Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

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 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

Keywords

Covid19 Convalescent Plasma Saline

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UCSD Medical Center - Hillcrest Hospital
    San Diego California 92103 United States
  • Harbor-UCLA Medical Center
    Torrance California 90502 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Stanford University
Links
SIREN Network Statistical Design and Analysis Plan for Sequential Parallel-Group RCT for COVID-19 (Harrell and Lindsell, 2020)
ID
NCT04355767
Phase
Phase 3
Study Type
Interventional
Last Updated