COVID-19Phase 2/3NCT04315298
Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19
A Phase 2/3 study testing Sarilumab in people with COVID-19, run by Regeneron Pharmaceuticals at 62 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Sarilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,912 participants
- Where
- 62 sitesUnited States
- Study dates
- 18 Mar 2020to 2 Sep 2020
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
62 sites in 1 country.
62 sites in 1 country
United States62 sites
Regeneron Study Site
Ann Arbor, Michigan, 48109
Regeneron Study Site
Atlanta, Georgia, 30322
Regeneron Study Site
Aurora, Colorado, 80045
Regeneron Study Site
Boston, Massachusetts, 02111
Regeneron Study Site
Boston, Massachusetts, 02114
Regeneron Study Site
Boston, Massachusetts, 02215
Regeneron Study Site
Brooklyn, New York, 11219
Regeneron Study Site
Buffalo, New York, 14263
Regeneron Study Site
Chicago, Illinois, 60611
Regeneron Study Site
Chicago, Illinois, 60612
Regeneron Study Site
Dallas, Texas, 75246
Regeneron Study Site
Dallas, Texas, 75390
Regeneron Study Site
Danville, Pennsylvania, 17822
Regeneron Study Site
Decatur, Georgia, 30033
Regeneron Study Site
Denver, Colorado, 80206
Regeneron Study Site
Edison, New Jersey, 08820
Regeneron Study Site
Elmhurst, New York, 11373
Regeneron Study Site
Everett, Washington, 98201
Regeneron Study Site
Falls Church, Virginia, 22042
Regeneron Study Site
Gainesville, Florida, 32610
Regeneron Study Site
Hackensack, New Jersey, 07601
Regeneron Study Site
Livingston, New Jersey, 07039
Regeneron Study Site
Los Angeles, California, 90095
Regeneron Study Site 1
Manhasset, New York, 11030
Regeneron Study Site 2
Manhasset, New York, 11030
Regeneron Study Site
Marietta, Georgia, 30060
Regeneron Study Site
Morristown, New Jersey, 07960
Regeneron Study Site
Murray, Utah, 84107
Regeneron Study Site
Neptune City, New Jersey, 07753
Regeneron Study Site
New Haven, Connecticut, 06520
Regeneron Study Site
New Orleans, Louisiana, 70112
Regeneron Study Site
New York, New York, 10003
Regeneron Study Site
New York, New York, 10016
Regeneron Study Site 1
New York, New York, 10025
Regeneron Study Site 2
New York, New York, 10025
Regeneron Study Site
New York, New York, 10029
Regeneron Study Site
New York, New York, 10032
Regeneron Study Site
New York, New York, 10037
Regeneron Study Site
New York, New York, 10065
Regeneron Study Site
New York, New York, 10075
Regeneron Study Site
Newark, New Jersey, 07112
Regeneron Study Site
Orlando, Florida, 32803
Regeneron Study Site
Philadelphia, Pennsylvania, 19140
Regeneron Study Site
Portland, Oregon, 97213
Regeneron Study Site
Portland, Oregon, 97239
Regeneron Study Site
Renton, Washington, 98055
Regeneron Study Site
Richmond, Virginia, 23298
Regeneron Study Site
Rochester, Minnesota, 55905
Regeneron Study Site
Sacramento, California, 95817
Regeneron Study Site
Santa Monica, California, 90404
Regeneron Study Site
Scranton, Pennsylvania, 18510
Regeneron Study Site
Stony Brook, New York, 11794
Regeneron Study Site
Tampa, Florida, 33606
Regeneron Study Site
Teaneck, New Jersey, 07666
Regeneron Study Site
The Bronx, New York, 10451
Regeneron Study Site 1
The Bronx, New York, 10461
Regeneron Study Site 2
The Bronx, New York, 10461
Regeneron Study Site
The Bronx, New York, 10467
Regeneron Study Site
Tulsa, Oklahoma, 74104
Regeneron Study Site
Valhalla, New York, 10595
Regeneron Study Site
Washington D.C., District of Columbia, 20010
Regeneron Study Site
Wilkes-Barre, Pennsylvania, 18711
About this study
Official title: An Adaptive Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study Assessing Efficacy and Safety of Sarilumab for 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.
Read the detailed description
Phase 2 and Phase 3 Cohort 1 completed. Cohorts 2 and 3 terminated early based on Phase 3 Cohort 1 results.
- Conditions
- COVID-19
- Being tested
- Sarilumab, Placebo
- Keywords
- COVID-19, SARS-COV-2, coronavirus, IL-6, sarilumab, acute respiratory distress syndrome, treatment
- Medical subject headings
- COVID-19, Coronavirus Infections, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SarilumabDrug
Also called Kevzara®, REGN88, SAR153191
Single or multiple intravenous (IV) doses of sarilumab. Additional doses may be administered if the patient meets protocol defined criteria.
PlaceboDrug
Single or multiple intravenous (IV) doses of placebo to match sarilumab administration
| Study group | Role | What they receive |
|---|---|---|
| Sarilumab 200mg IV (P2) | Experimental | Phase 2 Receives: Drug: Sarilumab; Drug: Placebo |
| Sarilumab 200mg IV (P3:C1) | Experimental | Phase 3: Cohort 1 Receives: Drug: Sarilumab; Drug: Placebo |
| Sarilumab 400mg IV (P2) | Experimental | Phase 2 Receives: Drug: Sarilumab; Drug: Placebo |
| Sarilumab 400mg IV (P3:C1) | Experimental | Phase 3: Cohort 1 Receives: Drug: Sarilumab; Drug: Placebo |
| Sarilumab 800mg IV (P3:C2) | Experimental | Phase 3: Cohort 2 Receives: Drug: Sarilumab; Drug: Placebo |
| Sarilumab 800mg IV (P3: C3) | Experimental | Phase 3: Cohort 3 Receives: Drug: Sarilumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in CRP Levels at Day 4 in Participants With Serum IL-6 Level Greater Than the ULN (Phase 2)
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.
Measured: Baseline and Day 4
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)
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
Measured: Day 22
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)
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
Measured: Day 22
Secondary outcomes (71)
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 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
Measured: Up to Day 29
Time to Improvement (2 Points) in Clinical Status Assessment in Severe or Critical Patients With All Serum IL-6 Levels (Phase 2)
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
Measured: 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 at Baseline (Phase 2)
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).
Measured: Up to Day 29
Time to Resolution of Fever for at Least 48 Hours Without Antipyretics by Clinical Severity (Phase 2)
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.
Measured: Up to day 29
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)
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.
Measured: Up to Day 29
Time to Improvement in Oxygenation for at Least 48 Hours (Phase 2)
Improvement in oxygenation defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2
Measured: Up to day 29
Time to Improvement in Oxygenation for at Least 48 Hours by Baseline IL-6 Levels (Phase 2)
Time to Improvement defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2
Measured: Up to day 29
Time to Resolution of Fever and Improvement in Oxygenation for at Least 48 Hours (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
Measured: Up to day 29
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
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
Measured: Days 1, 3, 5, 8, 11, 15 and 29
Time to Discharge or to a National Early Warning Score 2 (NEWS2) of ≤2 and Maintained for 24 Hours (Phase 2)
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).
Measured: Up to day 29
Change From Baseline in NEWS2 Scoring System (Phase 2)
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).
Measured: Days 3, 5, 8, 11, 15 and 29
Number of Days With Fever (Phase 2)
Defined as ≥38°C (oral), ≥38.4°C (rectal or tympanic) or ≥37.6°C (temporal or axillary)
Measured: Up to Day 29
Percentage of Participants Alive, Off Oxygen (Phase 2)
Measured: At Day 29
Number of Days of Resting Respiratory Rate >24 Breaths/Min (Phase 2)
Measured: Up to day 29
Number of Days With Hypoxemia (Phase 2)
Measured: Up to day 29
Number of Days of Supplemental Oxygen Use (Phase 2)
Measured: Up to day 29
Time to Saturation ≥94% on Room Air (Phase 2)
Measured: Up to day 29
Number of Ventilator Free Days (Phase 2)
Summary of Ventilator-free days during study in Participants using Invasive Mechanical Ventilation at Baseline
Measured: Up to Day 22
Number of Participants Who Initiated Mechanical Ventilation After Baseline (Phase 2)
Measured: Up to Day 29
Number of Days in an Intensive Care Unit (ICU) in Participants Who Were Not in ICU at Baseline (Phase 2)
Measured: Up to Day 29
Number of Days of Hospitalization Among Survivors (Phase 2)
Measured: Up to day 29
Number of Deaths Due to Any Cause
Number of deaths due to any cause (All-Cause Mortality)
Measured: Up to day 60
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)
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
Measured: Day 22
Percentage of Participants Who Recover (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
Percentage of Participants Who Recover (Discharged, or Alive without Supplemental Oxygen Use or at Pre-COVID Oxygen Use) at Day 22
Measured: Day 22
Percentage of Participants Who Recover (Phase 3 Cohort 1: Critical ITT)
Percentage of Participants Who Recover (Discharged, or Alive without Supplemental Oxygen Use or at Pre-COVID Oxygen Use) at Day 22
Measured: Day 22
Percentage of Participants Who Die (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
Percentage of Participants who die through Day 29 and Day 60
Measured: Up to Day 29 and Day 60
Percentage of Participants Who Die (Phase 3 Cohort 1: Critical ITT)
Percentage of Participants who die through Day 29 and Day 60
Measured: Up to Day 29 and Day 60
Percentage of Participants Alive Not Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
Percentage of participants alive not receiving mechanical ventilation or ECMO at Day 22 (Phase 3 Cohort 1)
Measured: 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 (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
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
Measured: At Day 22
Percentage of Participants Alive Not Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical ITT)
Percentage of participants alive not receiving mechanical ventilation or ECMO at Day 22 (Phase 3 Cohort 1)
Measured: 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 (Phase 3 Cohort 1: Critical ITT)
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
Measured: At Day 22
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)
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
Measured: Up to day 29
Time to at Least 1-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical ITT)
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
Measured: Up to day 29
Time to at Least 1-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 2)
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
Measured: Up to day 29
Time to at Least 2-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1)
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
Measured: Up to day 29
Time to at Least 2-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical ITT)
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
Measured: Up to day 29
Percentage of Participants Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
Measured: Day 22
Percentage of Participants Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical ITT)
Measured: Day 22
Percentage of Patients Discharged and Alive (Phase 3 Cohort 1)
Percentage of Patients Discharged and Alive at Day 22
Measured: At Day 22
Percentage of Participants Discharged and Alive at Day 22 (Phase 3 Cohort 1: Critical ITT)
Percentage of Participants Discharged and Alive at Day 22
Measured: At Day 22
Time to Recovery (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
Phase 3 Cohort 1 Time to Recovery (Discharged, or Alive without Supplemental Oxygen Use or at Pre-COVID Oxygen Use)
Measured: Up to day 29
Time to Recovery (Phase 3 Cohort 1: Critical ITT)
Phase 3 Cohort 1 Time to Recovery (Discharged, or Alive without Supplemental Oxygen Use or at Pre-COVID Oxygen Use)
Measured: Up to day 29
Time to Recovery (Phase 3 Cohort 2)
Time to Recovery (Discharged, or Alive without Supplemental Oxygen Use or at Pre-COVID Oxygen Use)
Measured: Up to day 29
Time to Death (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
Phase 3 Cohort 1 Time to Death (All-Cause Mortality)
Measured: Up to day 60
Time to Death (Phase 3 Cohort 1: Critical ITT)
Time to Death (All-Cause Mortality)
Measured: Up to day 60
Time to Death (Phase 3 Cohort 2)
Time to Death (All-Cause Mortality)
Measured: Up to day 60
Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
Number of Ventilator-Free days up to Day 29 (Phase 3 Cohort 1)
Measured: Days 8, 15, 22 and 29
Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical ITT)
Number of Ventilator-Free days up to Day 29 (Phase 3 Cohort 1)
Measured: Days 8, 15, 22 and 29
Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1)
Number of days of hospitalization among survivors (Phase 3 Cohort 1)
Measured: Days 8, 15, 22 and 29
Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1: Critical ITT)
Number of days of hospitalization among survivors (Phase 3 Cohort 1: Critical ITT population)
Measured: Days 8, 15, 22 and 29
Number of Participants With Any Serious Adverse Event
Measured: Up to day 60
Number of Participants With Grade 4 Neutropenia (ANC <500/mm3)
Grade 4 Neutropenia defined as Absolute Neutrophil Count (ANC) of less than 500 per cubic millimeter(mm3)
Measured: Up to day 60
Number of Participants With Severe or Life-threatening Bacterial, Invasive Fungal, or Opportunistic Infection
Measured: Up to day 60
Number of Participants With Grade 4 Neutropenia and Concurrent Invasive Infection
Measured: Up to day 60
Number of Participants With Grade >=2 Infusion Related Reactions
Measured: Up to day 60
Number of Participants With Grade >=2 Hypersensitivity Reactions
Measured: Up to day 60
Number of Participants With Gastrointestinal Perforation
Measured: Up to day 60
Mean Observed Leukocyte Values Across Study Days (Phase 2)
Measured: Days 1, 4, 15 and 29
Mean Observed Leukocyte Values Across Study Days (Phase 3)
Measured: Days 1, 4, 15 and 29
Mean Observed Hemoglobin Values Across Study Days (Phase 2)
Measured: Days 1, 4, 15 and 29
Mean Observed Hemoglobin Values Across Study Days (Phase 3)
Measured: Days 1, 4, 15 and 29
Mean Observed Platelet Count Across Study Days (Phase 2)
Measured: Days 1, 4, 15 and 29
Mean Observed Platelet Count Across Study Days (Phase 3)
Measured: Days 1, 4, 15 and 29
Mean Observed Total Bilirubin Values Across Study Days (Phase 2)
Measured: Days 1, 4, 15 and 29
Mean Observed Total Bilirubin Across Study Days (Phase 3)
Measured: Days 1, 4, 15 and 29
Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 2)
Measured: Days 1, 4, 15 and 29
Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3)
Measured: Days 1, 4, 15 and 29
Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 2)
Measured: Days 1, 4, 15 and 29
Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3)
Measured: Days 1, 4, 15 and 29
Mean Observed Creatinine Values Across Study Days (Phase 2)
Measured: Days 1, 4, 15 and 29
Mean Observed Creatinine Values Across Study Days (Phase 3)
Measured: Days 1, 4, 15 and 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start18 Mar 2020
- Primary completion24 Jul 2020
- Study completion2 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,912 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315298
- Sponsor's protocol ID
- 6R88-COV-2040
- Status last verified
- Sep 2021
- First submitted
- 15 Mar 2020
- Last updated
- 23 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie publicly available results will be considered for sharing
Publications
Devalaraja-Narashimha K, Ehmann PJ, Huang C, Ruan Q, Wipperman MF, Kaplan T, Liu C, Afolayan S, Glass DJ, Mellis S, Yancopoulos GD, Hamilton JD, MacDonnell S, Hamon SC, Boyapati A, Morton L. Association of complement pathways with COVID-19 severity and outcomes. Microbes Infect. 2023 May;25(4):105081. doi: 10.1016/j.micinf.2022.105081. Epub 2022 Dec 7.
PubMed 36494054Sivapalasingam S, Lederer DJ, Bhore R, Hajizadeh N, Criner G, Hosain R, Mahmood A, Giannelou A, Somersan-Karakaya S, O'Brien MP, Boyapati A, Parrino J, Musser BJ, Labriola-Tompkins E, Ramesh D, Purcell LA, Gulabani D, Kampman W, Waldron A, Ng Gong M, Saggar S, Sperber SJ, Menon V, Stein DK, Sobieszczyk ME, Park W, Aberg JA, Brown SM, Kosmicki JA, Horowitz JE, Ferreira MA, Baras A, Kowal B, Thomas DiCioccio A, Akinlade B, Nivens MC, Braunstein N, Herman GA, Yancopoulos GD, Weinreich DM. Efficacy and Safety of Sarilumab in Hospitalized Patients With Coronavirus Disease 2019: A Randomized Clinical Trial. Clin Infect Dis. 2022 Aug 24;75(1):e380-e388. doi: 10.1093/cid/ciac153.
PubMed 35219277Boyapati A, Wipperman MF, Ehmann PJ, Hamon S, Lederer DJ, Waldron A, Flanagan JJ, Karayusuf E, Bhore R, Nivens MC, Hamilton JD, Sumner G, Sivapalasingam S. Baseline Severe Acute Respiratory Syndrome Viral Load Is Associated With Coronavirus Disease 2019 Severity and Clinical Outcomes: Post Hoc Analyses of a Phase 2/3 Trial. J Infect Dis. 2021 Dec 1;224(11):1830-1838. doi: 10.1093/infdis/jiab445.
PubMed 34496013
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04315298
- Acronym / sponsor ID
- 6R88-COV-2040
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-COV-2, coronavirus, IL-6, sarilumab, acute respiratory distress syndrome, treatment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,912 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- 18 Mar 2020 (actual)
- Primary completion
- 24 Jul 2020 (actual)
- Study completion
- 2 Sep 2020 (actual)
- First posted
- 19 Mar 2020 (actual)
- Results
- Posted 23 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Phase 2 and Phase 3 Cohort 1 completed. Cohorts 2 and 3 terminated early based on Phase 3 Cohort 1 results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sarilumab 200mg IV (P2) | Experimental | Drug: Sarilumab, Drug: PlaceboPhase 2 |
| Sarilumab 200mg IV (P3:C1) | Experimental | Drug: Sarilumab, Drug: PlaceboPhase 3: Cohort 1 |
| Sarilumab 400mg IV (P2) | Experimental | Drug: Sarilumab, Drug: PlaceboPhase 2 |
| Sarilumab 400mg IV (P3:C1) | Experimental | Drug: Sarilumab, Drug: PlaceboPhase 3: Cohort 1 |
| Sarilumab 800mg IV (P3:C2) | Experimental | Drug: Sarilumab, Drug: PlaceboPhase 3: Cohort 2 |
| Sarilumab 800mg IV (P3: C3) | Experimental | Drug: Sarilumab, Drug: PlaceboPhase 3: Cohort 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- Severe disease OR
- Critical disease OR
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SarilumabAlso: Kevzara®, REGN88, SAR153191Single or multiple intravenous (IV) doses of sarilumab. Additional doses may be administered if the patient meets protocol defined criteria. | Drug | Sarilumab 200mg IV (P2), Sarilumab 200mg IV (P3:C1), Sarilumab 400mg IV (P2), Sarilumab 400mg IV (P3:C1), Sarilumab 800mg IV (P3: C3), Sarilumab 800mg IV (P3:C2) |
| PlaceboSingle or multiple intravenous (IV) doses of placebo to match sarilumab administration | Drug | Sarilumab 200mg IV (P2), Sarilumab 200mg IV (P3:C1), Sarilumab 400mg IV (P2), Sarilumab 400mg IV (P3:C1), Sarilumab 800mg IV (P3: C3), Sarilumab 800mg IV (P3:C2) |
Primary outcome
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.
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: 1. 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
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: 1. 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
71 secondary outcomes
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 in Severe or Critical Patients With All Serum IL-6 Levels (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 at Baseline (Phase 2)
Time frame: Up to Day 29
Time to Resolution of Fever for at Least 48 Hours Without Antipyretics by Clinical Severity (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, by Baseline IL-6 Levels (Phase 2)
Time frame: Up to Day 29
Time to Improvement in Oxygenation for at Least 48 Hours (Phase 2)
Time frame: Up to day 29
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 Resolution of Fever and Improvement in Oxygenation for at Least 48 Hours (Phase 2)
Time frame: Up to day 29
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
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
Change From Baseline in NEWS2 Scoring System (Phase 2)
Time frame: Days 3, 5, 8, 11, 15 and 29
Number of Days With Fever (Phase 2)
Time frame: Up to Day 29
Percentage of Participants Alive, Off Oxygen (Phase 2)
Time frame: At Day 29
Number of Days of Resting Respiratory Rate >24 Breaths/Min (Phase 2)
Time frame: Up to day 29
Number of Days With Hypoxemia (Phase 2)
Time frame: Up to day 29
Number of Days of Supplemental Oxygen Use (Phase 2)
Time frame: Up to day 29
Time to Saturation ≥94% on Room Air (Phase 2)
Time frame: Up to day 29
Number of Ventilator Free Days (Phase 2)
Time frame: Up to Day 22
Number of Participants Who Initiated Mechanical Ventilation After Baseline (Phase 2)
Time frame: Up to Day 29
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
Number of Days of Hospitalization Among Survivors (Phase 2)
Time frame: Up to day 29
Number of Deaths Due to Any Cause
Time frame: Up to day 60
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
Percentage of Participants Who Recover (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
Time frame: Day 22
Percentage of Participants Who Recover (Phase 3 Cohort 1: Critical ITT)
Time frame: Day 22
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 (Phase 3 Cohort 1: Critical ITT)
Time frame: Up to Day 29 and Day 60
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 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 Alive Not Receiving Mechanical Ventilation or ECMO at Day 22 (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 (Phase 3 Cohort 1: Critical ITT)
Time frame: At Day 22
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
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
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
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
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
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
Percentage of Participants Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical ITT)
Time frame: Day 22
Percentage of Patients Discharged and Alive (Phase 3 Cohort 1)
Time frame: At Day 22
Percentage of Participants Discharged and Alive at Day 22 (Phase 3 Cohort 1: Critical ITT)
Time frame: At Day 22
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36494054Devalaraja-Narashimha K, Ehmann PJ, Huang C, Ruan Q, Wipperman MF, Kaplan T, Liu C, Afolayan S, Glass DJ, Mellis S, Yancopoulos GD, Hamilton JD, MacDonnell S, Hamon SC, Boyapati A, Morton L. Association of complement pathways with COVID-19 severity and outcomes. Microbes Infect. 2023 May;25(4):105081. doi: 10.1016/j.micinf.2022.105081. Epub 2022 Dec 7.
- Derived from this study: PubMed 35219277Sivapalasingam S, Lederer DJ, Bhore R, Hajizadeh N, Criner G, Hosain R, Mahmood A, Giannelou A, Somersan-Karakaya S, O'Brien MP, Boyapati A, Parrino J, Musser BJ, Labriola-Tompkins E, Ramesh D, Purcell LA, Gulabani D, Kampman W, Waldron A, Ng Gong M, Saggar S, Sperber SJ, Menon V, Stein DK, Sobieszczyk ME, Park W, Aberg JA, Brown SM, Kosmicki JA, Horowitz JE, Ferreira MA, Baras A, Kowal B, Thomas DiCioccio A, Akinlade B, Nivens MC, Braunstein N, Herman GA, Yancopoulos GD, Weinreich DM. Efficacy and Safety of Sarilumab in Hospitalized Patients With Coronavirus Disease 2019: A Randomized Clinical Trial. Clin Infect Dis. 2022 Aug 24;75(1):e380-e388. doi: 10.1093/cid/ciac153.
- Derived from this study: PubMed 34496013Boyapati A, Wipperman MF, Ehmann PJ, Hamon S, Lederer DJ, Waldron A, Flanagan JJ, Karayusuf E, Bhore R, Nivens MC, Hamilton JD, Sumner G, Sivapalasingam S. Baseline Severe Acute Respiratory Syndrome Viral Load Is Associated With Coronavirus Disease 2019 Severity and Clinical Outcomes: Post Hoc Analyses of a Phase 2/3 Trial. J Infect Dis. 2021 Dec 1;224(11):1830-1838. doi: 10.1093/infdis/jiab445.
- Individual participant dataSharing planned: Yes. All IPD that underlie publicly available results will be considered for sharing
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
62 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sarilumab in people with COVID-19, run by Regeneron Pharmaceuticals at 62 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04315298, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.