Trial Outcomes & Findings for Efficacy and Safety of Convalescent Plasma in Treating COVID-19 Hospitalized Patients (NCT NCT04354831)

NCT ID: NCT04354831

Last Updated: 2024-04-10

Results Overview

Overall mortality during hospitalization for COVID-19. All patients were followed for the duration of their hospitalization, sometimes exceeding 60 days, through study completion.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 131 participants
• Primary outcome timeframe: Duration of patient hospitalization, sometimes exceeding 60 days
• Results posted on: 2024-04-10

Participant Flow

Participant milestones

Measure	ICU Cohort Patients who are in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma. anti-SARS-CoV-2 convalescent plasma: • SARS-CoV-2 convalescent plasma (1-2 units; \~200-400 mL maximum dose as 7 ml/kg adjusted IBW ) • Study drug will be administered as a single intravenous infusion	Non-ICU Cohort Patients who are NOT in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma. anti-SARS-CoV-2 convalescent plasma: • SARS-CoV-2 convalescent plasma (1-2 units; \~200-400 mL maximum dose as 7 ml/kg adjusted IBW ) • Study drug will be administered as a single intravenous infusion
Overall Study STARTED	41	90
Overall Study COMPLETED	41	89
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	ICU Cohort Patients who are in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma. anti-SARS-CoV-2 convalescent plasma: • SARS-CoV-2 convalescent plasma (1-2 units; \~200-400 mL maximum dose as 7 ml/kg adjusted IBW ) • Study drug will be administered as a single intravenous infusion	Non-ICU Cohort Patients who are NOT in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma. anti-SARS-CoV-2 convalescent plasma: • SARS-CoV-2 convalescent plasma (1-2 units; \~200-400 mL maximum dose as 7 ml/kg adjusted IBW ) • Study drug will be administered as a single intravenous infusion
Overall Study No blood type specific convalescent plasma was available	0	1

Baseline Characteristics

Efficacy and Safety of Convalescent Plasma in Treating COVID-19 Hospitalized Patients

Baseline characteristics by cohort

Measure	ICU Cohort n=41 Participants Patients who are in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma. anti-SARS-CoV-2 convalescent plasma: • SARS-CoV-2 convalescent plasma (1-2 units; \~200-400 mL maximum dose as 7 ml/kg adjusted IBW ) • Study drug will be administered as a single intravenous infusion	Non-ICU Cohort n=90 Participants Patients who are NOT in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma. anti-SARS-CoV-2 convalescent plasma: • SARS-CoV-2 convalescent plasma (1-2 units; \~200-400 mL maximum dose as 7 ml/kg adjusted IBW ) • Study drug will be administered as a single intravenous infusion	Total n=131 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	60 Participants n=7 Participants	89 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	30 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	43 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	47 Participants n=7 Participants	67 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants	85 Participants n=7 Participants	121 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	7 Participants n=7 Participants	8 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	14 Participants n=5 Participants	26 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	54 Participants n=7 Participants	75 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants	90 participants n=7 Participants	131 participants n=5 Participants
BMI	35.34 kg/m^2 n=5 Participants	34.49 kg/m^2 n=7 Participants	34.76 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: Duration of patient hospitalization, sometimes exceeding 60 days

Overall mortality during hospitalization for COVID-19. All patients were followed for the duration of their hospitalization, sometimes exceeding 60 days, through study completion.

Outcome measures

Measure	ICU Cohort n=41 Participants Patients who are in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma. anti-SARS-CoV-2 convalescent plasma: • SARS-CoV-2 convalescent plasma (1-2 units; \~200-400 mL maximum dose as 7 ml/kg adjusted IBW ) • Study drug will be administered as a single intravenous infusion	Non-ICU Cohort n=89 Participants Patients who are NOT in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma. anti-SARS-CoV-2 convalescent plasma: • SARS-CoV-2 convalescent plasma (1-2 units; \~200-400 mL maximum dose as 7 ml/kg adjusted IBW ) • Study drug will be administered as a single intravenous infusion
Overall Mortality	22 Participants	7 Participants

SECONDARY outcome

Timeframe: Length of admission for COVID through study follow-up period

Length of admission after convalescent plasma infusion for all patients. All enrolled patients, whether they were in the ICU cohort or in the non-ICU cohort, were monitored from the time of consent until the time of hospital discharge. Hospital discharge includes those patients who left the hospital alive and those patients who died during their stay.

Outcome measures

Measure	ICU Cohort n=41 Participants Patients who are in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma. anti-SARS-CoV-2 convalescent plasma: • SARS-CoV-2 convalescent plasma (1-2 units; \~200-400 mL maximum dose as 7 ml/kg adjusted IBW ) • Study drug will be administered as a single intravenous infusion	Non-ICU Cohort n=89 Participants Patients who are NOT in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma. anti-SARS-CoV-2 convalescent plasma: • SARS-CoV-2 convalescent plasma (1-2 units; \~200-400 mL maximum dose as 7 ml/kg adjusted IBW ) • Study drug will be administered as a single intravenous infusion
Length of Admission After Plasma Infusion	13.24 days Interval 1.0 to 66.0	7.85 days Interval 1.0 to 76.0

SECONDARY outcome

Timeframe: Length of admission in the ICU for COVID through study follow-up period

Population: Only patients in the ICU Cohort were assessed for this outcome measure

Length of ICU stay after plasma infusion for patients who were in the experimental ICU cohort

Outcome measures

Measure	ICU Cohort n=41 Participants Patients who are in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma. anti-SARS-CoV-2 convalescent plasma: • SARS-CoV-2 convalescent plasma (1-2 units; \~200-400 mL maximum dose as 7 ml/kg adjusted IBW ) • Study drug will be administered as a single intravenous infusion	Non-ICU Cohort Patients who are NOT in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma. anti-SARS-CoV-2 convalescent plasma: • SARS-CoV-2 convalescent plasma (1-2 units; \~200-400 mL maximum dose as 7 ml/kg adjusted IBW ) • Study drug will be administered as a single intravenous infusion
Length of ICU Stay After Convalescent Plasma Infusion	11.98 days Interval 1.0 to 66.0	—

Adverse Events

ICU Cohort

Serious events: 12 serious events

Other events: 0 other events

Deaths: 21 deaths

Non-ICU Cohort

Serious events: 14 serious events

Other events: 4 other events

Deaths: 7 deaths

Serious adverse events

Measure	ICU Cohort n=41 participants at risk Patients who are in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma. anti-SARS-CoV-2 convalescent plasma: • SARS-CoV-2 convalescent plasma (1-2 units; \~200-400 mL maximum dose as 7 ml/kg adjusted IBW ) • Study drug will be administered as a single intravenous infusion	Non-ICU Cohort n=89 participants at risk Patients who are NOT in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma. anti-SARS-CoV-2 convalescent plasma: • SARS-CoV-2 convalescent plasma (1-2 units; \~200-400 mL maximum dose as 7 ml/kg adjusted IBW ) • Study drug will be administered as a single intravenous infusion
Respiratory, thoracic and mediastinal disorders Intubation	26.8% 11/41 • Patients were monitored for adverse events from the time of plasma infusion through the duration of their hospitalization, sometimes exceeding 60 days, through study completion.	7.9% 7/89 • Patients were monitored for adverse events from the time of plasma infusion through the duration of their hospitalization, sometimes exceeding 60 days, through study completion.
Renal and urinary disorders Dialysis	0.00% 0/41 • Patients were monitored for adverse events from the time of plasma infusion through the duration of their hospitalization, sometimes exceeding 60 days, through study completion.	1.1% 1/89 • Patients were monitored for adverse events from the time of plasma infusion through the duration of their hospitalization, sometimes exceeding 60 days, through study completion.
Infections and infestations Bacteremia	9.8% 4/41 • Patients were monitored for adverse events from the time of plasma infusion through the duration of their hospitalization, sometimes exceeding 60 days, through study completion.	1.1% 1/89 • Patients were monitored for adverse events from the time of plasma infusion through the duration of their hospitalization, sometimes exceeding 60 days, through study completion.
Respiratory, thoracic and mediastinal disorders ICU Transfer	0.00% 0/41 • Patients were monitored for adverse events from the time of plasma infusion through the duration of their hospitalization, sometimes exceeding 60 days, through study completion.	15.7% 14/89 • Patients were monitored for adverse events from the time of plasma infusion through the duration of their hospitalization, sometimes exceeding 60 days, through study completion.

Other adverse events

Measure	ICU Cohort n=41 participants at risk Patients who are in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma. anti-SARS-CoV-2 convalescent plasma: • SARS-CoV-2 convalescent plasma (1-2 units; \~200-400 mL maximum dose as 7 ml/kg adjusted IBW ) • Study drug will be administered as a single intravenous infusion	Non-ICU Cohort n=89 participants at risk Patients who are NOT in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma. anti-SARS-CoV-2 convalescent plasma: • SARS-CoV-2 convalescent plasma (1-2 units; \~200-400 mL maximum dose as 7 ml/kg adjusted IBW ) • Study drug will be administered as a single intravenous infusion
General disorders Fever	0.00% 0/41 • Patients were monitored for adverse events from the time of plasma infusion through the duration of their hospitalization, sometimes exceeding 60 days, through study completion.	2.2% 2/89 • Number of events 2 • Patients were monitored for adverse events from the time of plasma infusion through the duration of their hospitalization, sometimes exceeding 60 days, through study completion.
Skin and subcutaneous tissue disorders Rash	0.00% 0/41 • Patients were monitored for adverse events from the time of plasma infusion through the duration of their hospitalization, sometimes exceeding 60 days, through study completion.	2.2% 2/89 • Number of events 2 • Patients were monitored for adverse events from the time of plasma infusion through the duration of their hospitalization, sometimes exceeding 60 days, through study completion.

Additional Information

Mary Beth Graham, MD

Medical College of Wisconsin

Phone: 414-955-0500

Email: mbgraham@mcw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place