CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 228 enrolled
Drug / intervention
Tocilizumabdrug
Likely dose
Tocilizumab 8mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04331808
NCT04331808Phase 2Completed

Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - Tocilizumab Trial - CORIMUNO-19 - TOCI (CORIMUNO-TOCI)

Assistance Publique - Hôpitaux de Paris·interventional·Posted Apr 2, 2020·Updated Jun 12, 2025

In Brief

A Phase 2 clinical trial evaluating Tocilizumab for Corona Virus Infection. Completed, enrolled 228 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedApr 2, 2020
Enrollment StartMar 30, 2020
Primary CompletionMay 4, 2020
Study CompletionNov 9, 2020
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 6.3 years ago

Interventions

Tocilizumabdrug

Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg)