Phase 3 N=239 Randomized Treatment

Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - Sarilumab Trial - CORIMUNO-19 - SARI

Corona Virus Infection

Bottom Line

View on ClinicalTrials.gov: NCT04324073 ↗

Enrolled (actual)

239

Serious AEs

46.7%

Results posted

Jun 2025

Primary outcome: Primary: Percentage of Participants With WHO Clinical Progression Scale > 5 at Day 4 -- Severe COVID Population (WHO Clinical Progression Scale =5 at Baseline) — 26; 26 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Sarilumab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Assistance Publique - Hôpitaux de Paris
Primary completion: Apr 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With WHO Clinical Progression Scale > 5 at Day 4 -- Severe COVID Population (WHO Clinical Progression Scale =5 at Baseline)	26; 26	—
PRIMARY Percentage of Participants With Non-invasive Ventilation, Mechanical Ventilation or Death at Day 14 (WHO Clinical Progression Scale =5 at Baseline)	37; 34	—
PRIMARY Percentage of Participants With no Improvement in WHO Clinical Progression Scale at Day 4 -- Critical COVID Population ( WHO Clinical Progression Scale >5 at Baseline)	71; 79	—
PRIMARY Cumulative Incidence (Percentage of Participants) With Successful Tracheal Extubation at Day 14 -- Critical COVID Population (WHO Clinical Progression Scale >5 at Baseline)	38; 33	—
SECONDARY Percentage of Participants Surviving (Overall Survival)	91; 89; 75; 73; 88; 82	—
SECONDARY WHO Progression Scale	5; 5; 7; 8; 5; 5	—
SECONDARY Mean of Ventilator Free-days at Day 28 -- Critical COVID Population (WHO-clinical Progression Scale >5 at Baseline)	10.3; 8.7	—
SECONDARY Cumulative Incidence (Percentage of Participants) of Oxygen Supply Independency	75; 71; 44; 36; 81; 78	—
SECONDARY Cumulative Incidence (Percentage of Participants) of Discharge From Hospital	75; 70; 35; 30; 79; 76	—
SECONDARY Cumulative Incidence (Percentage of Participants) of Intensive Care Unit Discharge -- Critical COVID Population (WHO Clinical Progression Scale >5 at Baseline)	60; 71; 79; 82	—
SECONDARY PaO2/FiO2 Ratio -- Critical COVID Population (WHO-CPS >5)	177.8; 106.4; 143.0; 156.4; 142.4; 157.0	—

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 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 Sarilumab administration to patients enrolled in the CORIMUNO-19 cohort. Sarilumab will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Sarilumab will receive standard of care. Outcomes of Sarilumab-treated patients will be compared with outcomes of standard of care-treated patients as well as with outcomes of patients treated with other immune modulators.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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) 5N

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04324073). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.