Comparison of Tocilizumab Plus Dexamethasone vs. Dexamethasone for Patients With Covid-19

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Institut National de la Santé Et de la Recherche Médicale, France
• Treatments: Dexamethasone

Criteria

Inclusion Criteria:

1. Patients included in the CORIMUNO-19 cohort

2. Patients belonging to the following group:

• Requiring ≥ 3L/min of oxygen

• WHO progression scale = 5

• No NIV or High flow

Exclusion Criteria:

• Patients with exclusion criteria to the CORIMUNO-19 cohort.

• Known hypersensitivity to Tocilizumab or DXM or to any of their excipients.

• Pregnancy

• Current documented bacterial infection not controlled by antibiotics.

• certain evolving viral diseases (especially active herpes, chickenpox, shingles),

• psychotic states still not controlled by treatment,

• live vaccines in the previous 4 weeks,

• Active tuberculosis or disseminated strongyloidiasis

• 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) < 50 G /L

• SGOT or SGPT > 5N