Convalescent Plasma in Outpatients With COVID-19
Trial ID or NCT#
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.
Clinical-trial of COVID-19 Convalescent Plasma in Outpatients
- - 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
- - 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