Comparison of Tocilizumab Plus Dexamethasone vs. Dexamethasone for Patients With Covid-19
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
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
Phase:
Phase 2
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France