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

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT04331808
Phase
PHASE2
Status
Completed

Conditions

  • Corona Virus Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    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)

Study Details

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.

Key Dates

Start date
Mar 30, 2020
Status verified
Mar 2020
Primary completion
May 4, 2020
Completion
Nov 9, 2020

Study Design

Enrollment
228 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TOCILIZUMAB -- Severe COVID Population (WHO Clinical Progression Scale =5 at baseline)
    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) CPS: Clinical Progression Scale
  • No Intervention: Standard of care -- Severe COVID Population (WHO Clinical Progression Scale =5 at baseline)
    Usual care was provided at the discretion of the clinicians
  • Experimental: TOCILIZUMAB -- Critical COVID Population (WHO Clinical Progression Scale >5 at baseline)
    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) CPS: Clinical Progression Scale
  • No Intervention: Standard of care -- Critical COVID Population (WHO Clinical Progression Scale >5 at baseline)
    Usual care was provided at the discretion of the clinicians

Primary Outcome Measure

Percentage of Participants With WHO Clinical Progression Scale > 5 at Day 4 -- Severe COVID Population (WHO Clinical Progression Scale =5 at Baseline) [ Time Frame: 4 days ]

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