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NCT04355767 · ClinicalTrials.gov registry record · Phase 3
Convalescent Plasma in Outpatients With COVID-19
A Phase 3 study of COVID-19, sponsored by Stanford University.
- Completed
- Registry status
- Phase 3
- Development phase
- 511
- Enrollment target
- 20
- Study locations
NCT04355767: Completed Phase 3 study of COVID-19, sponsored by Stanford University.
NCT04355767 is a Phase 3 study of COVID-19 that has completed, run by Stanford University. The registered enrollment target is 511 participants, below the 38,463-participant average among 298 other COVID-19 trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04355767, a Phase 3 study of COVID-19, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 511 participants
- Enrollment target
- 20
- Study locations
Study 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 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.
Primary Outcome
Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization.
Conditions Studied
Interventions
- BIOLOGICAL Saline
- BIOLOGICAL Convalescent Plasma
Study Locations (20)
California
- UCSD Health La Jolla - La Jolla
- Loma Linda University Medical Center - Loma Linda
- Ronald Reagan UCLA Medical Center - Los Angeles
- Cedars-Sinai Medical Center - Los Angeles
- UC Davis Medical Center - Sacramento
- Stanford University - Stanford
- Harbor-UCLA Medical Center - Torrance
Illinois
- Rush University Medical Center - Chicago
- University of Illinois Hospital - Chicago
- University of Chicago Medical Center - Chicago
Arizona
- Chandler Regional Medical Center - Chandler
- Valleywise Health Medical Center - Phoenix
Florida
- UF Health Shands Hospital - Gainesville
- Jackson Memorial Hospital - Miami
Colorado
- University of Colorado Hospital - Aurora
Georgia
- Grady Memorial Hospital - Atlanta
Iowa
- University of Iowa Hospitals & Clinics - Iowa City
Kentucky
- University of Louisville Hospital - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 511 participants |
| Start Date | 2020-08-11 |
| Est. Completion | 2021-03-29 |
| Phase | Phase 3 |
What the finished NCT04355767 record still lists
NCT04355767 is an interventional study that assigns participants to a tested intervention. The registered 511 participants enrollment target is mid-sized for trials with a published cap, below the 38,463-participant average among 298 other COVID-19 trials with a reported enrollment target (99% lower).
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 2 interventions - of which Saline is the first listed.
NCT04355767 names 20 study sites across 10 states, led by California, Illinois, Arizona.
Frequently Asked Questions
What is clinical trial NCT04355767 about?
NCT04355767 is a clinical study titled "Convalescent Plasma in Outpatients With COVID-19". 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 immunizat...
What is the current status of trial NCT04355767?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 511 participants. The study started on 2020-08-11. Estimated completion is 2021-03-29.
What conditions does trial NCT04355767 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT04355767?
The interventions under investigation include: Saline (BIOLOGICAL), Convalescent Plasma (BIOLOGICAL).
Who is sponsoring clinical trial NCT04355767?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04355767 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04355767's enrollment target sits among peer trials
511 107th of 298 higher than 192 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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