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

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.

Timeline

Start

2020-04-24

Primary completion

2021-07-06

Completion

2021-08-06

Outcome

Missed primary endpoint

paper Clinical status on the ordinal outcome scale at 14days did not differ between the convalescent plasma and placebo groups in the overall population PMID 35780813 ↗

Publications

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• Self WH, Wheeler AP, Stewart TG, Schrager H, Mallada J, Thomas CB, Cataldo VD, O'Neal HR Jr, Shapiro NI, Higgins C, Ginde AA, Chauhan L, Johnson NJ, Henning DJ, Jaiswal SJ, Mammen MJ, Harris ES, Pannu SR, Laguio-Vila M, El Atrouni W, de Wit M, Hoda D, Cohn CS, McWilliams C, Shanholtz C, Jones AE, Raval JS, Mucha S, Ipe TS, Qiao X, Schrantz SJ, Shenoy A, Fremont RD, Brady EJ, Carnahan RH, Chappell JD, Crowe JE Jr, Denison MR, Gilchuk P, Stevens LJ, Sutton RE, Thomsen I, Yoder SM, Bistran-Hall AJ, Casey JD, Lindsell CJ, Wang L, Pulley JM, Rhoads JP, Bernard GR, Rice TW; Passive Immunity Trial for Our Nation (PassITON) Investigators. Neutralizing COVID-19 Convalescent Plasma in Adults Hospitalized With COVID-19: A Blinded, Randomized, Placebo-Controlled Trial. Chest. 2022 Nov;162(5):982-994. doi: 10.1016/j.chest.2022.06.029. Epub 2022 Jul 1.
• Self WH, Stewart TG, Wheeler AP, El Atrouni W, Bistran-Hall AJ, Casey JD, Cataldo VD, Chappell JD, Cohn CS, Collins JB, Denison MR, de Wit M, Dixon SL, Duggal A, Edwards TL, Fontaine MJ, Ginde AA, Harkins MS, Harrington T, Harris ES, Hoda D, Ipe TS, Jaiswal SJ, Johnson NJ, Jones AE, Laguio-Vila M, Lindsell CJ, Mallada J, Mammen MJ, Metcalf RA, Middleton EA, Mucha S, O'Neal HR Jr, Pannu SR, Pulley JM, Qiao X, Raval JS, Rhoads JP, Schrager H, Shanholtz C, Shapiro NI, Schrantz SJ, Thomsen I, Vermillion KK, Bernard GR, Rice TW; Passive Immunity Trial for Our Nation (PassITON) Investigators. Passive Immunity Trial for Our Nation (PassITON): study protocol for a randomized placebo-control clinical trial evaluating COVID-19 convalescent plasma in hospitalized adults. Trials. 2021 Mar 20;22(1):221. doi: 10.1186/s13063-021-05171-2.
• Self WH, Stewart TG, Wheeler AP, El Atrouni W, Bistran-Hall AJ, Casey JD, Cataldo VD, Chappell JD, Cohn CS, Collins JB, Denison MR, de Wit M, Dixon SL, Duggal A, Edwards TL, Fontaine MJ, Ginde AA, Harkins MS, Harrington T, Harris ES, Hoda D, Ipe TS, Jaiswal SJ, Johnson NJ, Jones AE, Laguio-Vila M, Lindsell CJ, Mallada J, Mammen MJ, Metcalf RA, Middleton EA, Mucha S, O'Neal HR, Pannu SR, Pulley JM, Qiao X, Raval JS, Rhoads JP, Schrager H, Shanholtz C, Shapiro NI, Schrantz SJ, Thomsen I, Vermillion KK, Bernard GR, Rice TW. Passive Immunity Trial for Our Nation (PassITON): study protocol for a randomized placebo-control clinical trial evaluating COVID-19 convalescent plasma in hospitalized adults. Res Sq [Preprint]. 2021 Mar 2:rs.3.rs-227796. doi: 10.21203/rs.3.rs-227796/v1.

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