TranSfUsion of coNvalescent plAsma for the Early Treatment of pneuMonIa in COVID-19 Patients

Completed 474 enrolled Italian National Institute of Health Agenzia Italiana del Farmaco · collab Gruppo Italiano Malattie EMatologiche dell'Adulto · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a multicenter open-label randomized study for the early treatment of pneumonia due to SARS-COV2 with transfusion of convalescent plasma. Patients with pneumonia due to SARS-CoV-2 will be randomized to receive or not convalescent plasma collected by recovered patients with previous diagnosis of COVID19

Timeline

Start: 2020-07-16
Primary completion: 2021-01-14
Completion: 2021-05-31

Outcome

Missed primary endpoint

paper (odds ratio, 0.88; 95% CI, 0.59-1.33; P = .54). PMID 34842924 ↗

paper high-titer anti-SARS-CoV-2 CP did not reduce the progression to severe respiratory failure or death within 30 days. PMID 34842924 ↗

Publications

Menichetti F, Popoli P, Puopolo M, Spila Alegiani S, Tiseo G, Bartoloni A, De Socio GV, Luchi S, Blanc P, Puoti M, Toschi E, Massari M, Palmisano L, Marano G, Chiamenti M, Martinelli L, Franchi S, Pallotto C, Suardi LR, Luciani Pasqua B, Merli M, Fabiani P, Bertolucci L, Borchi B, Modica S, Moneta S, Marchetti G, d'Arminio Monforte A, Stoppini L, Ferracchiato N, Piconi S, Fabbri C, Beccastrini E, Saccardi R, Giacometti A, Esperti S, Pierotti P, Bernini L, Bianco C, Benedetti S, Lanzi A, Bonfanti P, Massari M, Sani S, Saracino A, Castagna A, Trabace L, Lanza M, Focosi D, Mazzoni A, Pistello M, Falcone M; TSUNAMI Study group. Effect of High-Titer Convalescent Plasma on Progression to Severe Respiratory Failure or Death in Hospitalized Patients With COVID-19 Pneumonia: A Randomized Clinical Trial. JAMA Netw Open. 2021 Nov 1;4(11):e2136246. doi: 10.1001/jamanetworkopen.2021.36246.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Convalescent Plasma	Protein / enzyme biologic	200 ml	Intravenous