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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 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. The trial reports 16 study locations across 11 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04380961
The ClinicalTrials.gov registry entry for NCT04380961 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 212 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Pharmaceutica N.V., Belgium, which has 6 total studies on file at ClinicalTrials.gov.
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 reports 16 study locations spanning 11 distinct geographic areas - top geographies include 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.
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