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NCT04315298 · ClinicalTrials.gov registry record · Phase 2
Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19
A Phase 2 study of COVID-19, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,912
- Enrollment target
- 20
- Study locations
NCT04315298: Completed Phase 2 study of COVID-19, sponsored by Regeneron Pharmaceuticals.
NCT04315298 is a Phase 2 study of COVID-19 that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 1,912 participants, below the 38,459-participant average among 298 other COVID-19 trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04315298, a Phase 2 study of COVID-19, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,912 participants
- Enrollment target
- 20
- Study locations
Study Summary
Phase 2: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with COVID-19 regardless of disease severity strata. Phase 3 Cohort 1: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with critical COVID-19 receiving mechanical ventilation at baseline. Phase 3 Cohort 2: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with COVID-19 receiving mechanical ventilation at baseline.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Sarilumab
Study Locations (20)
California
- Regeneron Study Site - Los Angeles
- Regeneron Study Site - Sacramento
- Regeneron Study Site - Santa Monica
Florida
- Regeneron Study Site - Gainesville
- Regeneron Study Site - Orlando
- Regeneron Study Site - Tampa
Georgia
- Regeneron Study Site - Atlanta
- Regeneron Study Site - Decatur
- Regeneron Study Site - Marietta
Massachusetts
- Regeneron Study Site - Boston
- Regeneron Study Site - Boston
- Regeneron Study Site - Boston
Colorado
- Regeneron Study Site - Aurora
- Regeneron Study Site - Denver
Illinois
- Regeneron Study Site - Chicago
- Regeneron Study Site - Chicago
Connecticut
- Regeneron Study Site - New Haven
District of Columbia
- Regeneron Study Site - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,912 participants |
| Start Date | 2020-03-18 |
| Est. Completion | 2020-09-02 |
| Phase | Phase 2 |
What the finished NCT04315298 record still lists
NCT04315298 is an interventional study that assigns participants to a tested intervention. Its 1,912 participants enrollment target places it among the larger protocols in the corpus, below the 38,459-participant average among 298 other COVID-19 trials with a reported enrollment target (95% lower).
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04315298 names 20 study sites across 10 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT04315298 about?
NCT04315298 is a clinical study titled "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 o...
What is the current status of trial NCT04315298?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,912 participants. The study started on 2020-03-18. Estimated completion is 2020-09-02.
What conditions does trial NCT04315298 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT04315298?
The interventions under investigation include: Placebo (DRUG), Sarilumab (DRUG).
Who is sponsoring clinical trial NCT04315298?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04315298 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for COVID-19
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04315298's enrollment target sits among peer trials
1,912 47th of 298 higher than 252 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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