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OpenTrials
Completed

NCT Number: NCT04315298

Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Regeneron Study Site, Los Angeles, California, United States

Loading trial locations.

About this study

Phase 2 and Phase 3 Cohort 1 completed. Cohorts 2 and 3 terminated early based on Phase 3 Cohort 1 results.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Phase 3 Cohort 3:

Patients must be receiving supplemental oxygen to treat hypoxemia delivered by one of the following devices:

  • Non-rebreather mask, OR
  • High-flow device with at least 50% FiO2, OR
  • Non-invasive positive pressure ventilator
  • 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 and Cohort 3 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

Treatment and study plan

Sarilumab

Drug

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

Placebo

Drug

Single or multiple intravenous (IV) doses of placebo to match sarilumab administration

Primary outcomes

  1. Percent Change From Baseline in CRP Levels at Day 4 in Participants With Serum IL-6 Level Greater Than the ULN (Phase 2)

    Time frame: Baseline and Day 4

    Percent Change from Baseline in C-Reactive Protein (CRP) Levels at Day 4 in Participants with Serum Interleukin 6 (IL-6) Level Greater than the Upper Limit of Normal (ULN) Least Squares (LS) means estimate of percent change from baseline at Day 4 (raw scale) for each treatment group is based on the Analysis of Covariance (ANCOVA) model. It is defined as anti-log of the estimate of dependent variable minus 1, i.e., (exp[ln(CRP at day 4/Baseline CRP)]-1. Negative numbers imply improvement in CRP.

  2. Percentage of Participants With at Least a 1-point Improvement in Clinical Status From Baseline to Day 22 Using the 7-point Ordinal Scale in Participants With Critical COVID-19 Receiving Mechanical Ventilation at Baseline (Phase 3 Cohort 1)

    Time frame: Day 22

    The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows:

    • Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity

  3. Percentage of Participants With at Least 1-point Improvement in Clinical Status Using the 7-point Ordinal Scale in Participants With COVID-19 Receiving Mechanical Ventilation at Baseline (Phase 3 Cohort 2)

    Time frame: Day 22

    The ordinal scale is an assessment of the clinical status of a participant The 7-point ordinal scale is as follows:

    • Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity

Secondary outcomes

  1. Time to Improvement (2 Points) in Clinical Status Assessment in Severe or Critical Patients With Serum IL-6 Levels Greater Than the Upper Limit of Normal (Phase 2)

    Time frame: Up to Day 29

    Time to improvement (2 points) in clinical status assessment on the 7-point ordinal scale in severe or critical participants with serum IL-6 levels greater than the upper limit of normal (ULN). The ordinal scale is an assessment of the clinical status of a patient. The 7-point ordinal scale is as follows:

    • Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity

  2. Time to Improvement (2 Points) in Clinical Status Assessment in Severe or Critical Patients With All Serum IL-6 Levels (Phase 2)

    Time frame: Up to Day 29

    Time to improvement (2 points) in clinical status assessment on the 7-point ordinal scale in severe or critical participants with all serum IL-6 levels.

    The 7-point ordinal scale is as follows:

    • Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity

  3. Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, in Patients With Documented Fever at Baseline (Phase 2)

    Time frame: Up to Day 29

    Time to resolution of fever for at least 48 hours without antipyretics or until discharge, whichever is sooner, in patients with documented fever ≥38°C (oral), ≥38.4°C (rectal or tympanic), or ≥37.6°C (temporal or axillary) at Baseline.

    Resolution of fever is defined as postbaseline body temperature <37.2°C (oral), or <37.6°C (rectal or tympanic) or <36.8°C (temporal or axillary).

  4. Time to Resolution of Fever for at Least 48 Hours Without Antipyretics by Clinical Severity (Phase 2)

    Time frame: Up to day 29

    Resolution of fever is defined as body temperature <=36.8 C (axilla or temporal) or<= 37.2 C (oral) or <37.6 C (rectal or tympanic) for at least 48 hours without antipyretics or until discharge.

    Resolution of fever is defined only in participants with presence of fever at baseline.

  5. Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, by Baseline IL-6 Levels (Phase 2)

    Time frame: Up to Day 29

    Resolution of fever is defined as body temperature <=36.8 C (axilla or temporal) or<= 37.2 C (oral) or <37.6 C (rectal or tympanic) for at least 48 hours without antipyretics or until discharge, by baseline IL-6 levels.

    Resolution of fever is defined only in participants with presence of fever at baseline.

  6. Time to Improvement in Oxygenation for at Least 48 Hours (Phase 2)

    Time frame: Up to day 29

    Improvement in oxygenation defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2

  7. Time to Improvement in Oxygenation for at Least 48 Hours by Baseline IL-6 Levels (Phase 2)

    Time frame: Up to day 29

    Time to Improvement defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2

  8. Time to Resolution of Fever and Improvement in Oxygenation for at Least 48 Hours (Phase 2)

    Time frame: Up to day 29

    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

  9. Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)

    Time frame: Days 1, 3, 5, 8, 11, 15 and 29

    Percentage of participants in each clinical status category using the 7-point ordinal scale from Baseline (Day 1) up to Day 29. The 7-point ordinal scale is as follows:

    • Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity

  10. Time to Discharge or to a National Early Warning Score 2 (NEWS2) of ≤2 and Maintained for 24 Hours (Phase 2)

    Time frame: Up to day 29

    NEWS2 was 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: 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).

  11. Change From Baseline in NEWS2 Scoring System (Phase 2)

    Time frame: Days 3, 5, 8, 11, 15 and 29

    NEWS2 was 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: 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).

  12. Number of Days With Fever (Phase 2)

    Time frame: Up to Day 29

    Defined as ≥38°C (oral), ≥38.4°C (rectal or tympanic) or ≥37.6°C (temporal or axillary)

  13. Percentage of Participants Alive, Off Oxygen (Phase 2)

    Time frame: At Day 29

  14. Number of Days of Resting Respiratory Rate >24 Breaths/Min (Phase 2)

    Time frame: Up to day 29

  15. Number of Days With Hypoxemia (Phase 2)

    Time frame: Up to day 29

  16. Number of Days of Supplemental Oxygen Use (Phase 2)

    Time frame: Up to day 29

  17. Time to Saturation ≥94% on Room Air (Phase 2)

    Time frame: Up to day 29

  18. Number of Ventilator Free Days (Phase 2)

    Time frame: Up to Day 22

    Summary of Ventilator-free days during study in Participants using Invasive Mechanical Ventilation at Baseline

  19. Number of Participants Who Initiated Mechanical Ventilation After Baseline (Phase 2)

    Time frame: Up to Day 29

  20. Number of Days in an Intensive Care Unit (ICU) in Participants Who Were Not in ICU at Baseline (Phase 2)

    Time frame: Up to Day 29

  21. Number of Days of Hospitalization Among Survivors (Phase 2)

    Time frame: Up to day 29

  22. Number of Deaths Due to Any Cause

    Time frame: Up to day 60

    Number of deaths due to any cause (All-Cause Mortality)

  23. Percentage of Participants With at Least 1-point Improvement in Clinical Status Using the 7-point Ordinal Scale in Participants With Critical COVID-19 (Phase 3 Cohort 1: Critical ITT)

    Time frame: Day 22

    The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows:

    • Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity

  24. Percentage of Participants Who Recover (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)

    Time frame: Day 22

    Percentage of Participants Who Recover (Discharged, or Alive without Supplemental Oxygen Use or at Pre-COVID Oxygen Use) at Day 22

  25. Percentage of Participants Who Recover (Phase 3 Cohort 1: Critical ITT)

    Time frame: Day 22

    Percentage of Participants Who Recover (Discharged, or Alive without Supplemental Oxygen Use or at Pre-COVID Oxygen Use) at Day 22

  26. Percentage of Participants Who Die (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)

    Time frame: Up to Day 29 and Day 60

    Percentage of Participants who die through Day 29 and Day 60

  27. Percentage of Participants Who Die (Phase 3 Cohort 1: Critical ITT)

    Time frame: Up to Day 29 and Day 60

    Percentage of Participants who die through Day 29 and Day 60

  28. Percentage of Participants Alive Not Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)

    Time frame: At Day 22

    Percentage of participants alive not receiving mechanical ventilation or ECMO at Day 22 (Phase 3 Cohort 1)

  29. Percentage of Participants With at Least a 2-point Improvement in Clinical Status From Baseline to Day 22 Using the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)

    Time frame: At Day 22

    Percentage of participants with at least a 2-point improvement in clinical status from baseline to Day 22 using the 7-point ordinal scale. The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows:

    • Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity

  30. Percentage of Participants Alive Not Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical ITT)

    Time frame: At Day 22

    Percentage of participants alive not receiving mechanical ventilation or ECMO at Day 22 (Phase 3 Cohort 1)

  31. Percentage of Participants With at Least a 2-point Improvement in Clinical Status From Baseline to Day 22 Using the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical ITT)

    Time frame: At Day 22

    Percentage of participants with at least a 2-point improvement in clinical status from baseline to Day 22 using the 7-point ordinal scale. The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows:

    • Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity

  32. Time to at Least 1-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)

    Time frame: Up to day 29

    The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows:

    • Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity

  33. Time to at Least 1-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical ITT)

    Time frame: Up to day 29

    The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows:

    • Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity

  34. Time to at Least 1-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 2)

    Time frame: Up to day 29

    The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows:

    • Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity

  35. Time to at Least 2-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1)

    Time frame: Up to day 29

    The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows:

    • Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity

  36. Time to at Least 2-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical ITT)

    Time frame: Up to day 29

    The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows:

    • Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity

  37. Percentage of Participants Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)

    Time frame: Day 22

  38. Percentage of Participants Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical ITT)

    Time frame: Day 22

  39. Percentage of Patients Discharged and Alive (Phase 3 Cohort 1)

    Time frame: At Day 22

    Percentage of Patients Discharged and Alive at Day 22

  40. Percentage of Participants Discharged and Alive at Day 22 (Phase 3 Cohort 1: Critical ITT)

    Time frame: At Day 22

    Percentage of Participants Discharged and Alive at Day 22

  41. Time to Recovery (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)

    Time frame: Up to day 29

    Phase 3 Cohort 1 Time to Recovery (Discharged, or Alive without Supplemental Oxygen Use or at Pre-COVID Oxygen Use)

  42. Time to Recovery (Phase 3 Cohort 1: Critical ITT)

    Time frame: Up to day 29

    Phase 3 Cohort 1 Time to Recovery (Discharged, or Alive without Supplemental Oxygen Use or at Pre-COVID Oxygen Use)

  43. Time to Recovery (Phase 3 Cohort 2)

    Time frame: Up to day 29

    Time to Recovery (Discharged, or Alive without Supplemental Oxygen Use or at Pre-COVID Oxygen Use)

  44. Time to Death (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)

    Time frame: Up to day 60

    Phase 3 Cohort 1 Time to Death (All-Cause Mortality)

  45. Time to Death (Phase 3 Cohort 1: Critical ITT)

    Time frame: Up to day 60

    Time to Death (All-Cause Mortality)

  46. Time to Death (Phase 3 Cohort 2)

    Time frame: Up to day 60

    Time to Death (All-Cause Mortality)

  47. Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)

    Time frame: Days 8, 15, 22 and 29

    Number of Ventilator-Free days up to Day 29 (Phase 3 Cohort 1)

  48. Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical ITT)

    Time frame: Days 8, 15, 22 and 29

    Number of Ventilator-Free days up to Day 29 (Phase 3 Cohort 1)

  49. Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1)

    Time frame: Days 8, 15, 22 and 29

    Number of days of hospitalization among survivors (Phase 3 Cohort 1)

  50. Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1: Critical ITT)

    Time frame: Days 8, 15, 22 and 29

    Number of days of hospitalization among survivors (Phase 3 Cohort 1: Critical ITT population)

  51. Number of Participants With Any Serious Adverse Event

    Time frame: Up to day 60

  52. Number of Participants With Grade 4 Neutropenia (ANC <500/mm3)

    Time frame: Up to day 60

    Grade 4 Neutropenia defined as Absolute Neutrophil Count (ANC) of less than 500 per cubic millimeter(mm3)

  53. Number of Participants With Severe or Life-threatening Bacterial, Invasive Fungal, or Opportunistic Infection

    Time frame: Up to day 60

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

    Time frame: Up to day 60

  55. Number of Participants With Grade >=2 Infusion Related Reactions

    Time frame: Up to day 60

  56. Number of Participants With Grade >=2 Hypersensitivity Reactions

    Time frame: Up to day 60

  57. Number of Participants With Gastrointestinal Perforation

    Time frame: Up to day 60

  58. Mean Observed Leukocyte Values Across Study Days (Phase 2)

    Time frame: Days 1, 4, 15 and 29

  59. Mean Observed Leukocyte Values Across Study Days (Phase 3)

    Time frame: Days 1, 4, 15 and 29

  60. Mean Observed Hemoglobin Values Across Study Days (Phase 2)

    Time frame: Days 1, 4, 15 and 29

  61. Mean Observed Hemoglobin Values Across Study Days (Phase 3)

    Time frame: Days 1, 4, 15 and 29

  62. Mean Observed Platelet Count Across Study Days (Phase 2)

    Time frame: Days 1, 4, 15 and 29

  63. Mean Observed Platelet Count Across Study Days (Phase 3)

    Time frame: Days 1, 4, 15 and 29

  64. Mean Observed Total Bilirubin Values Across Study Days (Phase 2)

    Time frame: Days 1, 4, 15 and 29

  65. Mean Observed Total Bilirubin Across Study Days (Phase 3)

    Time frame: Days 1, 4, 15 and 29

  66. Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 2)

    Time frame: Days 1, 4, 15 and 29

  67. Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3)

    Time frame: Days 1, 4, 15 and 29

  68. Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 2)

    Time frame: Days 1, 4, 15 and 29

  69. Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3)

    Time frame: Days 1, 4, 15 and 29

  70. Mean Observed Creatinine Values Across Study Days (Phase 2)

    Time frame: Days 1, 4, 15 and 29

  71. Mean Observed Creatinine Values Across Study Days (Phase 3)

    Time frame: Days 1, 4, 15 and 29

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

  • Sanofi

Registry information

Official study title

An Adaptive Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients With COVID-19

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 19, 2020
Registry last updated
Sep 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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