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. 2023 Oct 27;2(1):e000427.
doi: 10.1136/bmjmed-2022-000427. eCollection 2023.

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

Karine Lacombe  1   2   3 , Thomas Hueso  4   5 , Raphael Porcher  6   7 , Arsene Mekinian  1   8 , Thibault Chiarabini  3 , Sophie Georgin-Lavialle  1   9 , Florence Ader  10   11 , Julien Saison  12 , Guillaume Martin-Blondel  13   14 , Nathalie De Castro  15 , Fabrice Bonnet  16   17 , Charles Cazanave  18   19 , Anne Francois  20 , Pascal Morel  20 , Olivier Hermine  21   22 , Valerie Pourcher  1   2   23 , Marc Michel  24   25 , Xavier Lescure  21   26 , Nora Soussi  27 , Phillipe Brun  28 , Fanny Pommeret  29 , Pierre Sellier  30 , Stella Rousset  14 , Lionel Piroth  31 , Jean-Marie Michot  29 , Gabriel Baron  6   7 , Xavier de Lamballerie  32 , Xavier Mariette  33   34 , Pierre-Louis Tharaux  35 , Matthieu Resche-Rigon  36   37 , Philippe Ravaud  36   37 , Tabassome Simon  1   38 , Pierre Tiberghien  20   39
Affiliations

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

Karine Lacombe et al. BMJ Med. .

Abstract

Objective: To 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).

Design: Open label, randomised clinical trial.

Setting: CORIMUNO-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.

Participants: 120 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 <9 days, and World Health Organization score of 4 or 5. 49 patients (n=22, n=27) had underlying immunosuppression.

Interventions: Open label randomisation to usual care or four units (200-220 mL/unit, 2 units/day over two consecutive days) of covid-19 convalescent plasma with a seroneutralisation titre >40.

Main outcome measures: Primary 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.

Results: 120 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 the usual care group by day 28 (adjusted hazard ratio 0.51, 0.20 to 1.32). In a subgroup analysis performed in patients who were immunocompromised, transfusion of covid-19 convalescent plasma was associated with mortality (hazard ratio 0.39, 95% confidence interval 0.14 to 1.10).

Conclusions: In this study, covid-19 convalescent plasma did not improve early outcomes in patients with moderate covid-19 disease. The efficacy of convalescent plasma in patients who are immunocompromised should be investigated further.

Trial registration: ClinicalTrials.gov NCT04345991.

Keywords: COVID-19; blood transfusion; clinical trial.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: support from Programme Hospitalier de recherche Clinique (DGOS-French Ministry of Health), Fondation pour la Recherche Médicale, Sorbonne Université AAP 2020, and Emergency Support Instrument (ESI), Direction Générale de la Santé, European Commission for the submitted work; PT, PM, and AF are employees of Etablissement Français du Sang (EFS), the French public transfusion service, which collects, manufactures, tests and issues all blood components in France; KL is contributing to the development of monoclonal and polyclonal anti-SARS-CoV Antibodies (Spikimm, Xenothera, Fabentech); no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

Figures

Figure 1
Figure 1
Flowchart of CORIPLASM (Efficacy of Convalescent Plasma to Treat COVID-19 Patients, a Nested Trial in the CORIMUNO-19 Cohort) clinical trial. *No SARS-CoV-2 infection. †Received non-invasive ventilation. ICU=intensive care unit
Figure 2
Figure 2
Study outcomes in covid-19 convalescent plasma and usual care groups. Cumulative incidence of non-invasive or mechanical ventilation, use of additional immunomodulatory drugs, or death over 14 days (events on day 1 of randomisation occurred on the same day but after randomisation). CrI=credible interval
Figure 3
Figure 3
Overall survival during follow-up in covid-19 convalescent plasma and usual care groups. CI=confidence interval
Figure 4
Figure 4
Distribution of World Health Organization Clinical Progression Scale scores during follow-up in covid-19 convalescent plasma and usual care groups
Figure 5
Figure 5
Subgroup analyses. Day 14 primary outcomes (need for non-invasive or mechanical ventilation, use of additional immunomodulatory drugs, or death) in covid-19 convalescent plasma and usual care groups. Dashed line indicates overall estimate of treatment effect. Because only one patient was receiving antiviral agents at randomisation, no subgroup analysis according to antiviral agents was done. CI=confidence interval
Figure 6
Figure 6
Overall survival during follow-up in patients with immunosuppression in covid-19 convalescent plasma and usual care groups. CI=confidence interval
Figure 7
Figure 7
Overall survival during follow-up in patients with no underlying immunodeficiency in covid-19 convalescent plasma and usual care groups. CI=confidence interval
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