Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19
Public ClinicalTrials.gov record NCT04315298. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04315298
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 1,912 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 17, 2020
- Primary completion
- Jul 23, 2020
- Completion
- Sep 1, 2020
- Last update posted
- Sep 22, 2021
2020
United States locations
- U.S. sites
- 62
- U.S. states
- 20
- U.S. cities
- 45
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Regeneron Study Site | Los Angeles | California | 90095 | — |
| Regeneron Study Site | Sacramento | California | 95817 | — |
| Regeneron Study Site | Santa Monica | California | 90404 | — |
| Regeneron Study Site | Aurora | Colorado | 80045 | — |
| Regeneron Study Site | Denver | Colorado | 80206 | — |
| Regeneron Study Site | New Haven | Connecticut | 06520 | — |
| Regeneron Study Site | Washington D.C. | District of Columbia | 20010 | — |
| Regeneron Study Site | Gainesville | Florida | 32610 | — |
| Regeneron Study Site | Orlando | Florida | 32803 | — |
| Regeneron Study Site | Tampa | Florida | 33606 | — |
| Regeneron Study Site | Atlanta | Georgia | 30322 | — |
| Regeneron Study Site | Decatur | Georgia | 30033 | — |
| Regeneron Study Site | Marietta | Georgia | 30060 | — |
| Regeneron Study Site | Chicago | Illinois | 60611 | — |
| Regeneron Study Site | Chicago | Illinois | 60612 | — |
| Regeneron Study Site | New Orleans | Louisiana | 70112 | — |
| Regeneron Study Site | Boston | Massachusetts | 02111 | — |
| Regeneron Study Site | Boston | Massachusetts | 02114 | — |
| Regeneron Study Site | Boston | Massachusetts | 02215 | — |
| Regeneron Study Site | Ann Arbor | Michigan | 48109 | — |
| Regeneron Study Site | Rochester | Minnesota | 55905 | — |
| Regeneron Study Site | Edison | New Jersey | 08820 | — |
| Regeneron Study Site | Hackensack | New Jersey | 07601 | — |
| Regeneron Study Site | Livingston | New Jersey | 07039 | — |
| Regeneron Study Site | Morristown | New Jersey | 07960 | — |
| Regeneron Study Site | Neptune City | New Jersey | 07753 | — |
| Regeneron Study Site | Newark | New Jersey | 07112 | — |
| Regeneron Study Site | Teaneck | New Jersey | 07666 | — |
| Regeneron Study Site | Brooklyn | New York | 11219 | — |
| Regeneron Study Site | Buffalo | New York | 14263 | — |
| Regeneron Study Site | Elmhurst | New York | 11373 | — |
| Regeneron Study Site 1 | Manhasset | New York | 11030 | — |
| Regeneron Study Site 2 | Manhasset | New York | 11030 | — |
| 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 | Stony Brook | New York | 11794 | — |
| 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 | Valhalla | New York | 10595 | — |
| Regeneron Study Site | Tulsa | Oklahoma | 74104 | — |
| Regeneron Study Site | Portland | Oregon | 97213 | — |
| Regeneron Study Site | Portland | Oregon | 97239 | — |
| Regeneron Study Site | Danville | Pennsylvania | 17822 | — |
| Regeneron Study Site | Philadelphia | Pennsylvania | 19140 | — |
| Regeneron Study Site | Scranton | Pennsylvania | 18510 | — |
| Regeneron Study Site | Wilkes-Barre | Pennsylvania | 18711 | — |
| Regeneron Study Site | Dallas | Texas | 75246 | — |
| Regeneron Study Site | Dallas | Texas | 75390 | — |
| Regeneron Study Site | Murray | Utah | 84107 | — |
| Regeneron Study Site | Falls Church | Virginia | 22042 | — |
| Regeneron Study Site | Richmond | Virginia | 23298 | — |
| Regeneron Study Site | Everett | Washington | 98201 | — |
| Regeneron Study Site | Renton | Washington | 98055 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04315298, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 22, 2021 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04315298 live on ClinicalTrials.gov.