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Convalescent Plasma in Outpatients With COVID-19
Not Recruiting
Trial ID: NCT04355767
Purpose
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
Professor of Emergency Medicine, Emeritus
Eligibility
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
Intervention(s):
biological: Convalescent Plasma
biological: Saline
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305