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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.

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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.

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

FieldValue
Enrollment Target 212 participants
Start Date 2020-04-24
Est. Completion 2021-06-24
Phase Phase 2

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.