Efficacy of CONvalescent Plasma in Patients With COVID-19 Treated With Mechanical Ventilation

Summary

The principal objective of the CONFIDENT trial is to assess the efficacy of two units (400-500 mL in total) of convalescent plasma, as compared to Standard of Care (SoC), to reduce day-28 mortality in patients with SARS-CoV-2 pneumonia who require mechanical ventilation.

Timeline

Start

2020-09-11

Primary completion

2022-04-09

Completion

2023-03-09

Outcome

Met primary endpoint

paper At day 28, mortality was 35.4% in the convalescent-plasma group and 45.0% in the standard-care group (P = 0.03). PMID 37889107 ↗

paper the administration of plasma collected from convalescent donors with a neutralizing antibody titer of at least 1:160 to patients with Covid-19-induced ARDS within 5 days after the initiation of invasive mechanical ventilation significantly reduced mortality at day 28. PMID 37889107 ↗

Publications

• Rousseau AF, Dardenne N, Bertrand A, Piagnerelli M, Hoste E, Grimaldi D, Michaux I, De Waele E, Dumoulin A, Jorens PG, van der Hauwaert E, Vallot F, Lamote S, Swinnen W, De Schryver N, Fraipont V, de Mey N, Dauby N, Layios N, Mesland JB, Donneau AF, Laterre PF, Misset B. Health-related quality of life trajectories one year after COVID-19-induced ARDS: A secondary analysis of the CONFIDENT trial. Ann Intensive Care. 2026 Jan 16;16:100009. doi: 10.1016/j.aicoj.2025.100009. eCollection 2026.
• Misset B, Diep AN, Bertrand A, Piagnerelli M, Hoste E, Michaux I, De Waele E, Dumoulin A, Jorens PG, van der Hauwaert E, Vallot F, Swinnen W, De Schryver N, de Mey N, Layios N, Mesland JB, Robinet S, Cavalier E, Donneau AF, Moutschen M, Laterre PF. Immunological sub-phenotypes and response to convalescent plasma in COVID-19 induced ARDS: a secondary analysis of the CONFIDENT trial. Ann Intensive Care. 2024 Oct 21;14(1):160. doi: 10.1186/s13613-024-01392-1.
• Misset B, Piagnerelli M, Hoste E, Dardenne N, Grimaldi D, Michaux I, De Waele E, Dumoulin A, Jorens PG, van der Hauwaert E, Vallot F, Lamote S, Swinnen W, De Schryver N, Fraipont V, de Mey N, Dauby N, Layios N, Mesland JB, Meyfroidt G, Moutschen M, Compernolle V, Gothot A, Desmecht D, Taveira da Silva Pereira MI, Garigliany M, Najdovski T, Bertrand A, Donneau AF, Laterre PF. Convalescent Plasma for Covid-19-Induced ARDS in Mechanically Ventilated Patients. N Engl J Med. 2023 Oct 26;389(17):1590-1600. doi: 10.1056/NEJMoa2209502. Epub 2023 Oct 25.
• Misset B, Hoste E, Donneau AF, Grimaldi D, Meyfroidt G, Moutschen M, Compernolle V, Gothot A, Desmecht D, Garigliany M, Najdovski T, Laterre PF. A multicenter randomized trial to assess the efficacy of CONvalescent plasma therapy in patients with Invasive COVID-19 and acute respiratory failure treated with mechanical ventilation: the CONFIDENT trial protocol. BMC Pulm Med. 2020 Dec 7;20(1):317. doi: 10.1186/s12890-020-01361-x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Convalescent Plasma	Protein / enzyme biologic	400 ml	—

Indications