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NCT04351243 · ClinicalTrials.gov registry record · Phase 2

A Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE)

A Phase 2 study of COVID-19, sponsored by Kinevant Sciences.

Completed
Registry status
Phase 2
Development phase
227
Enrollment target
20
Study locations

NCT04351243 is a Phase 2 study of COVID-19 that has completed, run by Kinevant Sciences. The registered enrollment target is 227 participants, below the 55,213-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT04351243, a Phase 2 study of COVID-19, has completed, sponsored by Kinevant Sciences.

COMPLETED
Registry status
Phase 2
Development phase
227 participants
Enrollment target
20
Study locations

Study Summary

Study KIN-1901-2001 is a multi-center, adaptive, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of gimsilumab in subjects with lung injury or acute respiratory distress syndrome (ARDS) secondary to COVID-19.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Gimsilumab

Study Locations (20)

Arizona

  • Banner University Medical Center - Phoenix
  • HonorHealth John C. Lincoln Medical Center - Phoenix
  • HonorHealth Scottsdale Osborn Medical Center - Scottsdale
  • HonorHealth - Scottsdale
  • HonorHealth Scottsdale Shea Medical Center - Scottsdale
  • Banner University Medical Center - Tucson

New York

  • Jamaica Hospital Medical Center - Jamaica
  • Mount Sinai Beth Israel - New York
  • Mount Sinai West - New York
  • Mount Sinai Morningside - New York
  • Icahn School of Medicine at Mount Sinai - New York

Florida

  • University of Florida - Gainesville
  • Miami Cancer institute - Miami

Georgia

  • Piedmont Healthcare - Atlanta
  • Emory University School of Medicine - Atlanta

California

  • UCLA Ronald Reagan Medical Center - Los Angeles

Illinois

  • NorthShore University HealthSystem - Evanston

Louisiana

  • East Jefferson General Hospital - Metairie

Massachusetts

  • Brigham and Women's Hospital - Boston

Trial Details

FieldValue
Enrollment Target 227 participants
Start Date 2020-04-15
Est. Completion 2021-04-01
Phase Phase 2

Sponsor

Kinevant Sciences

3 total trials

What the Registry Record Tells You About NCT04351243

The ClinicalTrials.gov registry entry for NCT04351243 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 227 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55,213-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The listed sponsor is Kinevant Sciences, which has 3 total studies on file at ClinicalTrials.gov.

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.

NCT04351243 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Arizona, New York, Florida.

Frequently Asked Questions

What is clinical trial NCT04351243 about?

NCT04351243 is a clinical study titled "A Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE)". Study KIN-1901-2001 is a multi-center, adaptive, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of gimsilumab in subjects with lung injury or acute respiratory distress syndrome (ARDS) secondary to COVID-19.

What is the current status of trial NCT04351243?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 227 participants. The study started on 2020-04-15. Estimated completion is 2021-04-01.

What conditions does trial NCT04351243 study?

This clinical trial studies the following conditions: COVID-19.

What interventions are being tested in trial NCT04351243?

The interventions under investigation include: Placebo (DRUG), Gimsilumab (DRUG).

Who is sponsoring clinical trial NCT04351243?

This trial is sponsored by Kinevant Sciences, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04351243 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.