Status:
COMPLETED
CORIMUNO-ANA: Trial Evaluating Efficacy Of Anakinra In Patients With Covid-19 Infection
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 Anakinra in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus diseas...
Eligibility Criteria
Inclusion
- Patients included in the CORIMUNO-19 cohort
- Patients with C-reactive protein level (CRP) \> 25 mg / L the day or the day before the infusion)
- Patients belonging to one of the 2 following groups:
- Group 1: patients meeting all of the following criteria: 1) Requiring more than 3L/min of oxygen; 2) WHO progression scale = 5; 3) No non invasive ventilation or High flow
- Group 2: patients with respiratory failure AND (requiring mechanical ventilation OR non invasive ventilation OR High flow), with a WHO progression scale ≥ 6, and no do-not-resuscitate (DNR) order
Exclusion
- Patients with exclusion criteria to the CORIMUNO-19 cohort.
- Known hypersensitivity to Anakinra 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:
- Absolute neutrophil count (ANC) ≤ 1.0 x 109/L
- Haemoglobin level: no limitation
- Platelets (PLT) \< 50 G /L
- SGOT or SGPT \> 5N
- Severe renal insufficiency with Glomerular filtration rate \< 30 ml / mn
Key Trial Info
Start Date :
April 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2020
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT04341584
Start Date
April 8 2020
End Date
July 25 2020
Last Update
June 6 2025
Active Locations (1)
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1
Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris
Le Kremlin-Bicêtre, France