Passive Immunity Trial Of the Nation for COVID-19
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 Ordinal Outcomes Scale at Day 15, among adults with COVID-19 requiring hospitalization.
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Age ≥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, fever (> 37.5° C / 99.5° F), shortness of breath
- Laboratory-confirmed SARS-CoV-2 infection within the past 10 days
- Unable to randomize within 14 days after onset of acute respiratory infection symptoms
- Unable to randomize within 48 hours after hospital arrival
- Inability to be contacted on Day 29-36 for clinical outcome assessment
- Receipt of pooled immunoglobulin in the past 30 days
- Contraindications to transfusion or history of prior reactions to transfusion blood products
- Previous enrollment in this trial
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Eligible participants will be randomized 1:1 to convalescent plasma versus lactated Ringer's solution with multivitamins. Randomization will be completed in permuted blocks and stratified by site, gender, and age. Participants, treating clinicians and outcomes assessors will all be blinded to study group assignment. Study personnel will not be blinded to the study group assignment.
- Primary Purpose
- Triple (Participant, Care Provider, Outcomes Assessor)
pathogen reduced SARS-CoV-2 convalescent plasma
|Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.||
|Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.||
- Vanderbilt University Medical Center
Study ContactAmanda J Bistran-Hall
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 versus placebo. Transfusion of convalescent plasma or placebo will be administered by clinical or research personnel while the patient is hospitalized on Study Day 0. On Study Days 1-7, participants will be monitored for adverse reactions to the transfusion. Research personnel will also assess patients at Day 14 and Day 28; these assessments will be completed by phone if the participant has been discharged from the hospital.