Primary Objective: To evaluate the clinical efficacy of sarilumab relative to the control arm in adult participants hospitalized with severe or critical Coronavirus Disease 2019 (COVID-19). Secondary Objectives: - Evaluate the 28-day survival rate. - Evaluate the clinical efficacy of sarilumab compared to the control arm by clinical severity. - Evaluate changes in the National Early Warning Score 2. - Evaluate the duration of predefined symptoms and signs (if applicable). - Evaluate the duration of supplemental oxygen dependency (if applicable). - Evaluate the incidence of new mechanical ventilation use during the study. - Evaluate the duration of new mechanical ventilation use during the Study. - Evaluate the proportion of participants requiring rescue medication during the 28-day period. - Evaluate need for admission into intensive care unit. - Evaluate duration of hospitalization (days). - The secondary safety objectives of the study were to evaluate the safety of sarilumab through hospitalization (up to Day 29 if participant was still hospitalized) compared to the control arm as assessed by incidence of: - Serious adverse events. - Major or opportunistic bacterial or fungal infections in participants with grade 4 neutropenia. - Grade greater than or equal to (>=) 2 infusion related reactions. - Grade >=2 hypersensitivity reactions. - Increase in alanine transaminase (ALT) >=3X upper limit of normal (ULN) (for participants with normal baseline) or greater than 3X ULN AND at least 2-fold increase from baseline value (for participants with abnormal baseline). - Major or opportunistic bacterial or fungal infections.
An individual participant would complete the study approximately 60 days from screening to
follow-up on day 60 ±7 days.
Drug: Sarilumab SAR153191
Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion
Other Name: Array
Drug: Placebo
Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion
Inclusion criteria :
Participants must be >=18 years of age. Participants must be hospitalized for less than or
equal to 7 days with evidence of pneumonia and have one of the following disease
categories: severe disease or critical disease.
Laboratory-confirmed severe acute respiratory syndrome coronavirus 2 infection.
Exclusion criteria:
Unlikely to survive after 48 hours from screening or unlikely to remain at the
investigational site beyond 48 hours. Participants with multi organ dysfunction or
requiring extracorporeal life support or renal replacement therapy were excluded.
Presence of neutropenia less than 2000/cubic millimeter (mmˆ3), aspartate transaminase or
ALT greater than 5X ULN, platelets less than 50,000/mmˆ3.
Prior immunosuppressive therapies. Use of systemic chronic corticosteroids for non-COVID-19
related condition. Known or suspected history of tuberculosis. Suspected or known active
systemic bacterial or fungal infections.
The above information was not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.
Investigational Site Number 0320001
Caba, Argentina
Investigational Site Number 0320003
Caba, Argentina
Investigational Site Number 0320004
Caba, Argentina
Investigational Site Number 0760003
Porto Alegre, Brazil
Investigational Site Number 0760001
Sao Paulo, Brazil
Investigational Site Number 0760002
Sao Paulo, Brazil
Investigational Site Number 0760004
São José Do Rio Preto, Brazil
Investigational Site Number 0760005
São Paulo, Brazil
Investigational Site Number 1240001
Montreal, Canada
Investigational Site Number 1240005
Montreal, Canada
Investigational Site Number 1240004
Toronto, Canada
Investigational Site Number 1240002
Toronto, Canada
Investigational Site Number 1240003
Vancouver, Canada
Investigational Site Number 1520003
Santiago, Chile
Investigational Site Number 1520002
Santiago, Chile
Investigational Site Number 1520004
Santiago, Chile
Investigational Site Number 1520001
Talca, Chile
Investigational Site Number 2500001
Bordeaux Cedex, France
Investigational Site Number 2500007
Clamart, France
Investigational Site Number 2500006
La Roche Sur Yon Cedex 9, France
Investigational Site Number 2500002
Nantes, France
Investigational Site Number 2500005
Paris Cedex 18, France
Investigational Site Number 2500003
Strasbourg, France
Investigational Site Number 2500004
Suresnes, France
Investigational Site Number 2760002
Essen, Germany
Investigational Site Number 2760004
Köln, Germany
Investigational Site Number 2760001
Münster, Germany
Investigational site number 3760003
Ashdod, Israel
Investigational Site Number 3760002
Jerusalem, Israel
Investigational Site Number 3760001
Ramat Gan, Israel
Investigational Site Number 3800005
Milano, Italy
Investigational Site Number 3800001
Milano, Italy
Investigational Site Number 3800002
Milano, Italy
Investigational Site Number 3800003
Modena, Italy
Investigational Site Number 3800004
Parma, Italy
Investigational Site Number 3800006
Rozzano, Italy
Investigational Site Number 3920002
Fuchu-Shi, Japan
Investigational Site Number 3920003
Iruma-Gun, Japan
Investigational Site Number 3920001
Kamakura-Shi, Japan
Investigational Site Number 6430003
Moscow, Russian Federation
Investigational Site Number 6430002
Moscow, Russian Federation
Investigational Site Number 6430001
Moscow, Russian Federation
Investigational Site Number 7240003
Barcelona, Spain
Investigational Site Number 7240004
Barcelona, Spain
Investigational Site Number 7240002
Madrid, Spain
Investigational Site Number 7240005
Madrid, Spain
Investigational Site Number 7240001
Madrid, Spain
Clinical Sciences & Operations, Study Director
Sanofi