Passive Immunity Trial for Our Nation to Treat COVID-19 in Hospitalized Adults

Completed · Phase 3 · Has a placebo group

Conditions studied: COVID-19, Coronavirus, SARS-CoV-2

In brief

The purpose of this study is to test the safety and efficacy of convalescent donor plasma to treat COVID-19 in hospitalized adults in a randomized, placebo-controlled setting. The effect of convalescent plasma will be compared to placebo on clinical outcomes, measured using the COVID-19 7-point Ordinal Clinical Progression Outcomes Scale at Day 15, among adults with COVID-19 requiring hospitalization.

Key facts

Study ID

NCT04362176

Run by

Vanderbilt University Medical Center

People needed

974

Starts

2020-04-24

Expected to finish

2021-08-06

Last updated by the study team

2022-11-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age greater than or equal to 18 years
• Currently hospitalized or in an emergency department with anticipated hospitalization
• Symptoms of acute respiratory infection, defined as one or more of the following:
• Cough
• Chills, or a fever (greater than 37.5° C or 99.5° F)
• Shortness of breath, operationalized as a patient having any of the following:
• i. Subjective shortness of breath reported by a patient or surrogate. ii. Tachypnea with respiratory rate of greater than 22 breaths per minute iii. Hypoxemia, defined as SpO2 less than 92% on room air, new receipt of supplemental oxygen to maintain SpO2 greater than or equal to 92%, or increased supplemental oxygen to maintain SpO2 greater than or equal to 92% for a patient on chronic oxygen therapy
• Laboratory-confirmed SARS-CoV-2 infection within the past 14 days

You may not qualify if…

• Prisoner
• Unable to randomize within 14 days after onset of acute respiratory infection symptoms
• Patient, legal representative, or physician not committed to full support (Exception: a patient who will receive all supportive care except for attempts at resuscitation from cardiac arrest will not be excluded.)
• Inability to be contacted on Day 29-36 for clinical outcome assessment
• Receipt of any SARS-CoV-2 passive immunity therapy, such as convalescent plasma, monoclonal antibodies, or pooled immunoglobulin, in the past 30 days
• Contraindications to transfusion or history of prior reactions to transfused blood products
• Plan for hospital discharge within 24 hours of enrollment
• Previous enrollment in this trial
• Previous laboratory-confirmed SARS-CoV-2 infection before the current illness
• Enrollment in another clinical trial evaluating monoclonal antibodies, convalescent plasma, or another passive immunity therapy
• Prior receipt of SARS-CoV-2 vaccine

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Scripps Health — La Jolla, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• MedStar Health Research Institute/MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• The University of Kansas Medical Center — Kansas City, Kansas, United States
• Our Lady of the Lake Regional Medical Center — Baton Rouge, Louisiana, United States
• University of Maryland, Baltimore (University of Maryland Medical Center) — Baltimore, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Newton-Wellelsey Hospital — Newton, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• University of New Mexico Health Sciences Center — Albuquerque, New Mexico, United States
• University at Buffalo/Buffalo General Medical Center — Buffalo, New York, United States
• Rochester General Hospital — Rochester, New York, United States
• Cleveland Clinic Ohio — Cleveland, Ohio, United States
• The Ohio State University Wexner Medical Center and James Cancer Hospital — Columbus, Ohio, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Meharry Medical College — Nashville, Tennessee, United States
• Utah Valley Hospital — Provo, Utah, United States
• University of Utah Health — Salt Lake City, Utah, United States
• Sentara Norfolk General Hospital — Norfolk, Virginia, United States
• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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