PARIS, April 27 (WNM/AP-HP) - Researchers at the Assistance Publique-Hôpitaux de Paris (AP-HP) published preliminary results from a study of tocilizumab, a monoclonal antibody utilized for the treatment of rheumatoid arthritis (https://www.aphp.fr/contenu/tocilizumab-improves-significantly-clinical-outcomes-patients-moderate-or-severe-covid-19).
In a randomized clinical trial, 65 COVID-19 patients were treated using standard care and tocilizumab, and 64 patients were treated using standard care only.
The drug was evaluated as a potential treatment to mitigate the “cytokine storm” that is believed to contribute to acute respiratory failure and death in COVID-19 patients.
According to a press release published by AP-HP, the patients that received the drug were significantly less likely to die or require mechanical ventilation over a 14-day period.
The study has not yet undergone peer review, and no further information regarding the study methodology or data is presented. The press release emphasizes that additional study is required to confirm the results:
"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."