First results of the CORIMUNO-TOCI open-label randomized controlled trial.
In patients with COVID-19 pneumonia, an immune-mediated “cytokine storm” is believed to lead to acute respiratory failure and death. The CORIMUNO-19 platform was swiftly designed and set up to evaluate the efficacy and tolerance of various immune modulators and other treatments in adult patients with severe COVID-19 infection with series of multicenter randomized controlled trials that started March 27, 2020. This report pertains to a multicenter open-label randomized controlled trial of tocilizumab, a monoclonal antibody blocking the receptor for the interleukin-6 cytokine, used clinically in particular in the treatment of rheumatoid arthritis.
Patients were selected on the basis of being hospitalized for COVID-19 moderate or severe pneumonia not requiring intensive care upon admission. The primary composite outcome was need for ventilation (non-invasive or mechanical) or death at day 14.
A total of 129 patients were randomized: 65 to standard of care + tocilizumab and 64 to standard of care alone. A significantly lower proportion of patients reached the primary outcome in the tocilizumab arm. Results of this study will be submitted for publication in a peer-reviewed journal.
These results should be confirmed independently by additional trials. Given the pandemic context, the investigators and sponsor felt ethically obligated to disclose this information, pending peer review and while continuing to accrue longer follow-up. Additional CORIMUNO trials testing other IL-6 receptor inhibitors and other immunomodulators are currently being analyzed.
This multicenter trial was conducted through the Assistance Publique - Hôpitaux de Paris/Universities/INSERM-REACTing COVID-19 academic research collaboration
- Coordinating investigator : Pr O. Hermine, Hôpital Necker, AP-HP, Imagine Institute, INSERM U1163, Université de Paris
- Co-coordinating investigator : Pr X. Mariette, Hôpital Bicêtre, AP-HP, INSERM U1184, Université Paris-Saclay
- Scientific director : Dr P.L. Tharaux, PARCC, INSERM U970, Hôpital Européen Georges Pompidou, AP-HP, Université de Paris
- Design and coordination of the CORIMUNO trial platform: Pr P. Ravaud, Center for Clinical Epidemiology, Hôpital Hôtel Dieu, AP-HP, CRESS, INSERM U1153, Université de Paris
- Statistician : Dr R. Porcher, Center for Clinical Epidemiology, Hôpital Hôtel Dieu, AP-HP, CRESS, INSERM U1153 Université de Paris
- Monitoring and data management : Pr M. Resche-Rigon (Clinical Trial Unit, Hôpital Saint Louis, AP-HP), CRESS, INSERM U1153, Université de Paris.
- Organisation of data collection : Pr M. Dougados, Hôpital Cochin, AP-HP, CRESS, INSERM U1153, Université de Paris
The CORIMUNO-19 trials platform is sponsored and funded by Assistance Publique-Hôpitaux de Paris, and supported by Reacting/INSERM.
The trial received grant support from the Programme Hospitalier de Recherche Clinique of the French Ministry of Health, initiation funding from the REACTing/INSERM Network via the Fondation pour la Recherche Médicale, Paris, France, and a grant from the Fondation AP-HP pour la recherche, Paris, France. Tocilizumab as well as 4000 Elecsys IL-6 dosages were provided for free in an unrestricted manner by Roche, which was involved in neither trial design, data collection, analysis, interpretation, manuscript writing nor in the governance.
REACTing is a collaborative network of major French institutions, coordinated by Inserm for Avisean, to optimise research capacity during epidemics & improve research preparedness in between epidemics through multidisciplinary collaboration.
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