Convalescent Plasma in Outpatients With COVID-19

Not Recruiting

Trial ID: NCT04355767


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.

Official Title

Clinical-trial of COVID-19 Convalescent Plasma in Outpatients

Stanford Investigator(s)

Kevin Schulman

Professor of Medicine (Hospital Medicine), by courtesy, of Health Policy and of Operations, Information and Technology at the Graduate School of Business

James Quinn
James Quinn

Professor of Emergency Medicine, Emeritus


Inclusion Criteria:

   - One or more symptoms of COVID-19 illness and laboratory-confirmed SARS-CoV-2 infection

   - Has at least one study defined risk factor for severe COVID-19 illness

   - Clinical team deems stable for outpatient management without supplemental oxygen

   - CP available at the site at the time of enrollment

   - Duration of symptoms ≤ 7 days at ED presentation

   - Informed consent from subject

Exclusion Criteria:

   - Age less than 18 years

   - Prisoner or ward of the state

   - Presumed unable to complete follow-up assessments

   - Prior adverse reaction(s) from blood product transfusion

   - Receipt of any blood product within the past 120 days

   - Treating clinical team unwilling to administer 300 ml fluid

   - Enrollment in another interventional trial for COVID-19 illness


biological: Convalescent Plasma

biological: Saline

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305