Status:
COMPLETED
Passive Immunity Trial for Our Nation to Treat COVID-19 in Hospitalized Adults
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
Dolly Parton
National Center for Advancing Translational Sciences (NCATS)
Conditions:
COVID-19
Coronavirus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 convalesce...
Detailed Description
After being informed about the study and potential risks, participants confirmed to meet all eligibility criteria who have provided informed consent will be randomized 1:1 to convalescent plasma versu...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2021
Estimated Enrollment :
974 Patients enrolled
Trial Details
Trial ID
NCT04362176
Start Date
April 24 2020
End Date
August 6 2021
Last Update
November 3 2022
Active Locations (26)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
Scripps Health
La Jolla, California, United States, 92037
3
University of Colorado Denver
Aurora, Colorado, United States, 80045
4
MedStar Health Research Institute/MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010