CORIMUNO-19 - Tocilizumab Trial - TOCI (CORIMUNO-TOCI)

Summary

The overall objective of the study is to determine the therapeutic effect and tolerance of Tocilizumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Tocilizumab (TCZ) is an anti-human IL-6 receptor monoclonal antibody that inhibits signal transduction by binding sIL-6R and mIL-6R. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Tocilizumab administration to patients enrolled in the CORIMUNO-19 cohort. Tocilizumab will be administered to consenting adult patients hospitalized with CORVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Tocilizumab will receive standard of cares. Outcomes of Tocilizumab-treated patients will be compared with outcomes of standard of care treated patients as well as outcomes of patients treated with other immune modulators.

Timeline

Start

2020-03-30

Primary completion

2020-05-04

Completion

2020-11-09

Publications

• Results Hermine O, Mariette X, Tharaux PL, Resche-Rigon M, Porcher R, Ravaud P; CORIMUNO-19 Collaborative Group. Effect of Tocilizumab vs Usual Care in Adults Hospitalized With COVID-19 and Moderate or Severe Pneumonia: A Randomized Clinical Trial. JAMA Intern Med. 2021 Jan 1;181(1):32-40. doi: 10.1001/jamainternmed.2020.6820.
• Results Mariette X, Hermine O, Tharaux PL, Resche-Rigon M, Steg PG, Porcher R, Ravaud P. Effectiveness of Tocilizumab in Patients Hospitalized With COVID-19: A Follow-up of the CORIMUNO-TOCI-1 Randomized Clinical Trial. JAMA Intern Med. 2021 Sep 1;181(9):1241-1243. doi: 10.1001/jamainternmed.2021.2209.
• Results Hermine O, Mariette X, Porcher R, Resche-Rigon M, Tharaux PL, Ravaud P; CORIMUNO-19 Collaborative Group. Effect of interleukin-6 receptor antagonists in critically ill adult patients with COVID-19 pneumonia: two randomised controlled trials of the CORIMUNO-19 Collaborative Group. Eur Respir J. 2022 Aug 10;60(2):2102523. doi: 10.1183/13993003.02523-2021. Print 2022 Aug.
• Lenoir O, Morin F, Walter-Petrich A, Resmini L, Zaidan M, Mahtal N, Ferlicot S, Puelles VG, Wanner N, Dang J, d'Izarny-Gargas T, Biermann J, Izar B, Baron S, Terrier B, Massy ZA, Essig M, Couturier A, May O, Belenfant X, Buob D, Brocheriou I, Izzedine H, Lombardi Y, Francois H, Moktefi A, Audard V, Sannier A, Daugas E, Jamme M, Henry G, Le Monnier de Gouville I, Marie C, Homyrda L, Verstuyft C, Tubiana S, Kafif O, Piquard V, Dougados M, Huber TB, Livrozet M, Hulot JS, Laouenan C, Ghosn J, Mentre F, Karras A, Yazdanpanah Y, Porcher R, Ravaud P, Caillat-Zucman S, Mariette X, Hermine O, Resche-Rigon M, Tharaux PL; CORIMUNO-19 collaborative group. Levels of circulating kidney injury markers and IL-10 identify non-critically ill patients with COVID-19 at risk of death. JCI Insight. 2026 Jan 23;11(2):e198244. doi: 10.1172/jci.insight.198244. eCollection 2026 Jan 23.
• Joly C, Desjardins D, Porcher R, Pere H, Bruneau T, Zhang Q, Bastard P, Cobat A, Resmini L, Lenoir O, Savale L, Lecuroux C, Verstuyft C, Roque-Afonso AM, Veyer D, Baron G, Resche-Rigon M, Ravaud P, Casanova JL, Le Grand R, Hermine O, Tharaux PL, Mariette X. More rapid blood interferon alpha2 decline in fatal versus surviving COVID-19 patients. Front Immunol. 2023 Nov 21;14:1250214. doi: 10.3389/fimmu.2023.1250214. eCollection 2023.
• Tleyjeh IM. The Misleading "Pooled Effect Estimate" of Crude Data from Observational Studies at Critical Risk of Bias: The Case of Tocilizumab in Coronavirus Disease 2019 (COVID-19). Clin Infect Dis. 2021 Jun 15;72(12):e1154-e1155. doi: 10.1093/cid/ciaa1735. No abstract available.

Drugs

Indications