Convalescent Plasma in Outpatients With COVID-19

Trial ID or NCT#



not recruiting iconNOT RECRUITING


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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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


Michelle Y. Williams PhD, RN, FAAN
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
Emergency medicine doctor, Pediatric emergency medicine doctor
Professor of Emergency Medicine, Emeritus