Sarilumab for Patients With Moderate COVID-19 Disease
Public ClinicalTrials.gov record NCT04359901. 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
Sarilumab for Patients With Moderate COVID-19 Disease: A Randomized Controlled Trial With a Play-The-Winner Design
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Objectives: To determine whether blockade of IL-6R is beneficial in patients with COVID-19 infection of moderate severity. Research Design: Randomized, controlled trial. Two-arm trial comparing standard care alone to standard care with addition of sarilumab (anti-IL6R). The trial will use a randomized play-the-winner design, in which randomization becomes weighted toward the arm that was more effective in previous subjects in the trial. Methodology Hospitalized patients meeting clinical criteria for moderate disease and testing positive for coronavirus infection. Interventions: sarilumab, 400 mg subcutaneous injection. Standard care is not pre-specified, may vary among patients, and may include agents with anti-viral activity, such as remdesivir or hydroxychloroquine, among others. Up to 120 patients, primary outcome intubation or death within 14 days. All data will be extracted remotely from the electronic health record (EHR). Clinical Implications: The study has potential to establish IL-6R blockade, delivered subcutaneously, as standard of care in reducing progression to critical illness in patients with moderate COVID-19 disease.
Study identification
- NCT ID
- NCT04359901
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 50 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
- Apr 9, 2020
- Primary completion
- Aug 1, 2021
- Completion
- Aug 1, 2021
- Last update posted
- Dec 5, 2023
2020 – 2021
United States locations
- U.S. sites
- 5
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| VA Connecticut Healthcare System | West Haven | Connecticut | 06516 | — |
| VA Maine Healthcare System | Augusta | Maine | 04330 | — |
| VA Boston Healthcare System | Boston | Massachusetts | 02132 | — |
| Providence VA Medical Center | Providence | Rhode Island | 02908 | — |
| VA Medical Center - White River Junction | White River Junction | Vermont | 05009 | — |
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 NCT04359901, 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 Dec 5, 2023 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04359901 live on ClinicalTrials.gov.