Convalescent Plasma in Outpatients With COVID-19
Completed · Phase 3 · Has a placebo group
Conditions studied: Covid19
In brief
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.
Key facts
- Study ID
- NCT04355767
- Run by
- Stanford University
- People needed
- 511
- Starts
- 2020-08-11
- Expected to finish
- 2021-03-29
- Last updated by the study team
- 2021-10-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify 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
Where it is running
- Valleywise Health Medical Center — Phoenix, Arizona, United States
- UCSD Health La Jolla — La Jolla, California, United States
- Loma Linda University Medical Center — Loma Linda, California, United States
- Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- UC Davis Medical Center — Sacramento, California, United States
- Stanford University — Stanford, California, United States
- Harbor-UCLA Medical Center — Torrance, California, United States
- University of Colorado Hospital — Aurora, Colorado, United States
- UF Health Shands Hospital — Gainesville, Florida, United States
- Jackson Memorial Hospital — Miami, Florida, United States
- Grady Memorial Hospital — Atlanta, Georgia, United States
- Rush University Medical Center — Chicago, Illinois, United States
- University of Illinois Hospital — Chicago, Illinois, United States
- University of Chicago Medical Center — Chicago, Illinois, United States
- University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
- University of Louisville Hospital — Louisville, Kentucky, United States
- Maine Medical Center — Portland, Maine, United States
- Tufts Medical Center — Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Newton-Wellesley Hospital — Newton, Massachusetts, United States
- Baystate Medical Center — Springfield, Massachusetts, United States
- University of Michigan University Hospital — Ann Arbor, Michigan, United States
- Detroit Receiving Hospital — Detroit, Michigan, United States
- Chandler Regional Medical Center — Chandler, Arizona, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.