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NCT04380961 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of Sirukumab in Confirmed Severe or Critical Confirmed Coronavirus Disease (COVID)-19
A Phase 2 study of Critical Confirmed Coronavirus Disease (COVID)-19, sponsored by Janssen Pharmaceutica N.V., Belgium.
- Completed
- Registry status
- Phase 2
- Development phase
- 212
- Enrollment target
- 16
- Study locations
NCT04380961: Completed Phase 2 study of Critical Confirmed Coronavirus Disease (COVID)-19, sponsored by Janssen Pharmaceutica N.V., Belgium.
NCT04380961 is a Phase 2 study of Critical Confirmed Coronavirus Disease (COVID)-19 that has completed, run by Janssen Pharmaceutica N.V., Belgium. The registered enrollment target is 212 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% higher). The trial reports 16 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04380961, a Phase 2 study of Critical Confirmed Coronavirus Disease (COVID)-19, has completed, sponsored by Janssen Pharmaceutica N.V., Belgium.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 212 participants
- Enrollment target
- 16
- Study locations
Study Summary
The purpose of this study is to evaluate the clinical response of sirukumab (administered as a single intravenous dose) plus standard of care (SOC) compared to placebo plus SOC in COVID-19.
Primary Outcome
Time to sustained improvement is defined as an improvement of at least 2 categories relative to baseline on the 6-point ordinal clinical recovery scale sustained until Day 28. The 6-point ordinal CRS provides 6 mutually exclusive conditions ordered from best (score 1) to worst (score 6) corresponding to below categories, reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are: not hospitalized, including participants on low level of oxyg
Conditions Studied
Interventions
- DRUG Placebo
- OTHER Standard of Care (SOC)
- DRUG Sirukumab
Study Locations (16)
Illinois
- Great Lakes Clinical Trials - Chicago
- Loyola University Medical Center - Maywood
- University of Illinois College of Medicine at Peoria - Peoria
California
- MemorialCare Research Miller Children's and Women's Hospital Long Beach - Long Beach
- Hoag Memorial Hospital - Newport Beach
Michigan
- Henry Ford Hospital - Detroit
- Beaumont Health Systems - Royal Oak
Texas
- Baylor Scott & White Research Institute - Dallas
- Baylor All Saints Medical Center at Fort Worth - Fort Worth
Florida
- Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center - Fort Lauderdale
Louisiana
- Louisiana State University Health Sciences Center - New Orleans
Missouri
- Washington University School of Medicine - St Louis
Montana
- Mercury Street Medical Group, PLLC - Butte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 212 participants |
| Start Date | 2020-04-24 |
| Est. Completion | 2021-06-24 |
| Phase | Phase 2 |
What the finished NCT04380961 record still lists
NCT04380961 is an interventional study that assigns participants to a tested intervention. The registered 212 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% higher).
The record links to 1 condition, with Critical Confirmed Coronavirus Disease (COVID)-19 appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04380961 lists 16 locations in 11 states (Illinois, California, Michigan).
Frequently Asked Questions
What is clinical trial NCT04380961 about?
NCT04380961 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Sirukumab in Confirmed Severe or Critical Confirmed Coronavirus Disease (COVID)-19". The purpose of this study is to evaluate the clinical response of sirukumab (administered as a single intravenous dose) plus standard of care (SOC) compared to placebo plus SOC in COVID-19.
What is the current status of trial NCT04380961?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 212 participants. The study started on 2020-04-24. Estimated completion is 2021-06-24.
What conditions does trial NCT04380961 study?
This clinical trial studies the following conditions: Critical Confirmed Coronavirus Disease (COVID)-19.
What interventions are being tested in trial NCT04380961?
The interventions under investigation include: Placebo (DRUG), Standard of Care (SOC) (OTHER), Sirukumab (DRUG).
Who is sponsoring clinical trial NCT04380961?
This trial is sponsored by Janssen Pharmaceutica N.V., Belgium, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04380961 being conducted?
This trial has 16 study locations across California, Florida, Illinois, Louisiana, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04380961's enrollment target sits among peer trials
212 290th of 2000 higher than 1,711 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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