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Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04315298
Recruitment Status : Completed
First Posted : March 19, 2020
Last Update Posted : October 1, 2020
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE March 15, 2020
First Posted Date  ICMJE March 19, 2020
Last Update Posted Date October 1, 2020
Actual Study Start Date  ICMJE March 18, 2020
Actual Primary Completion Date July 24, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2020)
  • Percent change in C-reactive protein (CRP) levels in patients with serum IL-6 level greater than the upper limit of normal [ Time Frame: Day 4 ]
    Phase 2
  • Proportion of patients with at least 1-point improvement in clinical status using the 7-point ordinal scale in patients with critical COVID-19 receiving mechanical ventilation at baseline [ Time Frame: Up to day 22 ]
    Phase 3 Cohort 1 7-point Ordinal Scale:
    • Death;
    • Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO);
    • Hospitalized, requiring non-invasive ventilation or high flow oxygen devices;
    • Hospitalized, requiring supplemental oxygen;
    • Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
    • Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
    • Not hospitalized
  • Proportion of patients with at least 1-point improvement in clinical status using the 7-point ordinal scale in patients with COVID-19 receiving mechanical ventilation at baseline [ Time Frame: Up to day 22 ]
    Phase 3 Cohort 2
Original Primary Outcome Measures  ICMJE
 (submitted: March 17, 2020)
  • Time to resolution of fever for at least 48 hours without antipyretics for 48 hours [ Time Frame: Up to day 29 ]
    Phase 2 Defined as ≤36.6°C (axilla), ≤37.2°C (oral) or ≤37.8°C (rectal or tympanic)
  • Percentage of patients reporting each severity rating on a 6-point ordinal scale [ Time Frame: Day 15 ]
    Phase 3 6-point Ordinal Scale:
    1. Death
    2. Hospitalized, on invasive mechanical ventilation or ECMO;
    3. Hospitalized, on non-invasive ventilation or high flow oxygen devices;
    4. Hospitalized, requiring supplemental oxygen
    5. Hospitalized, not requiring supplemental oxygen
    6. Not hospitalized
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2020)
  • Time to improvement (2 points) in clinical status assessment on the 7-point ordinal scale in severe or critical patients with serum IL-6 levels greater than the upper limit of normal [ Time Frame: Up to day 29 ]
    Phase 2
  • Time to improvement (2 points) in clinical status assessment on the 7-point ordinal scale reporting in severe or critical patients with all IL-6 levels [ Time Frame: Up to day 29 ]
    Phase 2
  • Time to resolution of fever for at least 48 hours without antipyretics in patients with documented fever [ Time Frame: Up to day 29 ]
    Phase 2 Resolution of fever defined as postbaseline body temperature <37.2°C (oral), or <37.6°C (rectal or tympanic) or <36.8°C (temporal or axillary) Documented fever defined as ≥38°C (oral), ≥38.4°C (rectal or tympanic), or ≥37.6°C (temporal or axillary)
  • Time to resolution of fever for at least 48 hours without antipyretics by clinical severity [ Time Frame: Up to day 29 ]
    Phase 2 Defined as postbaseline body temperature <37.2°C (oral), or <37.6°C (rectal or tympanic) or <36.8°C (temporal or axillary)
  • Time to resolution of fever for at least 48 hours without antipyretics by baseline IL-6 levels [ Time Frame: Up to day 29 ]
    Phase 2 Defined as postbaseline body temperature <37.2°C (oral), or <37.6°C (rectal or tympanic) or <36.8°C (temporal or axillary)
  • Time to improvement in oxygenation for at least 48 hours [ Time Frame: Up to day 29 ]
    Phase 2 Improvement in oxygenation defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2
  • Time to improvement in oxygenation for at least 48 hours by clinical severity [ Time Frame: Up to day 29 ]
    Phase 2 Defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2
  • Time to improvement in oxygenation for at least 48 hours by baseline IL-6 levels [ Time Frame: Up to day 29 ]
    Phase 2 Defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2
  • Time to resolution of fever and improvement in oxygenation for at least 48 hours [ Time Frame: Up to day 29 ]
    Phase 2 Resolution of fever defined as postbaseline body temperature <37.2°C (oral), or <37.6°C (rectal or tympanic) or <36.8°C (temporal or axillary) Improvement in oxygenation defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2
  • Mean change in the 7-point ordinal scale [ Time Frame: Up to day 29 ]
    Phase 2
  • Percentage of patients in each clinical status category using the 7-point ordinal scale [ Time Frame: Up to day 29 ]
    Phase 2
  • Time to discharge or to a National Early Warning Score 2 (NEWS2) of ≤2 and maintained for 24 hours [ Time Frame: Up to day 29 ]
    Phase 2 NEWS2 consists of: Physiological Parameters: Respiration rate (per minute), SpO2 Scale 1 (%), SpO2 Scale 2 (%), Use of Air or oxygen, Systolic blood pressure (mmHg), Pulse (per minute), Consciousness, Temperature (°C)
  • Change from baseline in NEWS2 scoring system [ Time Frame: Up to day 29 ]
    Phase 2
  • Number of days with fever [ Time Frame: Up to day 29 ]
    Phase 2 Defined as ≥38°C (oral), ≥38.4°C (rectal or tympanic) or ≥37.6°C (temporal or axillary)
  • Proportion of patients alive, off oxygen [ Time Frame: At day 29 ]
    Phase 2
  • Number of days of resting respiratory rate >24 breaths/min [ Time Frame: Up to day 29 ]
    Phase 2
  • Number of days with hypoxemia [ Time Frame: Up to day 29 ]
    Phase 2
  • Number of days of supplemental oxygen use [ Time Frame: Up to day 29 ]
    Phase 2
  • Time to saturation ≥94% on room air [ Time Frame: Up to day 29 ]
    Phase 2
  • Number of ventilator free days in the first 28 days [ Time Frame: Baseline to day 29 ]
    Phase 2
  • Number of patients requiring initiation of mechanical ventilation [ Time Frame: Up to day 29 ]
    Phase 2
  • Number of patients requiring non-invasive ventilation [ Time Frame: Up to day 29 ]
    Phase 2
  • Number of patients requiring the use of high flow nasal cannula [ Time Frame: Up to day 29 ]
    Phase 2
  • Number of patients admitted into an intensive care unit (ICU) [ Time Frame: Up to day 29 ]
    Phase 2
  • Number of days of hospitalization among survivors [ Time Frame: Up to day 29 ]
    Phase 2
  • Number of deaths due to any cause [ Time Frame: Up to day 60 ]
    Phase 2
  • Proportion of patients with at least 1-point improvement in clinical status using the 7-point ordinal scale [ Time Frame: Up to day 22 ]
    Phase 3
  • Proportion of patients who recover [ Time Frame: Up to day 22 ]
    Phase 3 Defined as discharged, or alive without supplemental oxygen use or at pre-COVID oxygen use
  • Proportion of deaths [ Time Frame: Through day 29 ]
    Phase 3
  • Proportion of patients alive not receiving mechanical ventilation [ Time Frame: At day 22 ]
    Phase 3
  • Proportion of patients alive not requiring extracorporeal membrane oxygenation (ECMO) [ Time Frame: At day 22 ]
    Phase 3
  • Proportion of patients with a 2-point improvement in clinical status on the 7-point ordinal scale [ Time Frame: Up to day 22 ]
    Phase 3
  • Time to at least 1-point improvement in clinical status assessment on the 7-point ordinal scale [ Time Frame: Up to day 29 ]
    Phase 3
  • Time to at least 2-point improvement in clinical status assessment on the 7-point ordinal scale [ Time Frame: Up to day 29 ]
    Phase 3
  • Proportion of patients receiving mechanical ventilation [ Time Frame: Up to day 22 ]
    Phase 3
  • Proportion of patients receiving ECMO [ Time Frame: Up to day 22 ]
    Phase 3
  • Proportion of patients discharged and alive [ Time Frame: At day 22 ]
    Phase 3
  • Time to recovery [ Time Frame: Up to day 29 ]
    Phase 3 Defined as discharged or alive without supplemental oxygen use or at pre-COVID oxygen use
  • Proportion of deaths [ Time Frame: Through day 60 ]
    Phase 3
  • Time to death due to any cause [ Time Frame: Through day 60 ]
    Phase 3
  • Number of ventilator free days [ Time Frame: Up to day 29 ]
    Phase 3
  • Number of days of hospitalization among survivors [ Time Frame: Up to day 29 ]
    Phase 3
  • Proportion of patients with serious adverse events [ Time Frame: Up to Day 29 ]
    Phase 2 and Phase 3
  • Proportion of patients with Grade 4 neutropenia (ANC <500/mm3) [ Time Frame: Up to day 29 ]
    Phase 2 and Phase 3
  • Proportion of patients with severe or life-threatening bacterial, invasive fungal, or opportunistic infection [ Time Frame: Up to day 29 ]
    Phase 2 and Phase 3
  • Proportion of patients with severe or life-threatening bacterial, invasive fungal, or opportunistic infection in patients with Grade 4 neutropenia (ANC <500/mm3) [ Time Frame: Up to day 29 ]
    Phase 2 and Phase 3
  • Proportion of patients with hypersensitivity reactions [ Time Frame: Up to day 29 ]
    Phase 2 and Phase 3
  • Proportion of patients with infusion reactions [ Time Frame: Up to day 29 ]
    Phase 2 and Phase 3
  • Proportion of patients with gastrointestinal perforation [ Time Frame: Up to day 29 ]
    Phase 2 and Phase 3
  • White blood cell count [ Time Frame: Up to day 29 if still hospitalized ]
    Phase 2 and Phase 3
  • Hemoglobin levels [ Time Frame: Up to day 29 if still hospitalized ]
    Phase 2 and Phase 3
  • Platelet count [ Time Frame: Up to day 29 if still hospitalized ]
    Phase 2 and Phase 3
  • Creatinine levels [ Time Frame: Up to day 29 if still hospitalized ]
    Phase 2 and Phase 3
  • Total bilirubin level [ Time Frame: Up to day 29 if still hospitalized ]
    Phase 2 and Phase 3
  • Alanine aminotransferase (ALT) level [ Time Frame: Up to day 29 if still hospitalized ]
    Phase 2 and Phase 3
  • Aspartate aminotransferase (AST) level [ Time Frame: Up to day 29 if still hospitalized ]
    Phase 2 and Phase 3
Original Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2020)
  • Time to improvement in oxygenation for at least 48 hours [ Time Frame: Up to day 29 ]
    Increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2
  • Mean change in the 6-point ordinal scale [ Time Frame: Up to day 29 ]
    6-point Ordinal Scale:
    1. Death
    2. Hospitalized, on invasive mechanical ventilation or ECMO;
    3. Hospitalized, on non-invasive ventilation or high flow oxygen devices;
    4. Hospitalized, requiring supplemental oxygen
    5. Hospitalized, not requiring supplemental oxygen
    6. Not hospitalized
  • Clinical status using the 6-point ordinal scale [ Time Frame: Up to day 29 ]
    6-point Ordinal Scale:
    1. Death
    2. Hospitalized, on invasive mechanical ventilation or ECMO;
    3. Hospitalized, on non-invasive ventilation or high flow oxygen devices;
    4. Hospitalized, requiring supplemental oxygen
    5. Hospitalized, not requiring supplemental oxygen
    6. Not hospitalized
  • Time to improvement in one category from admission using the 6-point ordinal scale [ Time Frame: Up to day 29 ]
    6-point Ordinal Scale:
    1. Death
    2. Hospitalized, on invasive mechanical ventilation or ECMO;
    3. Hospitalized, on non-invasive ventilation or high flow oxygen devices;
    4. Hospitalized, requiring supplemental oxygen
    5. Hospitalized, not requiring supplemental oxygen
    6. Not hospitalized
  • Time to resolution of fever for at least 48 hours without antipyretics by clinical severity [ Time Frame: Up to day 29 ]
    Defined as ≤36.6°C (axilla), ≤37.2°C (oral) or ≤37.8°C (rectal or tympanic)
  • Time to resolution of fever for at least 48 hours without antipyretics by baseline IL-6 levels [ Time Frame: Up to day 29 ]
    Defined as ≤36.6°C (axilla), ≤37.2°C (oral) or ≤37.8°C (rectal or tympanic)
  • Time to improvement in oxygenation for at least 48 hours by clinical severity [ Time Frame: Up to day 29 ]
    Increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2
  • Time to improvement in oxygenation for at least 48 hours by baseline IL-6 levels [ Time Frame: Up to day 29 ]
    Increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2
  • Time to resolution of fever and improvement in oxygenation for at least 48 hours [ Time Frame: Up to day 29 ]
    Resolution of fever defined as Defined as ≤36.6°C (axilla), ≤37.2°C (oral) or ≤37.8°C (rectal or tympanic). Improvement in oxygenation defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2
  • Time to change in National Early Warning Score 2 (NEWS2) scoring system [ Time Frame: Up to day 29 ]
    NEWS2 consists of: Physiological Parameters: Respiration rate (per minute), SpO2 Scale 1 (%), SpO2 Scale 2 (%), Use of Air or oxygen, Systolic blood pressure (mmHg), Pulse (per minute), Consciousness, Temperature (°C)
  • Time to score of <2 maintained for 24 hours in NEWS2 scoring system [ Time Frame: Up to day 29 ]
    NEWS2 consists of: Physiological Parameters: Respiration rate (per minute), SpO2 Scale 1 (%), SpO2 Scale 2 (%), Use of Air or oxygen, Systolic blood pressure (mmHg), Pulse (per minute), Consciousness, Temperature (°C)
  • Mean change in NEWS2 scoring system [ Time Frame: Up to day 29 ]
    NEWS2 consists of: Physiological Parameters: Respiration rate (per minute), SpO2 Scale 1 (%), SpO2 Scale 2 (%), Use of air or oxygen, Systolic blood pressure (mmHg), Pulse (per minute), Consciousness, Temperature (°C)
  • Number of days with fever [ Time Frame: Up to day 29 ]
    Defined as >36.6°C (axilla), >37.2°C (oral) or >37.8°C (rectal or tympanic)
  • Number of patients alive off oxygen [ Time Frame: Day 29 ]
  • Number of days of resting respiratory rate >24 breaths/min [ Time Frame: Up to day 29 ]
  • Number of days with hypoxemia [ Time Frame: Up to day 29 ]
  • Number of days of supplemental oxygen use [ Time Frame: Up to day 29 ]
  • Time to saturation ≥94% on room air [ Time Frame: Up to day 29 ]
  • Number of ventilator free days in the first 28 days [ Time Frame: Baseline to day 29 ]
  • Number of patients requiring initiation of mechanical ventilation [ Time Frame: Up to day 29 ]
  • Number of patients requiring non-invasive ventilation [ Time Frame: Up to day 29 ]
  • Number of patients requiring the use of high flow nasal cannula [ Time Frame: Up to day 29 ]
  • Number of patients admitted into an intensive care unit (ICU) [ Time Frame: Up to day 29 ]
  • Number of days of hospitalization among survivors [ Time Frame: Up to day 29 ]
  • Number of deaths due to any cause [ Time Frame: Up to day 60 ]
  • Incidence of serious adverse events [ Time Frame: Up to day 60 ]
  • Incidence of severe or life-threatening bacterial, invasive fungal, or opportunistic infection [ Time Frame: Up to day 29 ]
  • Incidence of severe or life-threatening bacterial, invasive fungal, or opportunistic infection in patients with Grade 4 neutropenia [ Time Frame: Up to day 60 ]
  • Incidence of hypersensitivity reactions [ Time Frame: Up to day 29 ]
  • Incidence of infusion reactions [ Time Frame: Up to day 29 ]
  • Incidence of gastrointestinal perforation [ Time Frame: Up to day 60 ]
  • White blood cell count [ Time Frame: Up to day 29 if still hospitalized ]
  • Hemoglobin levels [ Time Frame: Up to day 29 if still hospitalized ]
  • Platelet count [ Time Frame: Up to day 29 if still hospitalized ]
  • Creatinine levels [ Time Frame: Up to day 29 if still hospitalized ]
  • Total bilirubin level [ Time Frame: Up to day 29 if still hospitalized ]
  • Alanine aminotransferase level [ Time Frame: Up to day 29 if still hospitalized ]
  • Aspartate aminotransferase level [ Time Frame: Up to day 29 if still hospitalized ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19
Official Title  ICMJE An Adaptive Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients With COVID-19
Brief Summary

Phase 2:

The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with COVID-19 regardless of disease severity strata.

Phase 3 Cohort 1:

The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with critical COVID-19 receiving mechanical ventilation at baseline.

Phase 3 Cohort 2:

The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with COVID-19 receiving mechanical ventilation at baseline.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: Sarilumab
    Single or multiple intravenous (IV) doses of sarilumab. Additional doses may be administered if the patient meets protocol defined criteria.
    Other Names:
    • Kevzara®
    • REGN88
    • SAR153191
  • Drug: Placebo
    Single or multiple intravenous (IV) doses of placebo to match sarilumab administration
Study Arms  ICMJE
  • Experimental: Sarilumab low dose (P2)
    Phase 2
    Interventions:
    • Drug: Sarilumab
    • Drug: Placebo
  • Experimental: Sarilumab low dose (P3:C1)
    Phase 3: Cohort 1
    Interventions:
    • Drug: Sarilumab
    • Drug: Placebo
  • Experimental: Sarilumab mid dose (P2)
    Phase 2
    Interventions:
    • Drug: Sarilumab
    • Drug: Placebo
  • Experimental: Sarilumab mid dose (P3:C1)
    Phase 3: Cohort 1
    Interventions:
    • Drug: Sarilumab
    • Drug: Placebo
  • Experimental: Sarilumab high dose (P3:C2)
    Phase 3: Cohort 2
    Interventions:
    • Drug: Sarilumab
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2020)
1912
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2020)
400
Actual Study Completion Date  ICMJE September 2, 2020
Actual Primary Completion Date July 24, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR), result from any specimen (or other commercial or public health assay) within 2 weeks prior to randomization and no alternative explanation for current clinical condition
  • Hospitalized with illness of any duration with evidence of pneumonia, requires supplemental oxygen and/or assisted ventilation and meets one of the following:
  • Phase 2 and Phase 3 Cohort 1:

Meets 1 of the following criteria at baseline:

  • Severe disease or
  • Critical disease or
  • Multi-system organ dysfunction or
  • Immunocompromised
  • Phase 3 Cohort 2:

Patients must be receiving mechanical ventilation to treat respiratory failure due to COVID-19

  • Ability to provide informed consent signed by study patient or legally acceptable representative
  • Willingness and ability to comply with study-related procedures/assessments

Key Exclusion Criteria:

  • In the opinion of the investigator, not expected to survive for more than 48 hours from screening
  • Presence of any of the following abnormal laboratory values at screening: absolute neutrophil count (ANC) less than 2000 mm3, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 x upper limit of normal (ULN), platelets <50,000 per mm3
  • Treatment with anti-IL 6, anti-IL-6R antagonists, or with Janus kinase inhibitors (JAKi) in the past 30 days or plans to receive during the study period
  • Current treatment with the simultaneous combination of leflunomide and methotrexate
  • Known active tuberculosis (TB), history of incompletely treated TB, suspected or known extrapulmonary TB, suspected or known systemic bacterial or fungal infections
  • Participation in a double-blind clinical research study evaluating an investigational product (IP) or therapy within 3 months and less than 5 half-lives of IP prior to the screening visit (The use of remdesivir, hydroxychloroquine, or other treatments being used for COVID-19 treatments in the context of an open-label study, Emergency Use Authorization (EUA), compassionate use protocol or open-label use is permitted)
  • Any physical examination findings, and/or history of any illness, concomitant medications or recent live vaccines that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study
  • Known systemic hypersensitivity to sarilumab or the excipients of the drug product
  • Phase 3 Cohort 2 only:
  • Known or suspected history of immunosuppression or immunodeficiency disorder
  • Patients who require renal replacement therapy for acute kidney injury at randomization or who required renal replacement therapy within 72 hours prior to randomization
  • Patients who have circulatory shock requiring vasopressors at randomization or within 24 hours prior to randomization
  • Use of extracorporeal life support (eg, ECMO) or, in the opinion of the investigator, there is a high likelihood that extracorporeal life support will be initiated within 48 hours after randomization

NOTE: Other protocol defined inclusion / exclusion criteria may apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04315298
Other Study ID Numbers  ICMJE 6R88-COV-2040
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All IPD that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification
Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, EMA, PMDA, etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
URL: https://vivli.org/
Responsible Party Regeneron Pharmaceuticals
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP