Trials / Completed
CompletedNCT04476979
Comparison of Tocilizumab Plus Dexamethasone vs. Dexamethasone for Patients With Covid-19
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 453 (actual)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The overall objective of the study is to determine the therapeutic effect and tolerance of Tocilizumab combined with Dexamethasone 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 Dexamethasone alone or Dexamethasone +Tocilizumab administration to patients enrolled in the CORIMUNO-19 cohort. Tocilizumab will be administered to consenting adult patients hospitalized with COVID-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 (including Dexamethasone) treated patients
Conditions
- Coronavirus Infection
- SARS (Severe Acute Respiratory Syndrome)
- Virus Diseases
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Respiratory Tract Infections
- Respiratory Tract Disease
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tocilizumab | Tocilizumab 8mg/kg D1 and if no response (No decrease of oxygen requirement) a second fixed dose of 400mg wil be administered at D3 |
| DRUG | Dexamethasone | Dexamethasone : 10 mg once daily for the first five days (day 1 to day 5) then 5 mg per day for up to 5 days, 2.5mg per day for up to 4 days (or until oxygen supply independency if sooner) |
Timeline
- Start date
- 2020-07-16
- Primary completion
- 2021-06-01
- Completion
- 2021-08-11
- First posted
- 2020-07-20
- Last updated
- 2024-05-31
Locations
1 site across 1 country: French Guiana
Source: ClinicalTrials.gov record NCT04476979. Inclusion in this directory is not an endorsement.