NCT04344535

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Stony Brook University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID

Interventions

Type	Name	Description
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.
BIOLOGICAL	Standard Donor Plasma	450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies

Timeline

• Start date: 2020-04-08
• Primary completion: 2021-01-01
• Completion: 2021-02-01
• First posted: 2020-04-14
• Last updated: 2021-12-06
• Results posted: 2021-12-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study