Trial Outcomes & Findings for Use of Convalescent Plasma for COVID-19 (NCT NCT04408040)
NCT ID: NCT04408040
Last Updated: 2022-11-14
Results Overview
Number of patients who survived the covid infection after treatment on study.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
30 days after initial treatment
Results posted on
2022-11-14
Participant Flow
Enrollment period 7/14/2020-9/13/2021 Subjects were recruited from the hospital, outpatient clinic and from marketing efforts
Participant milestones
| Measure |
Critical Patients
Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19
|
Severe Patients
Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19
|
High Risk
Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19
|
Health Care Providers
Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
1
|
6
|
1
|
|
Overall Study
COMPLETED
|
0
|
1
|
6
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Convalescent Plasma for COVID-19
Baseline characteristics by cohort
| Measure |
Critical Patients
Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19
|
Severe Patients
n=1 Participants
Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19
|
High Risk
n=6 Participants
Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19
|
Health Care Providers
n=1 Participants
Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
—
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Continuous
|
—
|
63 years
n=7 Participants
|
37 years
n=5 Participants
|
25 years
n=4 Participants
|
37 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
—
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
—
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
—
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
—
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
1 participants
n=4 Participants
|
8 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 30 days after initial treatmentPopulation: no critical patients were enrolled.
Number of patients who survived the covid infection after treatment on study.
Outcome measures
| Measure |
Critical Patients
Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19
|
Severe Patients
n=1 Participants
Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19
|
High Risk
n=6 Participants
Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19
|
Health Care Providers
n=1 Participants
Convalescent Plasma: 200-425mL convalescent plasma donated by patients previously positive for COVID-19
|
|---|---|---|---|---|
|
Arms 1 & 2: Number of COVID-19 Infected Patients in Severe, High Risk & Health Care Provider Cohorts Who Survive the Infection
|
0 Participants
|
1 Participants
|
6 Participants
|
1 Participants
|
Adverse Events
Critical Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Severe Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Risk
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Care Providers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 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