Phase 2
N=228
CORIMUNO-19 - Tocilizumab Trial - TOCI (CORIMUNO-TOCI)
Corona Virus Infection
Bottom Line
View on ClinicalTrials.gov: NCT04331808 ↗Enrolled (actual)
228
Serious AEs
48.2%
Results posted
Jun 2025
Primary outcome: Primary: Percentage of Participants With WHO Clinical Progression Scale > 5 at Day 4 -- Severe COVID Population (WHO Clinical Progression Scale =5 at Baseline) — 19; 28 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tocilizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With WHO Clinical Progression Scale > 5 at Day 4 -- Severe COVID Population (WHO Clinical Progression Scale =5 at Baseline) |
19; 28 | — |
| PRIMARY Percentage of Participants With Non-invasive Ventilation, Mechanical Ventilation or Death at Day 14 (WHO Clinical Progression Scale =5 at Baseline) |
24; 36 | — |
| PRIMARY Percentage of Participants With no Improvement in WHO Clinical Progression Scale at Day 4 -- Critical COVID Population ( WHO Clinical Progression Scale >5 at Baseline) |
71; 70 | — |
| PRIMARY Cumulative Incidence (Percentage of Participants) With Successful Tracheal Extubation at Day 14 -- Critical COVID Population (WHO Clinical Progression Scale >5 at Baseline) |
47; 42 | — |
| SECONDARY Percentage of Participants Surviving (Overall Survival) |
89; 91; 90; 79; 89; 88 | — |
| SECONDARY WHO Progression Scale |
5; 5; 7; 8; 5; 5 | — |
| SECONDARY Mean of Ventilator Free-days at Day 28 -- Critical COVID Population (WHO-clinical Progression Scale >5 at Baseline) |
12.8; 10.3 | — |
| SECONDARY Cumulative Incidence (Percentage of Participants) of Oxygen Supply Independency |
89; 75; 59; 49; 69; 64 | — |
| SECONDARY Cumulative Incidence (Percentage of Participants) of Discharge From Hospital |
83; 73; 55; 42; 70; 60 | — |
| SECONDARY Cumulative Incidence (Percentage of Participants) of Intensive Care Unit Discharge -- Critical COVID Population (WHO Clinical Progression Scale >5 at Baseline) |
72; 60; 84; 83 | — |
| SECONDARY PaO2/FIO2 Ratio -- Critical COVID Population (WHO Clinical Progression Scale >5 at Baseline) |
155.1; 135.0; 144.0; 143.8; 126.0; 142.8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients included in the CORIMUNO-19 cohort
- Patients belonging to one of the 2 following groups:
- Group 1: Cases meeting all of the following criteria
- Requiring more than 3L/min of oxygen
- OMS/WHO progression scale = 5
- No Non Invasive Ventilation or High flow
- Group 2: Cases meeting all of the following criteria
- Respiratory failure AND (requiring mechanical ventilation OR Non Invasive Ventilation OR High flow)
- WHO progression scale >=6
- No do-not-resuscitate order (DNR order)
Exclusion Criteria
- Patients with exclusion criteria to the CORIMUNO-19 cohort.
- Known hypersensitivity to Tocilizumab or to any of their excipients.
- Pregnancy
- Current documented bacterial infection
- Patient with any of following laboratory results out of the ranges detailed below at screening should be discussed depending of the medication:
- Absolute neutrophil count (ANC) ≤ 1.0 x 109/L
- Haemoglobin level: no limitation
- Platelets (PLT) 5N
Data sourced from ClinicalTrials.gov (NCT04331808). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.