Sarilumab COVID-19
Condition: Corona Virus Infection
MeSH terms: Coronavirus Infections
Intervention: Sarilumab SAR153191; Placebo
Intervention description: Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion; Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 420.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.