Status:
COMPLETED
Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - Sarilumab Trial - CORIMUNO-19 - SARI
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Corona Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The overall objective of the study is to determine the therapeutic effect and tolerance of Sarilumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disea...
Eligibility Criteria
Inclusion
- Patients included in the CORIMUNO-19 cohort
- Patients belonging to one of the 2 following groups:
- Group 1: patients not requiring Intensive Care Unit at admission with moderate and severe pneumopathy according to the OMS Criteria of severity of COVID pneumopathy.
- Moderate cases :
- Cases meeting all of the following criteria:
- Showing fever and respiratory symptoms with radiological findings of pneumonia.
- Requiring between 3L/min and 5L/min of oxygen to maintain SpO2 \>97% Severe cases
- Cases meeting any of the following criteria:
- Respiratory distress (≧30 breaths/ min);
- Oxygen saturation≤93% at rest in ambient air; or Oxygen saturation ≤97 % with O2 \> 5L/min.
- PaO2/FiO2≦300mmHg
- Group 2: patients requiring Intensive Care Unit based on Criteria of severity of COVID pneumopathy.
- Respiratory failure and requiring mechanical ventilation
- No do-not-resuscitate order (DNR order)
Exclusion
- Patients with exclusion criteria to the CORIMUNO-19 cohort.
- Known hypersensitivity to Sarilumab 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 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2020
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT04324073
Start Date
March 27 2020
End Date
September 24 2020
Last Update
June 12 2025
Active Locations (4)
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1
NECKER Hospital
Paris, France, 75005
2
Kremlin Bicetre hospital APHP
Le Kremlin-Bicêtre, Île-de-France Region, France
3
Cochin Aphp
Paris, Île-de-France Region, France
4
HEGP
Paris, Île-de-France Region, France