Sarilumab COVID-19

An adaptive phase 2/3, randomized, double-blind, placebo-controlled, study assessing efficacy and safety of sarilumab for hospitalized patients with COVID19

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001162-12-FR

Enrollment

460

Registered

2020-03-20

Start date

2020-03-26

Completion date

Unknown

Last updated

2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corona virus infection MedDRA version: 23.0 Level: LLT Classification code 10053983 Term: Corona virus infection System Organ Class: 100000004862

Interventions

Trade Name: Kevzara® Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: SARILUMAB Current Sponsor code: SAR153191 Concentration unit: mg milligram(s) Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants must have severe disease, multi-system organ dysfunction or critical disease Laboratory-confirmed SARS-CoV-2 infection Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 184 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 276

Exclusion criteria

Exclusion criteria: Unlikely to survive for >48 hours from screening Presence of neutropenia less than 2000/mmˆ3, AST or ALT greater than 5 X ULN, platelets less than 50,000/mmˆ3 Prior immunosuppressive therapies Use of chronic oral corticosteroids for non-COVID-19 related condition Past or current history of autoimmune or inflammatory disease(s) Known or suspected history of tuberculosis Suspected or known active systemic bacterial or fungal infections

Design outcomes

Primary

Measure	Time frame
Main Objective: Phase 2: To evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with severe COVID-19 Phase 3: To evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with severe or critical COVID-19 ;Secondary Objective: Evaluate the clinical efficacy of sarilumab compared to the control arm by clinical severity, changes in the National Early Warning Score 2, duration of predefined symptoms and signs, duration of supplemental oxygen dependency, incidence of new mechanical ventilation use, the duration of new mechanical ventilation use, need for admission into ICU, duration of hospitalization, 28-day mortality rate. Secondary safety objectives are to evaluate the safety of sarilumab compared to the control arm as assessed by incidence of: SAEs, Grade 4 neutropenia (ANC3X ULN and at least 2-fold increase from baseline value (for patients with abnormal baseline), Invasive bacterial or fungal infections of clinical significance with confirmed diagnosis ;Primary end point(s): Phase 2: time to resolution of fever for at least 48 hours without antipyretics or until discharge, whichever is sooner Phase 3: The percentage of patients reporting each severity rating on the 7-point ordinal scale;Timepoint(s) of evaluation of this end point: Baseline to Day 29	—

Measure

Time frame

Main Objective: Phase 2: To evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with severe COVID-19 Phase 3: To evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with severe or critical COVID-19 ;Secondary Objective: Evaluate the clinical efficacy of sarilumab compared to the control arm by clinical severity, changes in the National Early Warning Score 2, duration of predefined symptoms and signs, duration of supplemental oxygen dependency, incidence of new mechanical ventilation use, the duration of new mechanical ventilation use, need for admission into ICU, duration of hospitalization, 28-day mortality rate. Secondary safety objectives are to evaluate the safety of sarilumab compared to the control arm as assessed by incidence of: SAEs, Grade 4 neutropenia (ANC3X ULN and at least 2-fold increase from baseline value (for patients with abnormal baseline), Invasive bacterial or fungal infections of clinical significance with confirmed diagnosis ;Primary end point(s): Phase 2: time to resolution of fever for at least 48 hours without antipyretics or until discharge, whichever is sooner Phase 3: The percentage of patients reporting each severity rating on the 7-point ordinal scale;Timepoint(s) of evaluation of this end point: Baseline to Day 29

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Secondary

Measure	Time frame
Secondary end point(s): Phase 2 1- The time to improvement in oxygenation 2- Mean change in 7-point ordinal scale from baseline to Day 15 3- Clinical status using the 7-point ordinal scale at Day 15 4- Time to improvement of two categories from admission using the 7-point ordinal Phase 2 and 3 5- Time to resolution of fever 6- Time to improvement in oxygenation 7- Time to resolution of fever and improvement in oxygenation 8- Time to change in NEWS2 from baseline 9- Time to NEWS2 of 24 breaths/min 14- Days of hypoxemia 15- Days of supplemental oxygen use 16- Time to saturation =94% on room air 17- Ventilator free days in the first 28 days (to day 29) 18- The number of patients with Initiation of mechanical ventilation, non-invasive ventilation, or use of high flow nasal cannula 19- The number of patients transferred to the ICU or the need to transfer to the ICU (if the ICU is not available) 20- Days of hospitalization among survivors 21- Incidence of death Phase 3 22- Mean change in the 7-point ordinal scale from baseline to days 3, 5, 8, 11, 15, and 29 (or until discharge) 23- Clinical status using the 7-point ordinal scale at days 3, 5, 8, 11,15, and 29 24- Time to improvement of two categories from admission using the 7-point ordinal scale Phase 2 and 3 25- Incidence of serious adverse events 26- The incidence of major or opportunistic bacterial or fungal infections 27- The incidence of major or opportunistic bacterial or fungal infections in patients with grade 4 neutropenia 28- The incidence of hypersensitivity reactions, infusion reactions, gastrointestinal perforation 29- The number of patients with clinically significant laboratory abnormalities.;Timepoint(s) of evaluation of this end point: 1, 4 to 9, 11 to 17, 24 : Baseline to Day 29 2-3 : Baseline to Day 15 10 : Baseline to Days 3, 5, 8, 11, 15 and 29 18 to 21, 25 to 29 : Baseline to Day 60 22 : Baseline to days 3, 5, 8, 11, 15, and 29 (or until discharge) 23 : Days 3, 5, 8, 11,15, and 29	—

Measure

Time frame

Secondary end point(s): Phase 2 1- The time to improvement in oxygenation 2- Mean change in 7-point ordinal scale from baseline to Day 15 3- Clinical status using the 7-point ordinal scale at Day 15 4- Time to improvement of two categories from admission using the 7-point ordinal Phase 2 and 3 5- Time to resolution of fever 6- Time to improvement in oxygenation 7- Time to resolution of fever and improvement in oxygenation 8- Time to change in NEWS2 from baseline 9- Time to NEWS2 of 24 breaths/min 14- Days of hypoxemia 15- Days of supplemental oxygen use 16- Time to saturation =94% on room air 17- Ventilator free days in the first 28 days (to day 29) 18- The number of patients with Initiation of mechanical ventilation, non-invasive ventilation, or use of high flow nasal cannula 19- The number of patients transferred to the ICU or the need to transfer to the ICU (if the ICU is not available) 20- Days of hospitalization among survivors 21- Incidence of death Phase 3 22- Mean change in the 7-point ordinal scale from baseline to days 3, 5, 8, 11, 15, and 29 (or until discharge) 23- Clinical status using the 7-point ordinal scale at days 3, 5, 8, 11,15, and 29 24- Time to improvement of two categories from admission using the 7-point ordinal scale Phase 2 and 3 25- Incidence of serious adverse events 26- The incidence of major or opportunistic bacterial or fungal infections 27- The incidence of major or opportunistic bacterial or fungal infections in patients with grade 4 neutropenia 28- The incidence of hypersensitivity reactions, infusion reactions, gastrointestinal perforation 29- The number of patients with clinically significant laboratory abnormalities.;Timepoint(s) of evaluation of this end point: 1, 4 to 9, 11 to 17, 24 : Baseline to Day 29 2-3 : Baseline to Day 15 10 : Baseline to Days 3, 5, 8, 11, 15 and 29 18 to 21, 25 to 29 : Baseline to Day 60 22 : Baseline to days 3, 5, 8, 11, 15, and 29 (or until discharge) 23 : Days 3, 5, 8, 11,15, and 29

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Countries

Canada, France, Germany, Israel, Italy, Japan, Russian Federation, Spain

Contacts

Public ContactDirection des Opérations Cliniques

Sanofi-aventis France

Public-Registry-MA-France@sanofi.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026