A multicenter randomized trial to assess the efficacy of CONvalescent plasma therapy in patients with Invasive COVID-19
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STUDY PROTOCOL
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 Benoît Misset1* , Eric Hoste2, Anne‑Françoise Donneau3, David Grimaldi4, Geert Meyfroidt5, Michel Moutschen6, Veerle Compernolle7, André Gothot8, Daniel Desmecht9, Mutien Garigliany9, Tome Najdovski10 and Pierre‑François Laterre11
Abstract Background: The COVID-19 pandemic reached Europe in early 2020. Convalescent plasma is used without a consist‑ ent evidence of efficacy. Our hypothesis is that passive immunization with plasma collected from patients having contracted COVID-19 and developed specific neutralizing antibodies may alleviate symptoms and reduce mortal‑ ity in patients treated with mechanical ventilation for severe respiratory failure during the evolution of SARS-CoV-2 pneumonia. Methods: We plan to include 500 adult patients, hospitalized in 16 Belgian intensive care units between September 2020 and 2022, diagnosed with SARS-CoV-2 pneumonia, under mechanical ventilation for less than 5 days and a clinical frailty scale less than 6. The study treatment will be compared to standard of care and allocated by randomiza‑ tion in a 1 to 1 ratio without blinding. The main endpoint will be mortality at day 28. We will perform an intention to treat analysis. The number of patients to include is based on an expected mortality rate at day 28 of 40 percent and an expected relative reduction with study intervention of 30 percent with α risk of 5 percent and β risk of 20 percent. Discussion: This study will assess the efficacy of plasma in the population of mechanically ventilated patients. A stratification on the delay from mechanical ventilation and inclusion will allow to approach the optimal time use. Selecting convalescent plasmas with a high titer of neutralizing antibodies against SARS-CoV-2 will allow a homoge‑ neous study treatment. The inclusion in the study is based on the consent of the patient or his/her legal representa‑ tive, and the approval of the Investigational Review Board of the University hospital of Liège, Belgium. A data safety monitoring board (DSMB) has been implemented. Interim analyses have been planned at 100, 2002, 300 and 400 inclusions in order to decide whether the trail should be discontinued prematurely for ethical issues. We plan to pub‑ lish our results in a peer-reviewed journal and to present them at national and international conferences. Funding and registration: The trial is funded by the Belgian Health Care Knowledge Center KCE # COV201004
*Correspondence: [email protected] 1 Department of Intensive Care Medicine, Liege University Hospital, Domaine Universitaire du Sart Tilman, 4020 Liège, Belgium Full list of author information is available at the end of the article © The Author(s) 2020. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adap
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