Status:
COMPLETED
CORIMUNO-19 - Tocilizumab Trial - TOCI (CORIMUNO-TOCI)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Corona Virus Infection
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 in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus dis...
Eligibility Criteria
Inclusion
- Patients included in the CORIMUNO-19 cohort
- Patients belonging to one of the 2 following groups:
- Group 1: Cases meeting all of the following criteria
- Requiring more than 3L/min of oxygen
- OMS/WHO progression scale = 5
- No Non Invasive Ventilation or High flow
- Group 2: Cases meeting all of the following criteria
- Respiratory failure AND (requiring mechanical ventilation OR Non Invasive Ventilation OR High flow)
- WHO progression scale \>=6
- No do-not-resuscitate order (DNR order)
Exclusion
- Patients with exclusion criteria to the CORIMUNO-19 cohort.
- Known hypersensitivity to Tocilizumab or to any of their excipients.
- Pregnancy
- Current documented bacterial infection
- 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 :
March 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2020
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT04331808
Start Date
March 30 2020
End Date
November 9 2020
Last Update
June 12 2025
Active Locations (8)
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1
APHP- Hopital Tenon
Paris, France, 75012
2
APHP - Beaujon
Paris, France
3
APHP - Bichat
Paris, France
4
APHP - Hopital Necker
Paris, France