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

NCT04331808 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2025-06-12

Study results available
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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.

Conditions

  • Corona Virus Infection

Interventions

DRUG

Tocilizumab

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)

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Xavier MARIETTE, MD PhD · Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-30
Primary Completion
2020-05-04
Completion
2020-11-09

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04331808 on ClinicalTrials.gov