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

Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 May 2021

At a glance

  • Drugs Sarilumab (Primary)
  • Indications COVID-19 pneumonia
  • Focus Registrational; Therapeutic Use
  • Sponsors Sanofi
  • Most Recent Events

    • 07 Sep 2020 Status changed from active, no longer recruiting to completed.
    • 01 Sep 2020 According to a Sanofi media release, detailed results from the study will be submitted to a peer-reviewed publication later in 2020.
    • 01 Sep 2020 Results published in the Sanofi Media Release.

Trial Overview

Outcome

Primary endpoint not met - negative

Purpose

To evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with severe or critical COVID-19

Primary Endpoints

Not met, 01 Sep 2020

Time to improvement of 2 points in clinical status assessment from baseline using the 7-point ordinal scale

description: The ordinal scale is an assessment of the clinical status. Score ranges 1-7. Lower score is worse.
time_frame: Baseline to Day 29 [1]

Other Endpoints

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

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: 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.
time_frame: Baseline, Days 4, 7, 15, 21, and 29

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

description: 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.
time_frame: Baseline, Days 4, 7, 15, 21, and 29

Time to Resolution of Fever

description: 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_frame: Baseline to Day 29

Time to Resolution of Fever and Improvement in Oxygenation

description: 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.
time_frame: Baseline to Day 29

Number of Days With Fever

description: 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.
time_frame: Baseline to Day 29

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

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

description: 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.
time_frame: Baseline to Day 29

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

description: 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_frame: Baseline, Days 4, 7, 15, 21, and 29

Time-to-improvement in Oxygenation

description: 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.
time_frame: Baseline to Day 29

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

Percentage of Days With Hypoxemia

description: 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.
time_frame: Baseline to Day 29

Percentage of Days With Supplemental Oxygen Use

description: 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.
time_frame: Baseline to Day 29

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

description: 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_frame: Baseline to Day 29

Time to Oxygen Saturation ≥ 94% on Room Air

description: 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.
time_frame: Baseline to Day 29

Mean Number of Ventilator Free Days

description: Mean number of ventilator free days in participants were reported.
time_frame: Baseline to Day 29

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

Percentage of Participants Who Required Rescue Medication

description: 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.
time_frame: Baseline to Day 28

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

Number of Days of Hospitalization Among Survivors (Alive Participants)

description: 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.
time_frame: At Day 60

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

description: 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.
time_frame: Baseline up to 60 days

Number of Participants With Major or Opportunistic Bacterial or Fungal Infections

description: 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).
time_frame: Baseline up to 60 days

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

description: 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).
time_frame: Baseline up to 60 days

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

description: 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.
time_frame: Baseline up to 60 days

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

description: 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.
time_frame: Baseline up to 60 days

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

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 [2]

Diseases Treated

Indication Qualifiers Patient Segments
COVID-19 pneumonia treatment severe

Subjects

  • Subject Type patients
  • Number

    Planned: 460

    Actual: 420

  • Sex male & female
  • Age Group ≥ 18 years; adult; elderly

Patient Inclusion 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.

Patient 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.

Trial Details

Identifiers

Identifier Owner
NCT04327388 ClinicalTrials.gov: US National Institutes of Health
EudraCT2020-001162-12 European Clinical Trials Database
EFC16844 Sanofi
U1111-1249-6021 World Health Organisation

Organisations

  • Sponsors Sanofi
  • Affiliations Regeneron Pharmaceuticals; Sanofi

Trial Dates

  • Initiation Dates

    Planned : 29 Mar 2020

    Actual : 28 Mar 2020

  • Primary Completion Dates

    Planned : 01 Jul 2020

    Actual : 31 Jul 2020

  • End Dates

    Planned : 01 Aug 2020

    Actual : 02 Sep 2020

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • Phase of Trial Phase III
  • Location Argentina; Brazil; Canada; Chile; France; Germany; Israel; Italy; Japan; Russia; Spain
  • Focus Registrational; Therapeutic Use

Interventions

Drugs Route Formulation
SarilumabPrimary Drug Intravenous Infusion, Injection

Sarilumab 200 mg

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. Drug: Sarilumab SAR153191 (Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion) Other Name: REGN88, Kevzara®

Sarilumab 400 mg

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. Drug: Sarilumab SAR153191 (Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion) Other Name: REGN88, Kevzara®

Placebo

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. Drug: Placebo (Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion)

Results

Therapeutic efficacy

Updated results from a phase III trial in patients with COVID-2019 infections, showed potential effect in sicker population post treatment with sarilumab with a 9% mortality reduction reported in ventilated patients, although not statistically significant. Earlier data showed that treatment with sarilumab led to numerical trends toward a decrease in duration of hospital stay as well as an acceleration in time to improve clinical outcomes, as measured by a 2-point improvement from baseline on the 7-point scale. Time to discharge was shortened by 2-3 days (statistically non-significant) within the first two weeks [3] [1] .

Adverse events

In a phase III trial, serious adverse events were reported in 26-29% treated with sarilumab and 24% of placebo patients with COVID-2019 infections. The incidence of adverse events leading to death was reported in 10% in all three treatment arms. Serious infections (including COVID-19 pneumonia) was reported in 11-13% of sarilumab patients and 12% of placebo patients [1] .

Publications

  1. Sanofi. Sanofi provides update on Kevzara(Rm) (sarilumab) Phase 3 trial in severe and critically ill COVID-19 patients outside the U.S. Media-Rel 2020;.

    Media Release

Authors

Author Total Publications First Author Last Author
Sanofi 1 1 1

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Clinical Sciences & Operations
Trial Transparency email recommended (Toll free number for US & Canada)
800-633-1610 Ext: option 6
Contact-US@sanofi.com
show details
Sanofi
-
CONTACT POINT
VIALE BODIO, 37/B,
MILANO, 20158, Italy
Tel:800226343
Fax:00290239394168
informazioni.medicoscientifiche@sanofi.com
show details
SANOFI S.P.A. Italy
Direction des Operations Cliniques
1 avenue Pierre Brossolette,
Chilly-Mazarin, 91385,
France.
Public-Registry-MA-France@sanofi.com
show details
Sanofi-aventis France France

Centres

Centre Name Location Trial Centre Country
- Ashdod Israel
- Barcelona Spain
- Bordeaux Cedex France
- Caba Argentina
- Clamart France
- Essen Germany
- Fuchu-Shi Japan
- Iruma-Gun Japan
- Jerusalem Israel
- Köln Germany
- Kamakura-Shi Japan
- La Roche Sur Yon Cedex 9 France
- Münster Germany
- Madrid Spain
- Milano Italy
- Modena Italy
- Montreal Canada
- Moscow Russia
- Nantes France
- Paris Cedex 18 France
- Parma Italy
- Porto Alegre Brazil
- Ramat Gan Israel
- Rozzano Italy
- São José Do Rio Preto Brazil
- São Paulo Brazil
- Santiago Chile
- Sao Paulo Brazil
- Strasbourg France
- Suresnes France
- Talca Chile
- Toronto Canada
- Vancouver Canada
Regeneron Pharmaceuticals
-
-
Sanofi
-
-
SANOFI S.P.A. MILANO Italy
Sanofi-Aventis Deutschland GmbH
medinfo.de@sanofi.com
show details
-
Germany
Sanofi-aventis France Chilly-Mazarin France
Sanofi-aventis Recherche et Developpement
-
France

Trial History

Event Date Event Type Comment
19 May 2021 Other trial event Last checked against ClinicalTrials.gov record. Updated 19 May 2021
27 Oct 2020 Other trial event Last checked against European Clinical Trials Database record. Updated 27 Oct 2020
07 Sep 2020 Status change - completed Status changed from active, no longer recruiting to completed. Updated 10 Sep 2020
01 Sep 2020 Other trial event According to a Sanofi media release, detailed results from the study will be submitted to a peer-reviewed publication later in 2020. Updated 03 Sep 2020
01 Sep 2020 Results Results published in the Sanofi Media Release. Updated 03 Sep 2020
01 Sep 2020 Endpoint not met Primary endpoint has not been met. (Time to improvement of 2 points in clinical status assessment from baseline using the 7-point ordinal scale), according to a Sanofi media release. Updated 03 Sep 2020
15 Jul 2020 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting. Updated 20 Jul 2020
14 May 2020 Other trial event This trial has been suspended in Germany as per European Clinical Trials Database record. Updated 14 May 2020
09 May 2020 Protocol amendment Phase changed from phase II/III to Phase III. Number of patients changed to 400. Arms, outcome measures and eligibility criteria amended. Updated 13 May 2020
06 May 2020 Completion date Planned End Date changed from 1 Jun 2021 to 1 Aug 2020. Updated 08 May 2020
27 Apr 2020 Other trial event According to a Sanofi media release, amendments similar to US Phase II/III trial will be considered for this trial. Updated 05 May 2020
27 Apr 2020 Other trial event According to a Regeneron Pharmaceuticals media release, initial results from this trial are expected in the third quarter of 2020. Updated 29 Apr 2020
07 Apr 2020 Other trial event Planned initiation date changed from 28 Mar 2020 to 29 Mar 2020. Updated 13 Apr 2020
02 Apr 2020 Other trial event New source identified and integrated (ClinicalTrials.gov: US National Institutes of Health;NCT04327388 ) Updated 02 Apr 2020
01 Apr 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 03 Apr 2020
30 Mar 2020 Other trial event According to a Sanofi media release, both the companies (Sanofi and Regeneron Pharmaceuticals) are continuing to work with health authorities around the world to secure initiation at additional sites. Updated 31 Mar 2020
30 Mar 2020 Other trial event According to a Sanofi media release, the first patient outside of the U.S. has been treated in this trial, as part of a global clinical program evaluating Kevzara (sarilumab) in patients hospitalized with severe COVID-19. Updated 31 Mar 2020
27 Mar 2020 Other trial event New Source identified and integrated(European Clinical Trials Database:EudraCT2020-001162-12) Updated 27 Mar 2020
25 Mar 2020 Status change - recruiting Status changed from planning to recruiting. Updated 27 Mar 2020
20 Mar 2020 New trial record New trial record Updated 20 Mar 2020
16 Mar 2020 Other trial event According to a Regeneron Pharmaceuticals media release, Sanofi expect to rapidly initiate trials outside the U.S. in the coming weeks, including areas most affected by the pandemic such as Italy. Updated 20 Mar 2020
16 Mar 2020 Other trial event According to a Regeneron Pharmaceuticals media release, Regeneron Pharmaceuticals and Sanofi have started a clinical program evaluating Kevzara (sarilumab) in patients hospitalized with severe COVID-19 infection.Regeneron is leading U.S. trials, Sanofi will lead this upcoming ex-U.S. trial. Updated 20 Mar 2020

References

  1. Sanofi. Sanofi provides update on Kevzara(Rm) (sarilumab) Phase 3 trial in severe and critically ill COVID-19 patients outside the U.S. Media-Rel 2020;.

    Media Release
  2. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2021;.

    Available from: URL: http://clinicaltrials.gov
  3. Sanofi. Sanofi Q3 2020 business EPS(1) growth of 8.8% at CER. Media-Rel 2020;.

    Media Release
  4. Regeneron Pharmaceuticals, Sanofi. Regeneron and Sanofi Provide Update on U.S. Phase 2/3 Adaptive-Designed Trial of Kevzara(Rm) (sarilumab) in Hospitalized COVID-19 Patients. Media-Rel 2020;.

    Media Release
  5. European Clinical Trials Database. Trial-Reg 2021;.

    Available from: URL: https://www.clinicaltrialsregister.eu
  6. Sanofi. Sanofi and Regeneron provide update on U.S. Phase 2/3 adaptive-designed trial in hospitalized COVID-19 patients. Media-Rel 2020;.

    Media Release
  7. Regeneron Pharmaceuticals, Sanofi. Regeneron and Sanofi Begin Global Kevzara(R) (sarilumab) Clinical Trial Program in Patients with Severe COVID-19. Media-Rel 2020;.

    Media Release
  8. Regeneron Pharmaceuticals. First patient outside U.S. treated in global Kevzara(Rm) (sarilumab) clinical trial program for patients with severe COVID-19. Media-Rel 2020;.

    Media Release
  9. Sanofi. Sanofi: First patient outside U.S. treated in global Kevzara(Rm) (sarilumab) clinical trial program for patients with severe COVID-19. Media-Rel 2020;.

    Media Release
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