Convalescent Plasma vs. Standard Plasma for COVID-19

• Sponsor: Stony Brook University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04344535
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.8
• Patients Per Site Per Month: 8.3

Study Details

Study Description

Brief Summary

The purpose of this study is to find out if transfusion of blood plasma containing antibodies against COVID-19 (anti-SARS-CoV-2), which were donated from a patient who recovered from COVID-19 infection, is safe and can treat COVID-19 in hospitalized patients.

Antibodies are blood proteins produced by the body in response to a virus and can remain in the person's bloodstream (plasma) for a long time after they recover. Transferring plasma from a person who recovered from COVID-19 may help neutralize the virus in sick patients' blood, and/or reduce the chances of the infection getting worse.

Condition or Disease	Intervention/Treatment	Phase
COVID	Biological: Convalescent Plasma; Biological: Standard Donor Plasma	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Staff in Transfusion Services (Blood Bank) at Stony Brook will be unblinded so they can collect, store, and dispense either convalescent plasma or standard plasma. They will affix an approved label with all required information, e.g. bar code, blood type, expiration date, and will indicate that the bag contains convalescent plasma/standard plasma.
• Primary Purpose: Treatment
• Official Title: Convalescent Plasma to Reduce Complications Associated With COVID-19 Infection: A Randomized Trial Comparing the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma vs. Standard Plasma in Hospitalized Patients With COVID- 19 Infection
• Actual Study Start Date: Apr 8, 2020
• Actual Primary Completion Date: Jan 1, 2021
• Actual Study Completion Date: Feb 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Convalescent Donor Plasma	Biological: 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.
Placebo Comparator: Standard Donor Plasma	Biological: Standard Donor Plasma; 450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies

Outcome Measures

Primary Outcome Measures

1. 28 Day Ventilator Free Days [28 days post randomization]

   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.

Secondary Outcome Measures

1. 90 Day All-cause Mortality [90 days]

   All cause mortality from randomization until 90 days post randomization

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

There are 2 groups of research subjects: plasma donor and recipients

Volunteer plasma donors can donate Convalescent Plasma if they:

• have adequate antibody levels against COVID-19 per FDA Guidelines

• have had no symptoms of COVID-19 for at least 14 days

• meet routine plasma donation criteria

Inclusion Criteria for Plasma Recipients:

• Adults 18 years of age or older

• Hospitalized with PCR+ COVID-19 infection

• If female must not be pregnant and/or breastfeeding.

Exclusion Criteria for Plasma Recipients:

• Unable to randomize patient within 14 days of admission to Stony Brook Hospital (or any other hospital if a transfer to Stony Brook Hospital).

• In the treating physician's opinion, the patient cannot tolerate a 450-550 mL infusion of plasma over up to 8 hours (4 hours max per unit), even if prophylaxed with intravenous diuretic

• Contraindication to transfusion or history of prior reactions to blood transfusions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stony Brook University Hospital	Stony Brook	New York	United States	11794

Sponsors and Collaborators

• Stony Brook University

Investigators

• Principal Investigator: Elliott Bennett-Guerrero, MD, Stony Brook Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 16, 2020

More Information

Publications

None provided.

• Responsible Party: Elliott Bennett-Guerrero, Professor of Anesthesiology, Stony Brook University
• ClinicalTrials.gov Identifier: NCT04344535
• Other Study ID Numbers: SBU-COVID19-ConvalescentPlasma
• First Posted: Apr 14, 2020
• Last Update Posted: Dec 6, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19

Study Results

Participant Flow

Pre-assignment Detail	8 screen failures prior to randomization, thus 74 patients were randomized.

Arm/Group Title	Convalescent Donor Plasma	Standard Donor Plasma
Arm/Group Description	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: 450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies
Period Title: Overall Study
STARTED	59	15
COMPLETED	59	15
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Convalescent Donor Plasma	Standard Donor Plasma	Total
Arm/Group Description	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: 450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies	Total of all reporting groups
Overall Participants	59	15	74
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67 (15.8)	64 (17.4)	66 (16.1)
Sex: Female, Male (Count of Participants)
Female	23 39%	7 46.7%	30 40.5%
Male	36 61%	8 53.3%	44 59.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	42 71.2%	8 53.3%	50 67.6%
Black	5 8.5%	1 6.7%	6 8.1%
Other	12 20.3%	6 40%	18 24.3%

Outcome Measures

1. Primary Outcome

Title	28 Day Ventilator Free Days
Description	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.
Time Frame	28 days post randomization

Outcome Measure Data

Analysis Population Description

All randomized

Arm/Group Title	Convalescent Donor Plasma	Standard Donor Plasma
Arm/Group Description	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: 450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies
Measure Participants	59	15
Median (Inter-Quartile Range) [days]	28	28

2. Secondary Outcome

Title	90 Day All-cause Mortality
Description	All cause mortality from randomization until 90 days post randomization
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

All randomized

Arm/Group Title	Convalescent Donor Plasma	Standard Donor Plasma
Arm/Group Description	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: 450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies
Measure Participants	59	15
Count of Participants [Participants]	16 27.1%	5 33.3%

Adverse Events

Time Frame	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 Event Reporting Description	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.
Arm/Group Title	Convalescent Donor Plasma		Standard Donor Plasma
Arm/Group Description	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: 450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies
All Cause Mortality
	Convalescent Donor Plasma		Standard Donor Plasma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/59 (27.1%)		5/15 (33.3%)
Serious Adverse Events
	Convalescent Donor Plasma		Standard Donor Plasma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/59 (13.6%)		1/15 (6.7%)
Blood and lymphatic system disorders
Hematologic Failure	1/59 (1.7%)		1/15 (6.7%)
Infusion Reaction	1/59 (1.7%)		0/15 (0%)
Hepatobiliary disorders
Liver Failure	3/59 (5.1%)		0/15 (0%)
Renal and urinary disorders
Renal Failure	5/59 (8.5%)		0/15 (0%)
Respiratory, thoracic and mediastinal disorders
Pulmonary Failure	2/59 (3.4%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Convalescent Donor Plasma		Standard Donor Plasma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.