Convalescent Plasma vs. Standard Plasma for COVID-19

Phase 1

Terminated

• Conditions: COVID
• Interventions: Biological: Standard Donor Plasma; Biological: Convalescent Plasma

• Registration Number: NCT04344535
• Lead Sponsor: Stony Brook University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-08
• Study First Submitted: 2020-04-10
• Study First Submitted QC: 2020-04-13
• Study First Posted: 2020-04-14
• Primary Completion: 2021-01-01
• Study Completion: 2021-02-01
• Results First Submitted: 2021-09-20
• Status Verified: 2021-12
• Results First Submitted QC: 2021-12-02
• Last Update Submitted: 2021-12-02
• Results First Posted: 2021-12-06
• Last Update Posted: 2021-12-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Donor Plasma	Standard Donor Plasma	-
Convalescent Donor Plasma	Convalescent Plasma	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
90 Day All-cause Mortality	90 days	All cause mortality from randomization until 90 days post randomization

Trial Locations

Locations (1)

Stony Brook University Hospital; 🇺🇸 Stony Brook, New York, United States