay and antibody levels will be determined.
|
Placebo
n=15 Participants
Subjects in the placebo group will receive a single infusion of 250 ml of standard fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.
Placebo: Standard plasma will be obtained from Vitalant (or American Red Cross if necessary) and will be either collected prior to 12/1/2019 or tested and confirmed to be negative for anti-SARS-CoV-2.
|
|---|---|---|
|
8-Point Ordinal Scale Endpoint
Day 1
|
2.43 score on a scale
Interval 1.0 to 4.0
|
1.93 score on a scale
Interval 1.0 to 3.0
|
|
8-Point Ordinal Scale Endpoint
Day 2
|
2.15 score on a scale
Interval 1.0 to 4.0
|
2.14 score on a scale
Interval 1.0 to 3.75
|
|
8-Point Ordinal Scale Endpoint
Day 3
|
3.92 score on a scale
Interval 3.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
8-Point Ordinal Scale Endpoint
Day 4
|
3.42 score on a scale
Interval 3.0 to 4.0
|
3.69 score on a scale
Interval 3.5 to 4.0
|
|
8-Point Ordinal Scale Endpoint
Day 5
|
2.83 score on a scale
Interval 1.0 to 4.0
|
2.92 score on a scale
Interval 2.5 to 4.0
|
|
8-Point Ordinal Scale Endpoint
Day 6
|
2.18 score on a scale
Interval 0.5 to 3.5
|
2.45 score on a scale
Interval 0.0 to 4.0
|
|
8-Point Ordinal Scale Endpoint
Day 7
|
3.4 score on a scale
Interval 1.0 to 5.0
|
3.5 score on a scale
Interval 3.0 to 4.0
|
|
8-Point Ordinal Scale Endpoint
Day 8
|
5 score on a scale
Interval 4.5 to 5.5
|
2.57 score on a scale
Interval 2.0 to 3.5
|
|
8-Point Ordinal Scale Endpoint
Day 9
|
4.67 score on a scale
Interval 4.0 to 5.5
|
1.86 score on a scale
Interval 0.5 to 3.0
|
|
8-Point Ordinal Scale Endpoint
Day 10
|
3.67 score on a scale
Interval 2.5 to 5.5
|
1.8 score on a scale
Interval 0.0 to 3.0
|
|
8-Point Ordinal Scale Endpoint
Day 11
|
5 score on a scale
Interval 4.5 to 5.5
|
2.5 score on a scale
Interval 2.25 to 2.75
|
|
8-Point Ordinal Scale Endpoint
Day 12
|
5 score on a scale
Interval 4.5 to 5.5
|
2 score on a scale
Interval 1.5 to 2.5
|
|
8-Point Ordinal Scale Endpoint
Day 13
|
3 score on a scale
Interval 1.5 to 4.5
|
2.5 score on a scale
Interval 2.25 to 2.75
|
|
8-Point Ordinal Scale Endpoint
Day 14
|
2 score on a scale
Interval 0.0 to 3.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
8-Point Ordinal Scale Endpoint
Day 15
|
6 score on a scale
Interval 6.0 to 6.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
8-Point Ordinal Scale Endpoint
Day 16
|
6 score on a scale
Interval 6.0 to 6.0
|
8 score on a scale
Interval 8.0 to 8.0
|
|
8-Point Ordinal Scale Endpoint
Day 17
|
6 score on a scale
Interval 6.0 to 6.0
|
8 score on a scale
Interval 8.0 to 8.0
|
|
8-Point Ordinal Scale Endpoint
Day 18
|
6 score on a scale
Interval 6.0 to 6.0
|
8 score on a scale
Interval 8.0 to 8.0
|
|
8-Point Ordinal Scale Endpoint
Day 19
|
6 score on a scale
Interval 6.0 to 6.0
|
—
|
|
8-Point Ordinal Scale Endpoint
Day 20
|
6 score on a scale
Interval 6.0 to 6.0
|
—
|
|
8-Point Ordinal Scale Endpoint
Day 22
|
8 score on a scale
Interval 8.0 to 8.0
|
—
|
|
8-Point Ordinal Scale Endpoint
Day 29
|
—
|
0 score on a scale
Interval 0.0 to 0.0
|
|
8-Point Ordinal Scale Endpoint
Day 21
|
8 score on a scale
Interval 8.0 to 8.0
|
—
|
Adverse Events
COVID-19 Convalescent Plasma
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
Placebo
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
COVID-19 Convalescent Plasma
n=16 participants at risk
Subjects in the COVID-19 convalescent plasma group will receive a single infusion of 250 ml anti-SARS-CoV-2 convalescent fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.
COVID-19 Convalescent Plasma (CCP): COVID-19 Convalescent Plasma (CCP) is a form of passive antibody therapy that involves the administration of anti-SARS-CoV-2 antibodies to a susceptible individual for the purpose of preventing or treating the infectious disease it causes. Convalescent plasma for this trial will be obtained from Vitalant (or American Red Cross if necessary). Patients identified as having recovered from COVID-19 will serve as potential donors. Potential donors will be screened using an anti-SARS-CoV-2 serologic assay and antibody levels will be determined.
|
Placebo
n=18 participants at risk
Subjects in the placebo group will receive a single infusion of 250 ml of standard fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.
Placebo: Standard plasma will be obtained from Vitalant (or American Red Cross if necessary) and will be either collected prior to 12/1/2019 or tested and confirmed to be negative for anti-SARS-CoV-2.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Intubation
|
12.5%
2/16 • 90 days
|
0.00%
0/18 • 90 days
|
|
General disorders
Death
|
6.2%
1/16 • 90 days
|
5.6%
1/18 • 90 days
|
Other adverse events
| Measure |
COVID-19 Convalescent Plasma
n=16 participants at risk
Subjects in the COVID-19 convalescent plasma group will receive a single infusion of 250 ml anti-SARS-CoV-2 convalescent fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.
COVID-19 Convalescent Plasma (CCP): COVID-19 Convalescent Plasma (CCP) is a form of passive antibody therapy that involves the administration of anti-SARS-CoV-2 antibodies to a susceptible individual for the purpose of preventing or treating the infectious disease it causes. Convalescent plasma for this trial will be obtained from Vitalant (or American Red Cross if necessary). Patients identified as having recovered from COVID-19 will serve as potential donors. Potential donors will be screened using an anti-SARS-CoV-2 serologic assay and antibody levels will be determined.
|
Placebo
n=18 participants at risk
Subjects in the placebo group will receive a single infusion of 250 ml of standard fresh frozen plasma, ABO compatible with the patient, within 24 hours of randomization.
Placebo: Standard plasma will be obtained from Vitalant (or American Red Cross if necessary) and will be either collected prior to 12/1/2019 or tested and confirmed to be negative for anti-SARS-CoV-2.
|
|---|---|---|
|
Cardiac disorders
Hypotension (transfusion reaction)
|
0.00%
0/16 • 90 days
|
5.6%
1/18 • 90 days
|
|
Hepatobiliary disorders
Elevated LFTs
|
6.2%
1/16 • 90 days
|
0.00%
0/18 • 90 days
|
|
Infections and infestations
UTI
|
6.2%
1/16 • 90 days
|
0.00%
0/18 • 90 days
|
|
Endocrine disorders
Elevated triglycerides
|
6.2%
1/16 • 90 days
|
0.00%
0/18 • 90 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place