Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT04355767 · ClinicalTrials.gov registry record · Phase 3

Convalescent Plasma in Outpatients With COVID-19

A Phase 3 study of Covid19, sponsored by Stanford University.

Completed
Registry status
Phase 3
Development phase
511
Enrollment target
20
Study locations

NCT04355767 is a Phase 3 study of Covid19 that has completed, run by Stanford University. The registered enrollment target is 511 participants, below the 2,697-participant average among 94 other Covid19 trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 10 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT04355767, a Phase 3 study of Covid19, 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.

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

FieldValue
Enrollment Target 511 participants
Start Date 2020-08-11
Est. Completion 2021-03-29
Phase Phase 3

Sponsor

Stanford University

1,744 total trials

What the Registry Record Tells You About NCT04355767

The ClinicalTrials.gov registry entry for NCT04355767 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 511 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,697-participant average among 94 other Covid19 trials with a reported enrollment target (81% lower). The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Covid19 appearing as the primary indexed condition, and to 2 interventions - of which Saline is the first listed.

NCT04355767 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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: Covid19.

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.

Similar trials for Covid19

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.