CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 974 enrolled
Drug / intervention
pathogen reduced SARS-CoV-2 convalescent plasma +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04362176
NCT04362176Phase 3Completed
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Passive Immunity Trial for Our Nation (PassItOn)

Vanderbilt University Medical Center·interventional·Posted Apr 24, 2020·Updated Nov 3, 2022

In Brief

A Phase 3 clinical trial evaluating pathogen reduced SARS-CoV-2 convalescent plasma and Placebo for COVID-19 and 2 related conditions. Completed, enrolled 974 participants across 26 sites.

Detailed 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 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19, Coronavirus, SARS-CoV-2
CountriesUnited States
CollaboratorsDolly Parton, National Center for Advancing Translational Sciences (NCATS)

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedApr 24, 2020
Enrollment StartApr 24, 2020
Primary CompletionJul 6, 2021
Study CompletionAug 6, 2021
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 6.2 years ago

Interventions

pathogen reduced SARS-CoV-2 convalescent plasmabiological

Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.

Placebobiological

Lactated Ringer's solution with multivitamins