Status:
COMPLETED
Convalescent Plasma in Outpatients With COVID-19
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Strategies to Innovate EmeRgENcy Care Clinical Trials Network
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 illn...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2021
Estimated Enrollment :
511 Patients enrolled
Trial Details
Trial ID
NCT04355767
Start Date
August 11 2020
End Date
March 29 2021
Last Update
October 19 2021
Active Locations (53)
Enter a location and click search to find clinical trials sorted by distance.
1
Chandler Regional Medical Center
Chandler, Arizona, United States, 85224
2
Valleywise Health Medical Center
Phoenix, Arizona, United States, 85008
3
UCSD Health La Jolla
La Jolla, California, United States, 92037
4
Loma Linda University Medical Center
Loma Linda, California, United States, 92354