COVID-19 convalescent plasma to treat hospitalised COVID-19 patients with or without underlying immunodeficiency
Karine Lacombe, Thomas Hueso, Raphael Porcher, Arsène Mekinian, Thibault Chiarabini, Sophie Georgin-Lavialle, Florence Ader, Julien Saison, Guillaume Martin Blondel, Nathalie De Castro, Fabrice Bonnet, Charles Cazanave, Anne François, Pascal Morel, Olivier Hermine, Valérie Pourcher, Marc Michel, Xavier Lescure, Nora Soussi, Philippe Brun, Fanny Pommeret, Pierre-Olivier Sellier, Stella Rousset, Lionel Piroth, Jean-Marie Michot, Gabriel Baron, Xavier De Lamballerie, Xavier Mariette, Pierre-Louis Tharaux, Matthieu Resche-Rigon, Philippe Ravaud, Tabassome Simon, Pierre Tiberghien
doi:10.1101/2022.08.09.22278329
The authors wish to thank all physicians, nurses, and assistant nurses who took care of the patients, clinical research assistants and clinical research doctors who included and followed the patients during the trial, physicians, nurses and staff involved in convalescent plasma collection, manufacturing, testing and issuing, and above all the patients who agreed to participate in the study and the convalescent donors who generously gave their plasma. Special thanks to the DRCI of Assistance Publique-Hôpitaux de Paris (APHP), the trial sponsor, and the Unité de Recherche de l'Est Parisien (URC-EST, APHP.SU, site St Antoine site), which managed the trial.
Role of the funding source The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. Contributors KL and PT were involved in the protocol design and study design, including conceptualization, methodology, funding acquisition, and resources. NS and TS did the data curation, investigation,
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DOI record:
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"abstract": "<jats:p>Background: Efficacy of COVID-19 convalescent plasma (CCP) in COVID-19 pneumonia is uncertain. Early transfusion of high antibody titre CCP may be beneficial, especially in case of underlying immunosuppression. Methods: The CORIPLASM study was a multicentric, open-label, Bayesian randomised clinical trial evaluating the efficacy of CCP in patients with moderate COVID-19 pneumonia, including patients with underlying immunosuppression. Patients hospitalised with COVID-19 for less than 9 days were assigned to receive 2 plasma units/day over 2 days (CCP) or usual care (UC) alone. Primary outcomes were the proportion of patients with a WHO-Clinical Progression Score (CPS) >= 6 on the 10-point scale on day 4 and survival without ventilation or additional immunomodulatory treatment by day 14. Main analysis was conducted on the whole population and a planned subgroup analysis was performed according to immunosuppression status. Findings: A total of 120 patients were recruited between April 16, 2020, and April 21, 2021, and assigned to CCP (n=60) or UC (n=60) with a 28 day-follow-up. The median time from symptoms onset to randomisation (days) was 7.0 [interquartile range (IQR) 5.0-9.0] and 7.0 [IQR 4.0-8.5] in CCP and UC, respectively. Thirteen (22%) patients with CCP had a WHO-CPS >= 6 at day 4 versus 8 (13%) with UC, adjusted odds ratio (aOR) 1.88 [95% confidence interval (CI), 0.71 to 5.24]. By d14, 19 (31.6%) patients with CCP and 20 (33.3%) patients with UC had ventilation, additional immunomodulatory treatment or had died. Cumulative incidence of death was 3 (5%) with CCP and 8 (13%) with UC at d14 (aHR 0.40 [95%CI 0.10 -1.53]), and 7 (12%) with CCP and 12 (20%) with UC at day 28 (aHR 0.51 [95% CI 0.20-1.32]). Subgroup analysis indicated that CCP might be associated with a lower mortality in patients with underlying immunosuppression (HR 0.37 [95% CI 0.14-0.97]). Serious adverse events were noted in 30 (50%) and 26 (43%) patients with CCP or UC, respectively. Interpretation: CCP treatment did not improve early outcomes in patients with mild-to-moderate form COVID-19 pneumonia but was associated with reduced mortality in the subgroup of immunosuppressed patients. Trial registration: clinicaltrials.gov Identifier:<jats:ext-link xmlns:xlink=\"http://www.w3.org/1999/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04345991\">NCT04345991</jats:ext-link></jats:p>",
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