Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)

NCT04377620 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: INCB 18424-369
• Study Type: interventional
• Target: 211
• Locations: 2 countries
• Sites: 36

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the treatment of participants with COVID-19-associated Acute Respiratory Distress Syndrome (ARDS) who require mechanical ventilation.

Conditions

COVID-19

Keywords

Cytokine storm; COVID-19; ARDS; SARS-CoV-2; ruxolitinib; pneumonia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Have Died Due to Any Cause

  To evaluate the 28-day mortality rate of ruxolitinib 5 mg BID + SoC therapy and ruxolitinib 15 mg BID + SoC compared with placebo + SoC therapy, in participants with COVID-19-associated ARDS who require mechanical ventilation.

  Study start to Day 29

Secondary Outcomes (12)

• Number of Ventilator Free Days

  Study start to Day 29

• Number of ICU Free Days

  Study start to Day 29

• Oxygen Free Days

  Study start to Day 29

• Vasopressor Free Days

  Study start to Day 29

• Hospital Free Days

  Study start to Day 29

Study Arms (3)

Placebo + Standard of Care (SoC)

PLACEBO COMPARATOR

Matching Placebo will be administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.

Drug: Placebo

Ruxolitinib 5mg + Standard of Care (SoC)

EXPERIMENTAL

Ruxolitinib 5mg will be administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.

Drug: Ruxolitinib

Ruxolitininb 15mg + Standard of Care (SoC)

EXPERIMENTAL

Ruxolitinib 15mg will be administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.

Drug: Ruxolitinib

Interventions

Placebo DRUG

Placebo administered BID approximately 12 hours apart

Placebo + Standard of Care (SoC)

Ruxolitinib DRUG

Ruxolitinb administered BID approximately 12 hours apart

Also known as: INCB018424, Oral Jak Inhibitor

Ruxolitinib 5mg + Standard of Care (SoC); Ruxolitininb 15mg + Standard of Care (SoC)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant or guardian health proxy must provide informed consent before any study assessment is performed.
• Male or female participants aged ≥ 12 years.
• Participants with coronavirus (SARS-CoV-2) infection confirmed ≤ 3 weeks prior to randomization by any test with local regulatory approval.
• Participants who are intubated and receiving mechanical ventilation due to COVID-19-associated ARDS and have a PaO2/FiO2 of ≤ 300 mmHg within 6 -hours of randomization.
• Participants with lung imaging showing bilateral or diffuse pulmonary infiltrates on chest x-ray or CT scan.

You may not qualify if:

• Known history of hypersensitivity to any drugs or metabolites of similar chemical classes as ruxolitinib.
• Presence of severely impaired renal function defined by estimated creatinine clearance \< 15 mL/min measured or calculated by Cockcroft-Gault equation or calculated by the updated bedside Schwartz equation. Participants must not be receiving CRRT or intermittent hemodialysis at screening.
• In the opinion of the investigator, unlikely to survive for \> 24 hours from randomization.
• Suspected active uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19).
• Currently receiving ECMO.
• Participant may not be sharing a ventilator, or co-ventilating, with any other patient.
• Treatment with anti-IL-6, IL-6R, IL-1RA, IL-1β, or GM-CSF antagonists, or a BTK inhibitor, within 7 days of randomization.
• Treatment with a JAK inhibitor within 30 days of randomization.
• Participants who are on long-term use of antirejection or immunomodulatory drugs.
• Pregnant or nursing (lactating) women.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (36)

Honor Health Research Institute

Scottsdale, Arizona, 85258, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Teradan Clinical Trials

Brandon, Florida, 33511, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

University of South Florida

Tampa, Florida, 33613, United States

Location

Northshore University Health System

Chicago, Illinois, 60678, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Indiana University Health Central Indiana Cancer Centers

Indianapolis, Indiana, 46219, United States

Location

East Jefferson General Hospital

Metairie, Louisiana, 70006, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Healthpartners Cancer Care Center - Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Mercy Research

Springfield, Missouri, 65804, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Rutgers Njms Clinical Research Unit

Newark, New Jersey, 07103, United States

Location

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

East Carolina University

Greenville, North Carolina, 27858, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Kettering Cancer Care

Dayton, Ohio, 45429, United States

Location

Jefferson University Hospitals

Philadelphia, Pennsylvania, 19107, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Allegheny Health Network

Wexford, Pennsylvania, 15090, United States

Location

St David'S Medical Center

Austin, Texas, 78705, United States

Location

University of Texas Health Science Center At Houston - McGovern Medical School

Houston, Texas, 77030, United States

Location

University of Texas Health Science Cente

San Antonio, Texas, 78229, United States

Location

Wenatchee Valley Hospital and Clinics

Wenatchee, Washington, 98801, United States

Location

Aurora Research Institute

Milwaukee, Wisconsin, 53233, United States

Location

Sbih City Hospital 15

Saint Petersburg, 198205, Russia

Location

Related Publications (1)

• Rein L, Calero K, Shah R, Ojielo C, Hudock KM, Lodhi S, Sadaka F, Bellam S, Palma C, Hager DN, Daniel J, Schaub R, O'Hayer K, Theodoropoulos NM. Randomized Phase 3 Trial of Ruxolitinib for COVID-19-Associated Acute Respiratory Distress Syndrome. Crit Care Med. 2022 Dec 1;50(12):1701-1713. doi: 10.1097/CCM.0000000000005682. Epub 2022 Oct 13.

  PMID: 36226977 DERIVED

MeSH Terms

Conditions

COVID-19; Cytokine Release Syndrome; Pneumonia

Interventions

ruxolitinib; Janus Kinase Inhibitors

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 6, 2020
• Study Start: May 24, 2020
• Primary Completion: February 26, 2021
• Study Completion: February 26, 2021
• Last Updated: January 19, 2022
• Results First Posted: January 19, 2022

Record last verified: 2022-01

Locations

US (35); RU (1)