Convalescent Plasma in Outpatients With COVID-19

Summary

The overarching goal of this project is to confirm or refute the role of passive immunization as a safe and efficacious therapy in preventing the progression from mild to severe/critical COVID-19 illness and to understand the immunologic kinetics of anti-SARS-CoV-2 antibodies after passive immunization.The primary objective is to determine the efficacy and safety of a single dose of convalescent plasma (CP) for preventing the progression from mild to severe COVID-19 illness. The secondary objective is to characterize the immunologic response to CP administration.

This study will enroll adults presenting to the emergency department (ED) with mild, symptomatic, laboratory-confirmed COVID-19 illness, who are at high risk for progression to severe/critical illness, but who are clinically stable for outpatient management at randomization.

Conditions

• Covid19

Interventions

BIOLOGICAL

Convalescent Plasma

SARS-CoV-2 convalescent plasma with neutralizing SARS-CoV2 antibodies titers of ≥1:160 administered via intravenous (IV) infusion.

BIOLOGICAL

Saline

Saline with multivitamin administered via intravenous (IV) infusion..

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Strategies to Innovate EmeRgENcy Care Clinical Trials Network

  collaborator NETWORK

• University of Pittsburgh

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• Stanford University

  lead OTHER

Principal Investigators

• Clifton W Callaway, MD, PhD · University of Pittsburgh

• Valerie Durkalski-Mauldin, PhD · Medical University of South Carolina

• Frederick Korley, MD, PhD · University of Michigan

• Sharon Yeatts, PhD · Medical University of South Carolina

• Robert Silbergleit, MD · University of Michigan

• William Barsan, MD · University of Michigan

• Kevin Schulman, MD · Stanford University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-11

Primary Completion

2021-03-29

Completion

2021-03-29

FDA Drug

Yes

Countries

• United States

Study Locations