Convalescent Plasma vs. Standard Plasma for COVID-19

COVID Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04344535
• Other study ID #: SBU-COVID19-ConvalescentPlasma
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: April 8, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: December 2021
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 82
• Est. completion date: February 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID
• COVID-19

Intervention

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.
• Standard Donor Plasma
450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies

Locations

Country	Name	City	State
United States	Stony Brook University Hospital	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	90 Day All-cause Mortality	All cause mortality from randomization until 90 days post randomization	90 days