Status:
SUSPENDED
Study of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients: Sarilumab, Azithromycin, Hydroxychloroquine Trial - CORIMUNO-19 - VIRO
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
COVID19
SARS-CoV-2 Infection
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
The overall objective of the study is to determine the therapeutic effect and tolerance of Sarilumab in combination with Azithromycin and Hydroxychloroquine, compared to Sarilumab only, patients with ...
Eligibility Criteria
Inclusion
- Patients included in the CORIMUNO-19 cohort (NCT04324047)
- COVID-19 cases not requiring ICU at admission with moderate or severe pneumopathy according to the WHO Criteria of severity of COVID pneumopathy:
- Moderate cases: Cases meeting all of the following criteria: \[Showing fever and respiratory symptoms with radiological findings of pneumonia\] AND \[Requiring between 3L/min and 5L/min of oxygen to maintain SpO2\>97%\] OR
- Severe cases: Cases meeting any of the following criteria: \[Respiratory distress ( ≥ 30 breaths/ min)\] OR \[Oxygen saturation≤93% at rest in ambient air; or Oxygen saturation ≤97 % with O2 \> 5L/min\] OR \[PaO2/FiO2 ≤ 300mmHg\]
Exclusion
- Patients with exclusion criteria to the CORIMUNO-19 cohort.
- Respiratory failure requiring non invasive or mechanical ventilation
- Patients requiring intensive care
- Do-not-resuscitate order (DNR order)
- Known hypersensitivity to sarilumab or to any of their excipients.
- Known contra-indication to hydroxychloroquine or chloroquine: including hypersensitivity/allergy, retinopathy, G6PD deficiency and QT prolongation
- Known contra-indication to azithromycin: including hypersensitivity/allergy and QT prolongation
- Pregnancy or breastfeeding
- 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 :
April 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2020
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04341870
Start Date
April 11 2020
End Date
August 1 2020
Last Update
May 6 2020
Active Locations (5)
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1
AP-HP Hôpital Avicenne
Bobigny, France
2
AP-HP Hôpital Ambroise Paré
Boulogne-Billancourt, France
3
AP-HP Hôpital Beaujon
Clichy, France
4
AP-HP Hôpital Pitié Salpétrière
Paris, France