Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sarilumab COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04327388
Recruitment Status : Recruiting
First Posted : March 31, 2020
Last Update Posted : May 18, 2020
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with severe or critical 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 (NEWS2)
  • 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 patients requiring rescue medication during the 28-day period
  • Evaluate need for admission into intensive care unit (ICU)
  • Evaluate duration of hospitalization (days)
  • The secondary safety objectives of the study are to evaluate the safety of sarilumab through hospitalization (up to day 29 if patient is still hospitalized) compared to the control arm as assessed by incidence of:

    • Serious adverse events (SAEs)
    • Major or opportunistic bacterial or fungal infections in patients with grade 4 neutropenia
    • Grade ≥2 infusion related reactions
    • Grade ≥2 hypersensitivity reactions
    • Increase in alanine transaminase (ALT) ≥3X upper limit of normal (ULN) (for patients with normal baseline) or >3X ULN AND at least 2-fold increase from baseline value (for patients with abnormal baseline)
    • Major or opportunistic bacterial or fungal infections

Condition or disease Intervention/treatment Phase
Corona Virus Infection Drug: Sarilumab SAR153191 Drug: Placebo Phase 3

Detailed Description:
An individual patient will complete the study approximately 60 days from screening to follow-up on day 60 ±7 days.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Adaptive Phase 3, Randomized, Double-blind, Placebo-controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients With COVID19
Actual Study Start Date : March 28, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Sarilumab

Arm Intervention/treatment
Experimental: Sarilumab Dose 1
Sarilumab Dose 1 given intravenously one time on Day 1. Patients may receive a second dose with Sarilumab Dose 1 24 to 48 hours after the first dose.
Drug: Sarilumab SAR153191
Pharmaceutical form:Solution for injection Route of administration: Intravenous infusion
Other Name: REGN88

Experimental: Sarilumab Dose 2
Sarilumab Dose 2 given intravenously one time on Day 1. Patients may receive a second dose with Sarilumab Dose 2 24 to 48 hours after the first dose.
Drug: Sarilumab SAR153191
Pharmaceutical form:Solution for injection Route of administration: Intravenous infusion
Other Name: REGN88

Placebo Comparator: Matching placebo
Matching placebo given intravenously one time on Day 1. Patients may receive a second dose with matching placebo 24 to 48 hours after the first dose.
Drug: Placebo
Pharmaceutical form:Solution for injection Route of administration: Intravenous infusion




Primary Outcome Measures :
  1. Time to improvement of 2 points in clinical status assessment from baseline using the 7-point ordinal scale [ Time Frame: Baseline to Day 29 ]
    The ordinal scale is an assessment of the clinical status. Score ranges 1-7. Lower score is worse.


Secondary Outcome Measures :
  1. Percent of patients alive at Day 29 [ Time Frame: Day 29 ]
  2. Proportion of patients with one point improvement from baseline in clinical status assessment at days 4, 7, 15, 21, 29 using the 7-point ordinal scale [ Time Frame: Baseline to Days 4, 7, 15, 21, 29 ]
    The ordinal scale is an assessment of the clinical status. Score ranges 1-7. Lower score is worse.

  3. Mean change in the 7-point ordinal scale from baseline to Days 4, 7, 15, 21, and 29 (or until discharge) [ Time Frame: Baseline to Days 4, 7, 15, 21, 29 (or until discharge) ]
    The ordinal scale is an assessment of the clinical status. Score ranges 1-7. Lower score is worse.

  4. Time to resolution of fever [ Time Frame: Baseline to Day 29 ]
    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 is sooner.

  5. Time to resolution of fever and improvement in oxygenation [ Time Frame: Baseline to Day 29 ]
    Resolution of both fever and improvement in oxygenation. Resolution of fever is 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 is sooner. Improvement in oxygenation is defined as SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2 for at least 48 hours, or until discharge, whichever is sooner.

  6. Days with fever [ Time Frame: Baseline to Day 29 ]
    Fever is defined as >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.

  7. Time to change in NEWS2 from baseline [ Time Frame: Baseline to Day 29 ]
    The National Early Warning Score (NEWS2) is used to standardize the assessment of acute-illness severity, track the clinical condition of patients, and to alert clinical teams to patient deterioration. Score ranges from 0-20. A higher score is worse.

  8. Time to NEWS2 of <2 and maintained for 24 hours [ Time Frame: Baseline to Day 29 ]
    The NEWS2 is used to standardize the assessment of acute-illness severity, track the clinical condition of patients, and to alert clinical teams to patient deterioration. Score ranges from 0-20. A higher score is worse.

  9. Mean change from baseline to days 4, 7, 15, 21, and 29 in NEWS2 [ Time Frame: Baseline to days 4, 7, 15, 21, and 29 ]
    The NEWS2 is used to standardize the assessment of acute-illness severity, track the clinical condition of patients, and to alert clinical teams to patient deterioration. Score ranges from 0-20. A higher score is worse.

  10. Time-to-improvement in oxygenation [ Time Frame: Baseline to Day 29 ]
    SpO2/FiO2 of 50 or greater compared to the nadir for at least 48 hours, or until discharge, whichever is sooner. SpO2 is oxygen saturation and FiO2 is the fraction of inspired oxygen.

  11. Alive off supplemental oxygen at day 29 [ Time Frame: Day 29 ]
    Supplemental oxygen is defined as oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device.

  12. Days of hypoxemia [ Time Frame: Baseline to Day 29 ]
    Hypoxemia is defined as SpO2 <93% on room air, or requiring supplemental oxygen, or mechanical ventilatory support.

  13. Days of supplemental oxygen use [ Time Frame: Baseline to Day 29 ]
    Supplemental oxygen is defined as oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device.

  14. Days of resting respiratory rate >24 breaths/min [ Time Frame: Baseline to Day 29 ]
  15. Time to saturation ≥94% on room air [ Time Frame: Baseline to Day 29 ]
  16. Ventilator free days in the first 28 days (to day 29) [ Time Frame: Baseline to Day 29 ]
  17. The number of patients with Initiation of mechanical ventilation, non-invasive ventilation, or use of high flow nasal cannula [ Time Frame: Baseline to Day 60 ]
    For those not requiring these interventions at baseline.

  18. Proportion of patients requiring rescue medication during the 28-day period [ Time Frame: Baseline to Day 28 ]
  19. The number of patients transferred to the ICU or the need to transfer to the ICU (if the ICU is not available) [ Time Frame: Baseline to Day 60 ]
    For patients are not in ICU at baseline

  20. Days of hospitalization among survivors [ Time Frame: Baseline to Day 60 ]
  21. Incidence of serious adverse events [ Time Frame: Baseline to Day 60 ]
  22. The incidence of major or opportunistic bacterial or fungal infections [ Time Frame: Baseline to Day 60 ]
  23. The incidence of major or opportunistic bacterial or fungal infections in patients with grade 4 neutropenia [ Time Frame: Baseline to Day 60 ]
  24. The incidence of hypersensitivity reactions, infusion reactions, gastrointestinal perforation [ Time Frame: Baseline to Day 60 ]
  25. The number of patients with clinically significant laboratory abnormalities [ Time Frame: Baseline to Day 60 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 SARS-CoV-2 infection

Exclusion criteria:

Unlikely to survive after 48 hours from screening or unlikely to remain at the investigational site beyond 48 hours. Patients with multi organ dysfunction or requiring extracorporeal life support or renal replacement therapy are excluded.

Presence of neutropenia less than 2000/mmˆ3, aspartate aminotransferase (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 Known or suspected history of tuberculosis Suspected or known active systemic bacterial or fungal infections

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04327388


Contacts
Layout table for location contacts
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com

Locations
Show Show 34 study locations
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Clinical Sciences & Operations Sanofi

Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT04327388    
Other Study ID Numbers: EFC16844
2020-001162-12 ( EudraCT Number )
First Posted: March 31, 2020    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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://www.clinicalstudydatarequest.com/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronavirus Infections
Severe Acute Respiratory Syndrome
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases