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COVID-19 convalescent plasma to treat hospitalised COVID-19 patients with or without underlying immunodeficiency

Lacombe et al., medRxiv, doi:10.1101/2022.08.09.22278329, CORIPLASM, NCT04345991
Aug 2022  
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Mortality 49% Improvement Relative Risk Mortality, immunocom.. 64% Progression, day 4 -68% primary Progression, day 14 -4% primary Hospitalization time -7% Conv. Plasma  CORIPLASM  LATE TREATMENT  RCT Is late treatment with convalescent plasma beneficial for COVID-19? RCT 120 patients in France (April 2020 - April 2021) Lower mortality (p=0.16) and higher progression (p=0.18), not sig. c19early.org Lacombe et al., medRxiv, August 2022 Favorsconv. plasma Favorscontrol 0 0.5 1 1.5 2+
RCT 120 hospitalized patients in France, showing no significant difference in outcomes with convalescent plasma treatment, with the exception of lower mortality in the subgroup of immunosuppressed patients.
risk of death, 49.0% lower, HR 0.51, p = 0.16, treatment 7 of 60 (11.7%), control 12 of 60 (20.0%), NNT 12, adjusted per study, day 28.
risk of death, 64.0% lower, HR 0.36, p = 0.04, treatment 4 of 22 (18.2%), control 11 of 27 (40.7%), NNT 4.4, adjusted per study, day 28, immunocompromised.
risk of progression, 68.3% higher, RR 1.68, p = 0.18, treatment 13 of 60 (21.7%), control 8 of 60 (13.3%), adjusted per study, odds ratio converted to relative risk, WHO-CPS ≥6, day 4, primary outcome.
risk of progression, 4.0% higher, HR 1.04, p = 0.89, treatment 19 of 60 (31.7%), control 20 of 60 (33.3%), NNT 60, adjusted per study, ventilation, additional immunomodulators, or death, day 14, primary outcome.
hospitalization time, 6.7% higher, relative time 1.07, p = 0.99, treatment 60, control 60.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Lacombe et al., 10 Aug 2022, Randomized Controlled Trial, France, preprint, 33 authors, study period 16 April, 2020 - 21 April, 2021, average treatment delay 7.0 days, trial NCT04345991 (history) (CORIPLASM). Contact: karine.lacombe2@aphp.fr, raphael.porcher@aphp.fr.
This PaperConv. PlasmaAll
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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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) &gt;= 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 &gt;= 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. 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Late treatment
is less effective
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