Convalescent Plasma vs. Standard Plasma for COVID-19

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

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.

Study Overview

• Status: Terminated
• Conditions: COVID
• Intervention / Treatment: Biological: Convalescent Plasma; Biological: Standard Donor Plasma

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.
• Bennett-Guerrero E, Romeiser JL, Talbot LR, Ahmed T, Mamone LJ, Singh SM, Hearing JC, Salman H, Holiprosad DD, Freedenberg AT, Carter JA, Browne NJ, Cosgrove ME, Shevik ME, Generale LM, Andrew MA, Nachman S, Fries BC; Stony Brook Medicine COVID Plasma Trial Group. Severe Acute Respiratory Syndrome Coronavirus 2 Convalescent Plasma Versus Standard Plasma in Coronavirus Disease 2019 Infected Hospitalized Patients in New York: A Double-Blind Randomized Trial. Crit Care Med. 2021 Jul 1;49(7):1015-1025. doi: 10.1097/CCM.0000000000005066.

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2020
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: April 10, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): December 6, 2021
• Last Update Submitted That Met QC Criteria: December 2, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: SBU-COVID19-ConvalescentPlasma

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No