Use of covid-19 convalescent plasma to treat patients admitted to hospital for covid-19 with or without underlying immunodeficiency: open label, randomised clinical trial

• Published in: BMJ medicine 2023-10, Vol.2 (1), p.e000427
• Main Authors: Lacombe, Karine, Hueso, Thomas, Porcher, Raphael, Mekinian, Arsene, Chiarabini, Thibault, Georgin-Lavialle, Sophie, Ader, Florence, Saison, Julien, Martin-Blondel, Guillaume, De Castro, Nathalie, Bonnet, Fabrice, Cazanave, Charles, Francois, Anne, Morel, Pascal, Hermine, Olivier, Pourcher, Valerie, Michel, Marc, Lescure, Xavier, Soussi, Nora, Brun, Phillipe, Pommeret, Fanny, Sellier, Pierre, Rousset, Stella, Piroth, Lionel, Michot, Jean-Marie, Baron, Gabriel, de Lamballerie, Xavier, Mariette, Xavier, Tharaux, Pierre-Louis, Resche-Rigon, Matthieu, Ravaud, Philippe, Simon, Tabassome, Tiberghien, Pierre
• Format: Article
• Language: English
• Subjects: blood transfusion; clinical trial; COVID-19; Life Sciences; Original Research; Santé publique et épidémiologie
• ISSN: 2754-0413; 2754-0413
• DOI: 10.1136/bmjmed-2022-000427

ObjectiveTo evaluate the efficacy of covid-19 convalescent plasma to treat patients admitted to hospital for moderate covid-19 disease with or without underlying immunodeficiency (CORIPLASM trial).DesignOpen label, randomised clinical trial.SettingCORIMUNO-19 cohort (publicly supported platform of open label, randomised controlled trials of immune modulatory drugs in patients admitted to hospital with moderate or severe covid-19 disease) based on 19 university and general hospitals across France, from 16 April 2020 to 21 April 2021.Participants120 adults (n=60 in the covid-19 convalescent plasma group, n=60 in the usual care group) admitted to hospital with a positive SARS-CoV2 test result, duration of symptoms 40.Main outcome measuresPrimary outcomes were proportion of patients with a WHO Clinical Progression Scale score of ≥6 on the 10 point scale on day 4 (higher values indicate a worse outcome), and survival without assisted ventilation or additional immunomodulatory treatment by day 14. Secondary outcomes were changes in WHO Clinical Progression Scale scores, overall survival, time to discharge, and time to end of dependence on oxygen supply. Predefined subgroups analyses included immunosuppression status, duration of symptoms before randomisation, and use of steroids.Results120 patients were recruited and assigned to covid-19 convalescent plasma (n=60) or usual care (n=60), including 22 (covid-19 convalescent plasma) and 27 (usual care) patients who were immunocompromised. 13 (22%) patients who received convalescent plasma had a WHO Clinical Progression Scale score of ≥6 at day 4 versus eight (13%) patients who received usual care (adjusted odds ratio 1.88, 95% credible interval 0.71 to 5.24). By day 14, 19 (31.6%) patients in the convalescent plasma group and 20 (33.3%) patients in the usual care group needed ventilation, additional immunomodulatory treatment, or had died. For cumulative incidence of death, three (5%) patients in the convalescent plasma group and eight (13%) in the usual care group died by day 14 (adjusted hazard ratio 0.40, 95% confidence interval 0.10 to 1.53), and seven (12%) patients in the convalescent plasma group and 12 (20%) in