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Sarilumab COVID-19

Primary Purpose

Corona Virus Infection

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Sarilumab SAR153191

Placebo

About this trial

This is an interventional treatment trial for Corona Virus Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Sarilumab 200 mg

Sarilumab 400 mg

Placebo

Arm Description

Sarilumab 200 milligrams (mg), single dose of intravenous (IV) injection on Day 1. Participants could receive a second dose of sarilumab 200 mg 24 to 48 hours after the first dose if first and any one of last three criteria was met as compared to Day 1 (as per following protocol amendment 2 [dated 08-Apr-2020]): Benefit risk assessment by the investigator favored the administration of another dose of study drug without compromising safety and Increase/recurrence of fever or Increase/no change in fraction of inspired oxygen (FiO2) requirement or Required vasopressors, extracorporeal membrane oxygenation (ECMO) or development of multi-organ dysfunction.

Sarilumab 400 mg, single dose of IV injection on Day 1. Participants could receive a second dose of sarilumab 400 mg 24 to 48 hours after the first dose if first and any one of last three criteria was met as compared to Day 1 (as per following protocol amendment 2 [dated 08-Apr-2020]): Benefit risk assessment by the investigator favored the administration of another dose of study drug without compromising safety and Increase/recurrence of fever or Increase/no change in FiO2 requirement or Required vasopressors, ECMO or development of multi-organ dysfunction.

Placebo (for sarilumab), single dose of IV injection on Day 1. Participants could receive a second dose of placebo (for sarilumab) 24 to 48 hours after the first dose if first and any one of last three criteria was met as compared to Day 1 (as per following protocol amendment 2 [dated 08-Apr-2020]): Benefit risk assessment by the investigator favored the administration of another dose of study drug without compromising safety and Increase/recurrence of fever or Increase/no change in FiO2 requirement or Required vasopressors, ECMO or development of multi-organ dysfunction.

Outcomes

Primary Outcome Measures

Time to Improvement in Clinical Status of Participants (Using 7-point Ordinal Scale Score) by at Least 2 Points

Time to improvement of greater than or equal (>=) 2 points in clinical status assessment was defined as time (in days) from first dose of study drug to the time of first occurrence of improvement of >=2 points in clinical status of participants assessed using 7-point ordinal scale (calculated as: Date of first occurrence/episode of the event - date of first dose + 1). Seven-point ordinal scale for clinical assessment ranges from 1= death; 2= hospitalized, on invasive mechanical ventilation/ECMO; 3= hospitalized, on non-invasive ventilation/high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5= hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related/otherwise); 6= hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care; 7= not hospitalized, higher score = less severity. Kaplan-Meier method was used for analysis.

Secondary Outcome Measures

Percentage of Participants Who Were Alive at Day 29

Percentage of participants who were alive at Day 29 were reported in this outcome measure.

Percentage of Participants With Improvement in Clinical Status (According to 7-point Ordinal Scale Score) by at Least 1 Point From Baseline at Days 4, 7, 15, 21, and 29

Clinical status of participants was assessed using 7-point ordinal scale ranges from: 1= death; 2= hospitalized, on invasive mechanical ventilation/ECMO; 3= hospitalized, on non-invasive ventilation/high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5= hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related/otherwise); 6= hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care; 7= not hospitalized, higher score=less severity. Percentage of participants With >=1 point improvement in clinical status from Baseline at Days 4, 7, 15, 21, and 29 (assessed using the 7-point ordinal scale) were reported.

Change From Baseline at Days 4, 7, 15, 21, 29 in 7-point Ordinal Scale Score

Time to Resolution of Fever

Resolution of fever was defined as body temperature less than or equal to (<=) 36.6 degree Celsius (°C) (axilla), or <=37.2°C (oral), or <=37.8°C (rectal or tympanic) for at least 48 hours without antipyretics/until discharge, whichever was sooner. Time to resolution of fever (in days) was calculated as: date of first occurrence/episode of the event (resolution of fever) - date of first dose + 1. Kaplan-Meier method was used for estimation.

Time to Resolution of Fever and Improvement in Oxygenation

Time to resolution of fever was defined as body temperature <=36.6°C (axilla), or <=37.2 °C (oral), or <=37.8°C (rectal or tympanic) for at least 48 hours without antipyretics or until discharge, whichever was sooner. Improvement in oxygenation was defined as oxygen saturation (SpO2)/FiO2 of 50 or greater compared to the nadir SpO2/FiO2 for at least 48 hours, or until discharge, whichever was sooner. Nadir SpO2/FiO2 was the nadir (lowest value) at any point in the study. Time to resolution of fever and improvement in oxygenation (in days) was calculated as: date of first occurrence/episode of the event (resolution of fever and improvement in oxygenation) - date of first dose + 1. Kaplan-Meier method was used for estimation.

Number of Days With Fever

Fever was defined as body temperature greater than (>) 37.4°C (axilla), or >38.0 °C (oral), or >38.4°C (rectal or tympanic) based on maximum value observed during a 24-hour period. Number of days with fever were reported. Least square (LS) mean and standard error (SE) were estimated using the analysis of covariance (ANCOVA) model with treatment group and randomization strata as fixed effects.

Percentage of Participants in Each National Early Warning Score 2 (NEWS2) Clinical Risk Category at Baseline and at Days 4, 7, 15, 21, and 29

NEWS2: used to standardize assessment of acute-illness severity, track clinical condition of participants and to alert clinical teams to participant deterioration. NEWS2 score was based on 7 clinical parameters: respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse rate, level of consciousness, and temperature. A score of 0, 1, 2, and 3 was allocated to each parameter except supplemental oxygen (a score of 0 or 1 was allocated) and level of consciousness (a score of 0 or 3 was allocated), where 0 = normal health condition to 3 = worst health condition; higher score indicated more severity. All scores were summed to get an aggregate score. Aggregate NEWS2 score ranged from 0 to 19, with higher scores meaning more severity/higher risk. Percentage of participants in following clinical risk categories were reported: low risk (score 0 to 4); low to medium risk (score of 3 in any individual parameter); medium risk (score 5 to 6); high risk (score 7 to 19).

Time to National Early Warning Score of Less Than (<) 2 and Maintained for 24 Hours

Time to NEWS2 <2 and maintained for 24 hours: time (in days) from 1st dose of study drug until 1st occurrence of NEWS score of <2 (maintained for 24 hours); calculated as: date of 1st occurrence/episode of event (NEWS score of <2) - date of 1st dose + 1. NEWS2 score was based on 7 clinical parameters: respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse rate, level of consciousness, and temperature. A score of 0, 1, 2, and 3 was allocated to each parameter except supplemental oxygen (score of 0 or 1 was allocated) and level of consciousness (score of 0 or 3 was allocated), where 0=normal health condition to 3=worst health condition; higher score=more severity. All scores were summed to get an aggregate score which ranged from 0 to 19, with higher scores=more severity/higher risk. Kaplan-Meier method was used for analysis.

Change From Baseline at Days 4, 7, 15, 21, and 29 in National Early Warning Score 2

The NEWS2 was used to standardize the assessment of acute-illness severity, track the clinical condition of participants, and to alert clinical teams to participant deterioration. NEWS2 score is based on 7 clinical parameters: respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse rate, level of consciousness, and temperature. A score of 0, 1, 2, and 3 was allocated to each parameter except supplemental oxygen (a score of 0 or 1 was allocated) and level of consciousness (a score of 0 or 3 was allocated), where 0 = normal health condition to 3 = worst health condition; higher score indicated more severity. All scores were summed to get an aggregate score. Aggregate NEWS2 score ranged from 0 to 19, with higher scores meaning more severity/higher risk. LS means and SE were estimated using ANCOVA model with treatment group and randomization strata as fixed effects, and baseline NEWS2 score as a covariate.

Time-to-improvement in Oxygenation

Time-to-improvement in oxygenation was defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2 for at least 48 hours or until discharge, whichever was sooner. Nadir SpO2/FiO2 was the nadir (lowest value) at any point in the study. Time to improvement in oxygenation was calculated as: date of first occurrence/episode of the event (oxygenation) - date of first dose + 1. Kaplan-Meier method was used for estimation.

Percentage of Participants Alive Off Supplemental Oxygen at Day 29

Supplemental oxygen was defined as oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device.

Percentage of Days With Hypoxemia

Hypoxemia (low level of oxygen in the blood) was defined as SpO2 <93% on room air, or required supplemental oxygen, or mechanical ventilatory support. Days meeting the criteria for hypoxemia since the first study dose were counted and the percentage of days with hypoxemia were calculated as:100*number of days with the hypoxemia divided by number of days of follow up (defined as the earlier date of death or discharge or last visit up to Day 29). LS mean and SE were estimated using the ANCOVA model with treatment group and randomization strata as fixed effects.

Percentage of Days With Supplemental Oxygen Use

Supplemental oxygen (oxygen therapy) was defined as oxygen administration using oxygen delivery device (e.g. nasal cannula, simple face mask, non-rebreather mask, high flow nasal cannula, non-invasive ventilation, invasive mechanical ventilation, extracorporeal life support, etc.). Days meeting the criteria for supplemental oxygen use since the first study dose were counted and the percentage of days with supplemental oxygen use were calculated as:100*number of days with the supplemental oxygen use divided by number of days of follow up (defined as the earlier date of death or discharge or last visit up to Day 29) . LS mean and SE were estimated using the ANCOVA model with treatment group and randomization strata as fixed effects.

Percentage of Days With Resting Respiratory Rate > 24 Breaths Per Minute

Resting respiratory rate was measured in terms of number of breaths per minute (bpm) while a person is at rest. Only the days with respiratory rate >24 breath per minute since the first dose were counted and percentage of days with respiratory rate > 24 bpm were calculated as:100*number of days with respiratory rate >24 bpm divided by number of days of follow up (defined as the earlier date of death or discharge or last visit up to Day 29). LS mean and SE were estimated using the ANCOVA model with treatment group and randomization strata as fixed effects.

Time to Oxygen Saturation >= 94% on Room Air

Time to oxygen saturation >=94% on room air was defined as the time (in days) from first dose of study drug until the time of first occurrence of oxygen saturation >=94% and it was calculated as: Date of first occurrence/episode of the event (oxygen saturation >=94%) - date of first dose + 1.Kaplan-Meier method was used for estimation.

Mean Number of Ventilator Free Days

Mean number of ventilator free days in participants were reported.

Percentage of Participants With Initiation of Mechanical Ventilation, Non-invasive Ventilation, or Use of High Flow Nasal Cannula

Percentage of participants With initiation of mechanical ventilation or non-invasive ventilation, or use of high flow nasal cannula were reported in this outcome measure.

Percentage of Participants Who Required Rescue Medication

Rescue medications were defined as the immunosuppressive (methylprednisolone, dexamethasone and prednisone) therapies. During the course of the study, participant who required rescue therapy was based on the judgement of the study physician.

Percentage of Participants Who Needed Intensive Care Unit (ICU) Care During Study

Percentage of participants who needed ICU care until Day 29 were reported for those not in an ICU at baseline.

Number of Days of Hospitalization Among Survivors (Alive Participants)

Number of days of hospitalization among alive participants were counted at Day 60 since the first dose. LS mean and SE were estimated using the ANCOVA model with treatment group and randomization strata as fixed effects.

Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)

An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. Treatment-emergent AEs (TEAEs) were the AEs that developed or worsened or became serious during the TEAE period (from the time of first dose of study drug to the last dose of study drug + 60 days). SAEs were any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event.

Number of Participants With Major or Opportunistic Bacterial or Fungal Infections

Major or opportunistic bacterial or fungal infections was considered as an adverse event of special interest (AESI: defined as an AE [serious or non-serious] of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required).

Number of Participants With Grade 4 Neutropenia and Grade 4 Neutropenia With Concurrent Invasive Infection

Grade 4 neutropenia was defined as participants with absolute neutrophil count (ANC) <500 per cubic millimeter (mm^3). Grade 4 neutropenia with concurrent invasive infection was defined as infections and infestations (in participants with Grade 4 neutropenia) within 1 week of ANC <500/mm^3 and was considered as an AESI (defined as an AE [serious or non-serious] of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required).

Number of Participants With Grade >=2 Infusion Reactions, Grade >=2 Hypersensitivity Reactions and Gastrointestinal Perforation

Grade >=2 (moderate) infusion related reactions (defined as any TEAE signs or symptoms experienced by participants who received study medication within 24 hours of the start of infusion) and Grade >=2 (moderate) hypersensitivity reactions (anaphylactic reaction, hypersensitivity or angioedema and moderate reactions) were considered as AESI which was defined as an AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required. Gastrointestinal Perforation was defined as formation of a hole through the stomach, large bowel or small intestine.

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Hematological Parameter - Hemoglobin, Leukocytes and Platelets

Criteria for PCSA: Hemoglobin: less than or equal to (<=) 115 grams per liter (g/L) (male) and <=95 g/L (female); greater than or equal to (>=) 185 g/L (male) and >=165 g/L (female); and decrease from baseline >=20 g/L. Leukocytes: <3.0*10^9/Liters (L) (Non-Black) or <2.0*10^9/L (black); >=16.0*10^9/L. Platelets: < 100*10^9/L; >=700*10^9/L.

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters

Criteria for PCSA: Creatinine: >=150 micromoles per liter (mcmol/L); >=30% change from baseline; >= 100% change from baseline.

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters

Alanine Aminotransferase (ALT): >3 upper limit of normal (ULN); >5 ULN; >10 ULN and >20 ULN. Bilirubin: >1.5 ULN; >2 ULN.

Full Information

NCT ID

NCT04327388

First Posted

March 26, 2020

Last Updated

March 15, 2022

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04327388

Brief Title

Sarilumab COVID-19

Official Title

An Adaptive Phase 3, Randomized, Double-blind, Placebo-controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients With COVID19

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

March 28, 2020 (Actual)

Primary Completion Date

July 31, 2020 (Actual)

Study Completion Date

September 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed Description

An individual participant would complete the study approximately 60 days from screening to follow-up on day 60 ±7 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Corona Virus Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

420 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sarilumab 200 mg

Arm Type

Experimental

Arm Description

Arm Title

Sarilumab 400 mg

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Sarilumab SAR153191

Other Intervention Name(s)

REGN88, Kevzara®

Intervention Description

Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion

Primary Outcome Measure Information:

Title

Time to Improvement in Clinical Status of Participants (Using 7-point Ordinal Scale Score) by at Least 2 Points

Description

Time Frame

Baseline to Day 29

Secondary Outcome Measure Information:

Title

Percentage of Participants Who Were Alive at Day 29

Description

Percentage of participants who were alive at Day 29 were reported in this outcome measure.

Time Frame

Day 29

Title

Percentage of Participants With Improvement in Clinical Status (According to 7-point Ordinal Scale Score) by at Least 1 Point From Baseline at Days 4, 7, 15, 21, and 29

Description

Time Frame

Baseline, Days 4, 7, 15, 21, and 29

Title

Change From Baseline at Days 4, 7, 15, 21, 29 in 7-point Ordinal Scale Score

Description

Time Frame

Baseline, Days 4, 7, 15, 21, and 29

Title

Time to Resolution of Fever

Description

Time Frame

Baseline to Day 29

Title

Time to Resolution of Fever and Improvement in Oxygenation

Description

Time Frame

Baseline to Day 29

Title

Number of Days With Fever

Description

Time Frame

Baseline to Day 29

Title

Percentage of Participants in Each National Early Warning Score 2 (NEWS2) Clinical Risk Category at Baseline and at Days 4, 7, 15, 21, and 29

Description

Time Frame

Baseline, Days 4, 7, 15, 21, and 29

Title

Time to National Early Warning Score of Less Than (<) 2 and Maintained for 24 Hours

Description

Time Frame

Baseline to Day 29

Title

Change From Baseline at Days 4, 7, 15, 21, and 29 in National Early Warning Score 2

Description

Time Frame

Baseline, Days 4, 7, 15, 21, and 29

Title

Time-to-improvement in Oxygenation

Description

Time Frame

Baseline to Day 29

Title

Percentage of Participants Alive Off Supplemental Oxygen at Day 29

Description

Supplemental oxygen was defined as oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device.

Time Frame

Day 29

Title

Percentage of Days With Hypoxemia

Description

Time Frame

Baseline to Day 29

Title

Percentage of Days With Supplemental Oxygen Use

Description

Time Frame

Baseline to Day 29

Title

Percentage of Days With Resting Respiratory Rate > 24 Breaths Per Minute

Description

Time Frame

Baseline to Day 29

Title

Time to Oxygen Saturation >= 94% on Room Air

Description

Time Frame

Baseline to Day 29

Title

Mean Number of Ventilator Free Days

Description

Mean number of ventilator free days in participants were reported.

Time Frame

Baseline to Day 29

Title

Percentage of Participants With Initiation of Mechanical Ventilation, Non-invasive Ventilation, or Use of High Flow Nasal Cannula

Description

Percentage of participants With initiation of mechanical ventilation or non-invasive ventilation, or use of high flow nasal cannula were reported in this outcome measure.

Time Frame

Baseline to Day 29

Title

Percentage of Participants Who Required Rescue Medication

Description

Time Frame

Baseline to Day 28

Title

Percentage of Participants Who Needed Intensive Care Unit (ICU) Care During Study

Description

Percentage of participants who needed ICU care until Day 29 were reported for those not in an ICU at baseline.

Time Frame

Baseline to Day 29

Title

Number of Days of Hospitalization Among Survivors (Alive Participants)

Description

Time Frame

At Day 60

Title

Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)

Description

Time Frame

Baseline up to 60 days

Title

Number of Participants With Major or Opportunistic Bacterial or Fungal Infections

Description

Time Frame

Baseline up to 60 days

Title

Number of Participants With Grade 4 Neutropenia and Grade 4 Neutropenia With Concurrent Invasive Infection

Description

Time Frame

Baseline up to 60 days

Title

Number of Participants With Grade >=2 Infusion Reactions, Grade >=2 Hypersensitivity Reactions and Gastrointestinal Perforation

Description

Time Frame

Baseline up to 60 days

Title

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Hematological Parameter - Hemoglobin, Leukocytes and Platelets

Description

Time Frame

Baseline up to 60 days

Title

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters

Description

Criteria for PCSA: Creatinine: >=150 micromoles per liter (mcmol/L); >=30% change from baseline; >= 100% change from baseline.

Time Frame

Baseline up to 60 days

Title

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters

Description

Alanine Aminotransferase (ALT): >3 upper limit of normal (ULN); >5 ULN; >10 ULN and >20 ULN. Bilirubin: >1.5 ULN; >2 ULN.

Time Frame

Baseline up to 60 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 0320001

City

Caba

ZIP/Postal Code

1430

Country

Argentina

Facility Name

Investigational Site Number 0320003

City

Caba

ZIP/Postal Code

C1180AAX

Country

Argentina

Facility Name

Investigational Site Number 0320004

City

Caba

ZIP/Postal Code

C1426AAM

Country

Argentina

Facility Name

Investigational Site Number 0760003

City

Porto Alegre

ZIP/Postal Code

90110-270

Country

Brazil

Facility Name

Investigational Site Number 0760001

City

Sao Paulo

ZIP/Postal Code

01327-001

Country

Brazil

Facility Name

Investigational Site Number 0760002

City

Sao Paulo

ZIP/Postal Code

04231-030

Country

Brazil

Facility Name

Investigational Site Number 0760004

City

São José Do Rio Preto

ZIP/Postal Code

15090-000

Country

Brazil

Facility Name

Investigational Site Number 0760005

City

São Paulo

ZIP/Postal Code

04321-120

Country

Brazil

Facility Name

Investigational Site Number 1240001

City

Montreal

ZIP/Postal Code

H2X3E4

Country

Canada

Facility Name

Investigational Site Number 1240005

City

Montreal

ZIP/Postal Code

H4A 3J1

Country

Canada

Facility Name

Investigational Site Number 1240004

City

Toronto

ZIP/Postal Code

M4N3M5

Country

Canada

Facility Name

Investigational Site Number 1240002

City

Toronto

ZIP/Postal Code

M5G 2N2

Country

Canada

Facility Name

Investigational Site Number 1240003

City

Vancouver

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

Investigational Site Number 1520003

City

Santiago

ZIP/Postal Code

750-0691

Country

Chile

Facility Name

Investigational Site Number 1520002

City

Santiago

ZIP/Postal Code

80004005

Country

Chile

Facility Name

Investigational Site Number 1520004

City

Santiago

Country

Chile

Facility Name

Investigational Site Number 1520001

City

Talca

ZIP/Postal Code

3460001

Country

Chile

Facility Name

Investigational Site Number 2500001

City

Bordeaux Cedex

ZIP/Postal Code

33076

Country

France

Facility Name

Investigational Site Number 2500007

City

Clamart

ZIP/Postal Code

92140

Country

France

Facility Name

Investigational Site Number 2500006

City

La Roche Sur Yon Cedex 9

ZIP/Postal Code

85925

Country

France

Facility Name

Investigational Site Number 2500002

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

Investigational Site Number 2500005

City

Paris Cedex 18

ZIP/Postal Code

75877

Country

France

Facility Name

Investigational Site Number 2500003

City

Strasbourg

ZIP/Postal Code

67098

Country

France

Facility Name

Investigational Site Number 2500004

City

Suresnes

ZIP/Postal Code

92151

Country

France

Facility Name

Investigational Site Number 2760002

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Investigational Site Number 2760004

City

Köln

ZIP/Postal Code

50937

Country

Germany

Facility Name

Investigational Site Number 2760001

City

Münster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Investigational site number 3760003

City

Ashdod

ZIP/Postal Code

7747629

Country

Israel

Facility Name

Investigational Site Number 3760002

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Investigational Site Number 3760001

City

Ramat Gan

ZIP/Postal Code

52662

Country

Israel

Facility Name

Investigational Site Number 3800005

City

Milano

ZIP/Postal Code

20122

Country

Italy

Facility Name

Investigational Site Number 3800001

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Investigational Site Number 3800002

City

Milano

ZIP/Postal Code

20157

Country

Italy

Facility Name

Investigational Site Number 3800003

City

Modena

ZIP/Postal Code

41100

Country

Italy

Facility Name

Investigational Site Number 3800004

City

Parma

ZIP/Postal Code

43100

Country

Italy

Facility Name

Investigational Site Number 3800006

City

Rozzano

ZIP/Postal Code

20089

Country

Italy

Facility Name

Investigational Site Number 3920002

City

Fuchu-Shi

Country

Japan

Facility Name

Investigational Site Number 3920003

City

Iruma-Gun

Country

Japan

Facility Name

Investigational Site Number 3920001

City

Kamakura-Shi

Country

Japan

Facility Name

Investigational Site Number 6430003

City

Moscow

ZIP/Postal Code

111539

Country

Russian Federation

Facility Name

Investigational Site Number 6430002

City

Moscow

ZIP/Postal Code

123182

Country

Russian Federation

Facility Name

Investigational Site Number 6430001

City

Moscow

ZIP/Postal Code

129301

Country

Russian Federation

Facility Name

Investigational Site Number 7240003

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Investigational Site Number 7240004

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Investigational Site Number 7240002

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Investigational Site Number 7240005

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Investigational Site Number 7240001

City

Madrid

ZIP/Postal Code

28046

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Citations:

PubMed Identifier

33676590

Citation

Lescure FX, Honda H, Fowler RA, Lazar JS, Shi G, Wung P, Patel N, Hagino O; Sarilumab COVID-19 Global Study Group. Sarilumab in patients admitted to hospital with severe or critical COVID-19: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2021 May;9(5):522-532. doi: 10.1016/S2213-2600(21)00099-0. Epub 2021 Mar 4.

Results Reference

derived

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Sarilumab COVID-19

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Sarilumab COVID-19

Corona Virus Infection

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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