Trial Outcomes & Findings for Plasma Therapy of COVID-19 in Severely Ill Patients (NCT NCT04359810)
NCT ID: NCT04359810
Last Updated: 2024-09-19
Results Overview
Compare the day 28 severity outcome amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups using a 7-point ordinal scale of clinical status. Seven-point ordinal scale for clinical assessment ranges from 1 and 2: Not hospitalized 3: Hospitalized, not requiring supplemental oxygen 4: Hospitalized, requiring supplemental oxygen 5: Hospitalized, requiring high-flow oxygen therapy or noninvasive mechanical ventilation 6: Hospitalized, requiring IMV, ECMO, or both 7: Dead Higher number means worse outcome
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
223 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Convalescent Plasma (Anti-SARS-CoV-2 Plasma)
Convalescent plasma (1 unit; \~200-250 mL) collected from a volunteer who recovered from COVID-19 disease
Convalescent Plasma (anti-SARS-CoV-2 plasma): Convalescent Plasma that contains antibody titers against SARS-CoV-2
|
Non-convalescent Plasma (Control Plasma)
Non-convalescent plasma (1 unit; \~200-250 mL) of standard plasma collected prior to December 2019
Non-convalescent Plasma (control plasma): Non-convalescent plasma (does not contain antibody titers against SARS-CoV-2)
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
73
|
|
Overall Study
COMPLETED
|
150
|
73
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Convalescent Plasma (Anti-SARS-CoV-2 Plasma)
n=150 Participants
Convalescent plasma (1 unit; \~200-250 mL) collected from a volunteer who recovered from COVID-19 disease
Convalescent Plasma (anti-SARS-CoV-2 plasma): Convalescent Plasma that contains antibody titers against SARS-CoV-2
|
Non-convalescent Plasma (Control Plasma)
n=73 Participants
Non-convalescent plasma (1 unit; \~200-250 mL) of standard plasma collected prior to December 2019
Non-convalescent Plasma (control plasma): Non-convalescent plasma (does not contain antibody titers against SARS-CoV-2)
|
Total
n=223 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 60 years old
|
74 Participants
n=150 Participants
|
28 Participants
n=73 Participants
|
102 Participants
n=223 Participants
|
|
Age, Customized
60 - 69 years old
|
35 Participants
n=150 Participants
|
24 Participants
n=73 Participants
|
59 Participants
n=223 Participants
|
|
Age, Customized
70 - 79 years old
|
28 Participants
n=150 Participants
|
16 Participants
n=73 Participants
|
44 Participants
n=223 Participants
|
|
Age, Customized
>= 80 years old
|
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
United States
|
49 participants
n=150 Participants
|
24 participants
n=73 Participants
|
73 participants
n=223 Participants
|
|
Region of Enrollment
Brazil
|
101 participants
n=150 Participants
|
49 participants
n=73 Participants
|
150 participants
n=223 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysCompare the day 28 severity outcome amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups using a 7-point ordinal scale of clinical status. Seven-point ordinal scale for clinical assessment ranges from 1 and 2: Not hospitalized 3: Hospitalized, not requiring supplemental oxygen 4: Hospitalized, requiring supplemental oxygen 5: Hospitalized, requiring high-flow oxygen therapy or noninvasive mechanical ventilation 6: Hospitalized, requiring IMV, ECMO, or both 7: Dead Higher number means worse outcome
Outcome measures
| Measure |
Convalescent Plasma (Anti-SARS-CoV-2 Plasma)
n=150 Participants
Convalescent plasma (1 unit; \~200-250 mL) collected from a volunteer who recovered from COVID-19 disease
Convalescent Plasma (anti-SARS-CoV-2 plasma): Convalescent Plasma that contains antibody titers against SARS-CoV-2
|
Non-convalescent Plasma (Control Plasma)
n=73 Participants
Non-convalescent plasma (1 unit; \~200-250 mL) of standard plasma collected prior to December 2019
Non-convalescent Plasma (control plasma): Non-convalescent plasma (does not contain antibody titers against SARS-CoV-2)
|
|---|---|---|
|
Number of Participants With Day 28 Severity Outcomes Using a 7-point Ordinal Scale of Clinical Status
Not hospitalized
|
108 Participants
|
48 Participants
|
|
Number of Participants With Day 28 Severity Outcomes Using a 7-point Ordinal Scale of Clinical Status
Hospitalized, not requiring supplemental oxygen
|
3 Participants
|
2 Participants
|
|
Number of Participants With Day 28 Severity Outcomes Using a 7-point Ordinal Scale of Clinical Status
Hospitalized, requiring supplemental oxygen
|
7 Participants
|
1 Participants
|
|
Number of Participants With Day 28 Severity Outcomes Using a 7-point Ordinal Scale of Clinical Status
Hospitalized, requiring high-flow oxygen therapy or noninvasive mechanical ventilation
|
1 Participants
|
0 Participants
|
|
Number of Participants With Day 28 Severity Outcomes Using a 7-point Ordinal Scale of Clinical Status
Hospitalized, requiring IMV, ECMO, or both
|
12 Participants
|
4 Participants
|
|
Number of Participants With Day 28 Severity Outcomes Using a 7-point Ordinal Scale of Clinical Status
Dead
|
19 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Up to 14 daysPopulation: Data was not collected or analyzed.
Compare the proportion and duration of SARS-CoV-2 PCR positivity (via RT-PCR) amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups at days 0, 7, and 14.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 14 daysPopulation: Data was not collected or analyzed.
Compare levels of SARS-CoV-2 RNA amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups at days 0, 7, and 14.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 28 daysCompare duration of need for supplemental oxygen and/or mechanical ventilation amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups.
Outcome measures
| Measure |
Convalescent Plasma (Anti-SARS-CoV-2 Plasma)
n=20 Participants
Convalescent plasma (1 unit; \~200-250 mL) collected from a volunteer who recovered from COVID-19 disease
Convalescent Plasma (anti-SARS-CoV-2 plasma): Convalescent Plasma that contains antibody titers against SARS-CoV-2
|
Non-convalescent Plasma (Control Plasma)
n=5 Participants
Non-convalescent plasma (1 unit; \~200-250 mL) of standard plasma collected prior to December 2019
Non-convalescent Plasma (control plasma): Non-convalescent plasma (does not contain antibody titers against SARS-CoV-2)
|
|---|---|---|
|
Duration of Need for Supplemental Oxygen
|
6 days
Interval 3.0 to 16.0
|
7 days
Interval 3.0 to 11.0
|
SECONDARY outcome
Timeframe: Up to 28 daysCompare duration of hospitalization amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups.
Outcome measures
| Measure |
Convalescent Plasma (Anti-SARS-CoV-2 Plasma)
n=23 Participants
Convalescent plasma (1 unit; \~200-250 mL) collected from a volunteer who recovered from COVID-19 disease
Convalescent Plasma (anti-SARS-CoV-2 plasma): Convalescent Plasma that contains antibody titers against SARS-CoV-2
|
Non-convalescent Plasma (Control Plasma)
n=7 Participants
Non-convalescent plasma (1 unit; \~200-250 mL) of standard plasma collected prior to December 2019
Non-convalescent Plasma (control plasma): Non-convalescent plasma (does not contain antibody titers against SARS-CoV-2)
|
|---|---|---|
|
Duration of Hospitalization
|
9 days
Interval 6.0 to 28.0
|
8 days
Interval 6.0 to 22.0
|
SECONDARY outcome
Timeframe: Up to 28 daysCompare up to 28-day mortality amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups.
Outcome measures
| Measure |
Convalescent Plasma (Anti-SARS-CoV-2 Plasma)
n=150 Participants
Convalescent plasma (1 unit; \~200-250 mL) collected from a volunteer who recovered from COVID-19 disease
Convalescent Plasma (anti-SARS-CoV-2 plasma): Convalescent Plasma that contains antibody titers against SARS-CoV-2
|
Non-convalescent Plasma (Control Plasma)
n=73 Participants
Non-convalescent plasma (1 unit; \~200-250 mL) of standard plasma collected prior to December 2019
Non-convalescent Plasma (control plasma): Non-convalescent plasma (does not contain antibody titers against SARS-CoV-2)
|
|---|---|---|
|
28-day Mortality
|
19 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysCompare time-to-clinical improvement in-hospital amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups, defined as the time to either an improvement of clinical status or alive discharge from the hospital, whichever comes first.
Outcome measures
| Measure |
Convalescent Plasma (Anti-SARS-CoV-2 Plasma)
n=150 Participants
Convalescent plasma (1 unit; \~200-250 mL) collected from a volunteer who recovered from COVID-19 disease
Convalescent Plasma (anti-SARS-CoV-2 plasma): Convalescent Plasma that contains antibody titers against SARS-CoV-2
|
Non-convalescent Plasma (Control Plasma)
n=73 Participants
Non-convalescent plasma (1 unit; \~200-250 mL) of standard plasma collected prior to December 2019
Non-convalescent Plasma (control plasma): Non-convalescent plasma (does not contain antibody titers against SARS-CoV-2)
|
|---|---|---|
|
Time-to-clinical Improvement In-hospital
|
5 days
Interval 4.0 to 6.0
|
7 days
Interval 5.0 to 8.0
|
SECONDARY outcome
Timeframe: Day 0Population: Data was not collected or analyzed.
To assess for host genetic differences at Day 0 amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 14 daysPopulation: Data was not collected or analyzed.
To assess for host transcriptomic differences at Day 0,7,14 amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups.
Outcome measures
Outcome data not reported
Adverse Events
Convalescent Plasma (Anti-SARS-CoV-2 Plasma)
Serious events: 39 serious events
Other events: 4 other events
Deaths: 19 deaths
Non-convalescent Plasma (Control Plasma)
Serious events: 26 serious events
Other events: 3 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Convalescent Plasma (Anti-SARS-CoV-2 Plasma)
n=147 participants at risk
Convalescent plasma (1 unit; \~200-250 mL) collected from a volunteer who recovered from COVID-19 disease
Convalescent Plasma (anti-SARS-CoV-2 plasma): Convalescent Plasma that contains antibody titers against SARS-CoV-2
|
Non-convalescent Plasma (Control Plasma)
n=72 participants at risk
Non-convalescent plasma (1 unit; \~200-250 mL) of standard plasma collected prior to December 2019
Non-convalescent Plasma (control plasma): Non-convalescent plasma (does not contain antibody titers against SARS-CoV-2)
|
|---|---|---|
|
Vascular disorders
Cardiovascular event
|
10.9%
16/147 • Up to 28 days
Adverse events and serious adverse events were monitored/assessed for a different population of participants (147 out of 150 Convalescent Plasma, and 72 out of 73 Non-convalescent Plasma). Adverse Events and serious adverse events were monitored/assessed without regard to the specific Adverse Event Term, given the circumstances surrounding the pandemic.
|
16.7%
12/72 • Up to 28 days
Adverse events and serious adverse events were monitored/assessed for a different population of participants (147 out of 150 Convalescent Plasma, and 72 out of 73 Non-convalescent Plasma). Adverse Events and serious adverse events were monitored/assessed without regard to the specific Adverse Event Term, given the circumstances surrounding the pandemic.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary adverse event
|
16.3%
24/147 • Up to 28 days
Adverse events and serious adverse events were monitored/assessed for a different population of participants (147 out of 150 Convalescent Plasma, and 72 out of 73 Non-convalescent Plasma). Adverse Events and serious adverse events were monitored/assessed without regard to the specific Adverse Event Term, given the circumstances surrounding the pandemic.
|
22.2%
16/72 • Up to 28 days
Adverse events and serious adverse events were monitored/assessed for a different population of participants (147 out of 150 Convalescent Plasma, and 72 out of 73 Non-convalescent Plasma). Adverse Events and serious adverse events were monitored/assessed without regard to the specific Adverse Event Term, given the circumstances surrounding the pandemic.
|
|
Renal and urinary disorders
Renal/metabolic adverse event
|
4.8%
7/147 • Up to 28 days
Adverse events and serious adverse events were monitored/assessed for a different population of participants (147 out of 150 Convalescent Plasma, and 72 out of 73 Non-convalescent Plasma). Adverse Events and serious adverse events were monitored/assessed without regard to the specific Adverse Event Term, given the circumstances surrounding the pandemic.
|
6.9%
5/72 • Up to 28 days
Adverse events and serious adverse events were monitored/assessed for a different population of participants (147 out of 150 Convalescent Plasma, and 72 out of 73 Non-convalescent Plasma). Adverse Events and serious adverse events were monitored/assessed without regard to the specific Adverse Event Term, given the circumstances surrounding the pandemic.
|
|
Infections and infestations
Infectious adverse event
|
3.4%
5/147 • Up to 28 days
Adverse events and serious adverse events were monitored/assessed for a different population of participants (147 out of 150 Convalescent Plasma, and 72 out of 73 Non-convalescent Plasma). Adverse Events and serious adverse events were monitored/assessed without regard to the specific Adverse Event Term, given the circumstances surrounding the pandemic.
|
13.9%
10/72 • Up to 28 days
Adverse events and serious adverse events were monitored/assessed for a different population of participants (147 out of 150 Convalescent Plasma, and 72 out of 73 Non-convalescent Plasma). Adverse Events and serious adverse events were monitored/assessed without regard to the specific Adverse Event Term, given the circumstances surrounding the pandemic.
|
|
Blood and lymphatic system disorders
Hematologic adverse event
|
4.1%
6/147 • Up to 28 days
Adverse events and serious adverse events were monitored/assessed for a different population of participants (147 out of 150 Convalescent Plasma, and 72 out of 73 Non-convalescent Plasma). Adverse Events and serious adverse events were monitored/assessed without regard to the specific Adverse Event Term, given the circumstances surrounding the pandemic.
|
0.00%
0/72 • Up to 28 days
Adverse events and serious adverse events were monitored/assessed for a different population of participants (147 out of 150 Convalescent Plasma, and 72 out of 73 Non-convalescent Plasma). Adverse Events and serious adverse events were monitored/assessed without regard to the specific Adverse Event Term, given the circumstances surrounding the pandemic.
|
|
Immune system disorders
Inflammatory adverse event
|
0.68%
1/147 • Up to 28 days
Adverse events and serious adverse events were monitored/assessed for a different population of participants (147 out of 150 Convalescent Plasma, and 72 out of 73 Non-convalescent Plasma). Adverse Events and serious adverse events were monitored/assessed without regard to the specific Adverse Event Term, given the circumstances surrounding the pandemic.
|
0.00%
0/72 • Up to 28 days
Adverse events and serious adverse events were monitored/assessed for a different population of participants (147 out of 150 Convalescent Plasma, and 72 out of 73 Non-convalescent Plasma). Adverse Events and serious adverse events were monitored/assessed without regard to the specific Adverse Event Term, given the circumstances surrounding the pandemic.
|
|
Gastrointestinal disorders
Gastrointestinal/hepatic adverse event
|
0.00%
0/147 • Up to 28 days
Adverse events and serious adverse events were monitored/assessed for a different population of participants (147 out of 150 Convalescent Plasma, and 72 out of 73 Non-convalescent Plasma). Adverse Events and serious adverse events were monitored/assessed without regard to the specific Adverse Event Term, given the circumstances surrounding the pandemic.
|
1.4%
1/72 • Up to 28 days
Adverse events and serious adverse events were monitored/assessed for a different population of participants (147 out of 150 Convalescent Plasma, and 72 out of 73 Non-convalescent Plasma). Adverse Events and serious adverse events were monitored/assessed without regard to the specific Adverse Event Term, given the circumstances surrounding the pandemic.
|
Other adverse events
| Measure |
Convalescent Plasma (Anti-SARS-CoV-2 Plasma)
n=147 participants at risk
Convalescent plasma (1 unit; \~200-250 mL) collected from a volunteer who recovered from COVID-19 disease
Convalescent Plasma (anti-SARS-CoV-2 plasma): Convalescent Plasma that contains antibody titers against SARS-CoV-2
|
Non-convalescent Plasma (Control Plasma)
n=72 participants at risk
Non-convalescent plasma (1 unit; \~200-250 mL) of standard plasma collected prior to December 2019
Non-convalescent Plasma (control plasma): Non-convalescent plasma (does not contain antibody titers against SARS-CoV-2)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia, worsening
|
0.68%
1/147 • Up to 28 days
Adverse events and serious adverse events were monitored/assessed for a different population of participants (147 out of 150 Convalescent Plasma, and 72 out of 73 Non-convalescent Plasma). Adverse Events and serious adverse events were monitored/assessed without regard to the specific Adverse Event Term, given the circumstances surrounding the pandemic.
|
1.4%
1/72 • Up to 28 days
Adverse events and serious adverse events were monitored/assessed for a different population of participants (147 out of 150 Convalescent Plasma, and 72 out of 73 Non-convalescent Plasma). Adverse Events and serious adverse events were monitored/assessed without regard to the specific Adverse Event Term, given the circumstances surrounding the pandemic.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.68%
1/147 • Up to 28 days
Adverse events and serious adverse events were monitored/assessed for a different population of participants (147 out of 150 Convalescent Plasma, and 72 out of 73 Non-convalescent Plasma). Adverse Events and serious adverse events were monitored/assessed without regard to the specific Adverse Event Term, given the circumstances surrounding the pandemic.
|
1.4%
1/72 • Up to 28 days
Adverse events and serious adverse events were monitored/assessed for a different population of participants (147 out of 150 Convalescent Plasma, and 72 out of 73 Non-convalescent Plasma). Adverse Events and serious adverse events were monitored/assessed without regard to the specific Adverse Event Term, given the circumstances surrounding the pandemic.
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
0.68%
1/147 • Up to 28 days
Adverse events and serious adverse events were monitored/assessed for a different population of participants (147 out of 150 Convalescent Plasma, and 72 out of 73 Non-convalescent Plasma). Adverse Events and serious adverse events were monitored/assessed without regard to the specific Adverse Event Term, given the circumstances surrounding the pandemic.
|
0.00%
0/72 • Up to 28 days
Adverse events and serious adverse events were monitored/assessed for a different population of participants (147 out of 150 Convalescent Plasma, and 72 out of 73 Non-convalescent Plasma). Adverse Events and serious adverse events were monitored/assessed without regard to the specific Adverse Event Term, given the circumstances surrounding the pandemic.
|
|
Vascular disorders
Transfusion-related circulatory overload
|
1.4%
2/147 • Up to 28 days
Adverse events and serious adverse events were monitored/assessed for a different population of participants (147 out of 150 Convalescent Plasma, and 72 out of 73 Non-convalescent Plasma). Adverse Events and serious adverse events were monitored/assessed without regard to the specific Adverse Event Term, given the circumstances surrounding the pandemic.
|
1.4%
1/72 • Up to 28 days
Adverse events and serious adverse events were monitored/assessed for a different population of participants (147 out of 150 Convalescent Plasma, and 72 out of 73 Non-convalescent Plasma). Adverse Events and serious adverse events were monitored/assessed without regard to the specific Adverse Event Term, given the circumstances surrounding the pandemic.
|
|
General disorders
Possible febrile non-hemolytic transfusion reaction
|
0.00%
0/147 • Up to 28 days
Adverse events and serious adverse events were monitored/assessed for a different population of participants (147 out of 150 Convalescent Plasma, and 72 out of 73 Non-convalescent Plasma). Adverse Events and serious adverse events were monitored/assessed without regard to the specific Adverse Event Term, given the circumstances surrounding the pandemic.
|
1.4%
1/72 • Up to 28 days
Adverse events and serious adverse events were monitored/assessed for a different population of participants (147 out of 150 Convalescent Plasma, and 72 out of 73 Non-convalescent Plasma). Adverse Events and serious adverse events were monitored/assessed without regard to the specific Adverse Event Term, given the circumstances surrounding the pandemic.
|
Additional Information
Max O'Donnell, MD
Columbia University Irving Medical Center
Phone: 212-305-5794
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place