Status:
COMPLETED
Comparison of Tocilizumab Plus Dexamethasone vs. Dexamethasone for Patients With Covid-19
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Coronavirus Infection
SARS (Severe Acute Respiratory Syndrome)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ass...
Eligibility Criteria
Inclusion
- Patients included in the CORIMUNO-19 cohort
- Patients belonging to the following group:
- Requiring ≥ 3L/min of oxygen
- WHO progression scale = 5
- No NIV or High flow
Exclusion
- 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
Key Trial Info
Start Date :
July 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2021
Estimated Enrollment :
453 Patients enrolled
Trial Details
Trial ID
NCT04476979
Start Date
July 16 2020
End Date
August 11 2021
Last Update
May 31 2024
Active Locations (1)
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1
CH Andrée Rosemon
Cayenne, French Guiana