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

Recruiting in Palo Alto (17 mi)

+25 other locations

Overseen byTodd Rice, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Vanderbilt University Medical Center

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Todd Rice, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

Inclusion Criteria

Age greater than or equal to 18 years

Currently hospitalized or in an emergency department with anticipated hospitalization

Cough

See 3 more

Treatment Details

Interventions

pathogen reduced SARS-CoV-2 convalescent plasma (Passive Antibody Therapy)
Placebo (Other)

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: pathogen reduced SARS-CoV-2 convalescent plasmaExperimental Treatment1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.