CORIMUNO-19 - Tocilizumab Trial - TOCI (CORIMUNO-TOCI)
CORIMUNO-19 - Tocilizumab Trial - TOCI (CORIMUNO-TOCI)
The overall objective of the study is to determine the therapeutic effect and tolerance of Tocizilumab 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 COVIMUNO-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 Type: Interventional (Clinical Trial)
Actual Enrollment: 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date: March 30, 2020
Estimated Primary Completion Date: March 31, 2021
Estimated Study Completion Date: December 31, 2021
Arm:
- Experimental: TOCILIZUMAB
- No Intervention: Standard of care
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Expected enrolment | 228 |
| Actual Study start date | 30 March 2020 |
| Estimated Study Completion Date | 31 December 2021 |