Study of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients: Sarilumab, Azithromycin, Hydroxychloroquine Trial - CORIMUNO-19 - VIRO

NCT ID: NCT04341870

Last Updated: 2020-05-06

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-11
• Study Completion Date: 2020-08-31

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 moderate, severe pneumonia associated with Coronavirus disease 2019 (COVID-19). Sarilumab is a human IgG1 monoclonal antibody that binds specifically to both soluble and membrane-bound IL-6Rs (sIL-6Rα and mIL-6Rα) and has been shown to inhibit IL-6-mediated signaling through these receptors. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering investigational treatments administration to patients enrolled in the CORIMUNO-19 cohort (NCT04324047). Sarilumab+Azithromycin+Hydroxychloroquine, or Sarilumab only will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation. All patients will receive standard of care along with randomized investigational treatments. Outcomes of included patients will be compared between groups as well as with outcomes of patients in the CORIMUNO-19 cohort treated with other immune modulators or standard of care.

Conditions

COVID19; SARS-CoV-2 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sarilumab + Azithromycin + Hydroxychloroquine

Sarilumab combined with Azithromycin and Hydroxychloroquine

Group Type: EXPERIMENTAL

Sarilumab

Intervention Type: DRUG

Sarilumab: 400 mg in a 1 hour - I.V. infusion on D1

Azithromycin

Intervention Type: DRUG

Azithromycin: oral administration, 500mg on D1 then 250mg QD on D2 to D5 (total duration 5 days)

Hydroxychloroquine

Intervention Type: DRUG

Hydroxychloroquine: oral administration, 600mg QD (200mg TID) from D1 to D10 (total duration 10 days)

Sarilumab

Sarilumab only

Group Type: ACTIVE_COMPARATOR

Sarilumab

Intervention Type: DRUG

Sarilumab: 400 mg in a 1 hour - I.V. infusion on D1

Interventions

Sarilumab

Sarilumab: 400 mg in a 1 hour - I.V. infusion on D1

Intervention Type: DRUG

Azithromycin

Azithromycin: oral administration, 500mg on D1 then 250mg QD on D2 to D5 (total duration 5 days)

Intervention Type: DRUG

Hydroxychloroquine

Hydroxychloroquine: oral administration, 600mg QD (200mg TID) from D1 to D10 (total duration 10 days)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

2. Respiratory failure requiring non invasive or mechanical ventilation

3. Patients requiring intensive care

4. Do-not-resuscitate order (DNR order)

5. Known hypersensitivity to sarilumab or to any of their excipients.

6. Known contra-indication to hydroxychloroquine or chloroquine: including hypersensitivity/allergy, retinopathy, G6PD deficiency and QT prolongation

7. Known contra-indication to azithromycin: including hypersensitivity/allergy and QT prolongation

8. Pregnancy or breastfeeding

9. Current documented bacterial infection.

10. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AP-HP Hôpital Avicenne

Bobigny, , France

AP-HP Hôpital Ambroise Paré

Boulogne-Billancourt, , France

AP-HP Hôpital Beaujon

Clichy, , France

AP-HP Hôpital Pitié Salpétrière

Paris, , France

AP-HP Hôpital Saint Antoine

Paris, , France

Countries

France

Other Identifiers

APHP200375-3

Identifier Type: -

Identifier Source: org_study_id