Trial Outcomes & Findings for Convalescent Plasma vs. Standard Plasma for COVID-19 (NCT NCT04344535)

NCT ID: NCT04344535

Last Updated: 2021-12-06

Results Overview

Number of days a patient is receiving mechanical invasive ventilation through 28 days post randomization. Patients who die during this time period are assigned 0 ventilator free days.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 82 participants
• Primary outcome timeframe: 28 days post randomization
• Results posted on: 2021-12-06

Participant Flow

8 screen failures prior to randomization, thus 74 patients were randomized.

Participant milestones

Measure	Convalescent Donor Plasma Convalescent Plasma: 450-550 mL of plasma containing anti-SARS-CoV-2 antibody titer ideally \> 1:320, but meeting minimum titer per FDA Guidelines for convalescent plasma.	Standard Donor Plasma Standard Donor Plasma: 450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies
Overall Study STARTED	59	15
Overall Study COMPLETED	59	15
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 Donor Plasma n=59 Participants Convalescent Plasma: 450-550 mL of plasma containing anti-SARS-CoV-2 antibody titer ideally \> 1:320, but meeting minimum titer per FDA Guidelines for convalescent plasma.	Standard Donor Plasma n=15 Participants Standard Donor Plasma: 450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies	Total n=74 Participants Total of all reporting groups
Age, Continuous	67 years STANDARD_DEVIATION 15.8 • n=59 Participants	64 years STANDARD_DEVIATION 17.4 • n=15 Participants	66 years STANDARD_DEVIATION 16.1 • n=74 Participants
Sex: Female, Male Female	23 Participants n=59 Participants	7 Participants n=15 Participants	30 Participants n=74 Participants
Sex: Female, Male Male	36 Participants n=59 Participants	8 Participants n=15 Participants	44 Participants n=74 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Race/Ethnicity, Customized White	42 Participants n=59 Participants	8 Participants n=15 Participants	50 Participants n=74 Participants
Race/Ethnicity, Customized Black	5 Participants n=59 Participants	1 Participants n=15 Participants	6 Participants n=74 Participants
Race/Ethnicity, Customized Other	12 Participants n=59 Participants	6 Participants n=15 Participants	18 Participants n=74 Participants

PRIMARY outcome

Timeframe: 28 days post randomization

Population: All randomized

Number of days a patient is receiving mechanical invasive ventilation through 28 days post randomization. Patients who die during this time period are assigned 0 ventilator free days.

Outcome measures

Measure	Convalescent Donor Plasma n=59 Participants Convalescent Plasma: 450-550 mL of plasma containing anti-SARS-CoV-2 antibody titer ideally \> 1:320, but meeting minimum titer per FDA Guidelines for convalescent plasma.	Standard Donor Plasma n=15 Participants Standard Donor Plasma: 450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies
28 Day Ventilator Free Days	28 days Interval 2.0 to 28.0	28 days Interval 0.0 to 28.0

SECONDARY outcome

Timeframe: 90 days

Population: All randomized

All cause mortality from randomization until 90 days post randomization

Outcome measures

Measure	Convalescent Donor Plasma n=59 Participants Convalescent Plasma: 450-550 mL of plasma containing anti-SARS-CoV-2 antibody titer ideally \> 1:320, but meeting minimum titer per FDA Guidelines for convalescent plasma.	Standard Donor Plasma n=15 Participants Standard Donor Plasma: 450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies
90 Day All-cause Mortality	16 Participants	5 Participants

Adverse Events

Convalescent Donor Plasma

Serious events: 8 serious events

Other events: 0 other events

Deaths: 16 deaths

Standard Donor Plasma

Serious events: 1 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Measure	Convalescent Donor Plasma n=59 participants at risk Convalescent Plasma: 450-550 mL of plasma containing anti-SARS-CoV-2 antibody titer ideally \> 1:320, but meeting minimum titer per FDA Guidelines for convalescent plasma.	Standard Donor Plasma n=15 participants at risk Standard Donor Plasma: 450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies
Renal and urinary disorders Renal Failure	8.5% 5/59 • Adverse Events (death, infusion reaction requiring termination of study plasma infusion, or Grade 4 or greater Organ Failure) were collected for the first 28 days. All-cause mortality was also assessed at 90 days. Adverse Events (death, infusion reaction requiring termination of study plasma infusion, or Grade 4 or greater Organ Failure) were collected for the first 28 days. All-cause mortality was also assessed at 90 days.	0.00% 0/15 • Adverse Events (death, infusion reaction requiring termination of study plasma infusion, or Grade 4 or greater Organ Failure) were collected for the first 28 days. All-cause mortality was also assessed at 90 days. Adverse Events (death, infusion reaction requiring termination of study plasma infusion, or Grade 4 or greater Organ Failure) were collected for the first 28 days. All-cause mortality was also assessed at 90 days.
Respiratory, thoracic and mediastinal disorders Pulmonary Failure	3.4% 2/59 • Adverse Events (death, infusion reaction requiring termination of study plasma infusion, or Grade 4 or greater Organ Failure) were collected for the first 28 days. All-cause mortality was also assessed at 90 days. Adverse Events (death, infusion reaction requiring termination of study plasma infusion, or Grade 4 or greater Organ Failure) were collected for the first 28 days. All-cause mortality was also assessed at 90 days.	0.00% 0/15 • Adverse Events (death, infusion reaction requiring termination of study plasma infusion, or Grade 4 or greater Organ Failure) were collected for the first 28 days. All-cause mortality was also assessed at 90 days. Adverse Events (death, infusion reaction requiring termination of study plasma infusion, or Grade 4 or greater Organ Failure) were collected for the first 28 days. All-cause mortality was also assessed at 90 days.
Hepatobiliary disorders Liver Failure	5.1% 3/59 • Adverse Events (death, infusion reaction requiring termination of study plasma infusion, or Grade 4 or greater Organ Failure) were collected for the first 28 days. All-cause mortality was also assessed at 90 days. Adverse Events (death, infusion reaction requiring termination of study plasma infusion, or Grade 4 or greater Organ Failure) were collected for the first 28 days. All-cause mortality was also assessed at 90 days.	0.00% 0/15 • Adverse Events (death, infusion reaction requiring termination of study plasma infusion, or Grade 4 or greater Organ Failure) were collected for the first 28 days. All-cause mortality was also assessed at 90 days. Adverse Events (death, infusion reaction requiring termination of study plasma infusion, or Grade 4 or greater Organ Failure) were collected for the first 28 days. All-cause mortality was also assessed at 90 days.
Blood and lymphatic system disorders Hematologic Failure	1.7% 1/59 • Adverse Events (death, infusion reaction requiring termination of study plasma infusion, or Grade 4 or greater Organ Failure) were collected for the first 28 days. All-cause mortality was also assessed at 90 days. Adverse Events (death, infusion reaction requiring termination of study plasma infusion, or Grade 4 or greater Organ Failure) were collected for the first 28 days. All-cause mortality was also assessed at 90 days.	6.7% 1/15 • Adverse Events (death, infusion reaction requiring termination of study plasma infusion, or Grade 4 or greater Organ Failure) were collected for the first 28 days. All-cause mortality was also assessed at 90 days. Adverse Events (death, infusion reaction requiring termination of study plasma infusion, or Grade 4 or greater Organ Failure) were collected for the first 28 days. All-cause mortality was also assessed at 90 days.
Blood and lymphatic system disorders Infusion Reaction	1.7% 1/59 • Adverse Events (death, infusion reaction requiring termination of study plasma infusion, or Grade 4 or greater Organ Failure) were collected for the first 28 days. All-cause mortality was also assessed at 90 days. Adverse Events (death, infusion reaction requiring termination of study plasma infusion, or Grade 4 or greater Organ Failure) were collected for the first 28 days. All-cause mortality was also assessed at 90 days.	0.00% 0/15 • Adverse Events (death, infusion reaction requiring termination of study plasma infusion, or Grade 4 or greater Organ Failure) were collected for the first 28 days. All-cause mortality was also assessed at 90 days. Adverse Events (death, infusion reaction requiring termination of study plasma infusion, or Grade 4 or greater Organ Failure) were collected for the first 28 days. All-cause mortality was also assessed at 90 days.

Other adverse events

Adverse event data not reported

Additional Information

Elliott Bennett-Guerrero

Stony Brook University

Phone: 6314446026

Email: elliott.bennett-guerrero@stonybrookmedicine.edu

Results disclosure agreements

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