Ruxolitinib to Combat COVID-19

NCT04354714 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 04-13-20-DiPersio
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators hypothesize that JAK 1/2 inhibition with ruxolitinib, an FDA approved treatment for intermediate or high-risk myelofibrosis, could have a similar effect in patients with severe COVID-19, quelling the immune-hyperactivation, allowing for clearance of the virus and reversal of the disease manifestations.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Through 28 days

Secondary Outcomes (11)

• Length of hospital stay

  Through completion of follow-up (estimated to be 7 months)

• Length of ICU stay

  Through completion of follow-up (estimated to be 7 months)

• Duration of ventilator use

  Through completion of follow-up (estimated to be 7 months)

• Duration of vasopressors use

  Through completion of follow-up (estimated to be 7 months)

• Duration on renal replacement therapy

  Through completion of follow-up (estimated to be 7 months)

Study Arms (1)

Ruxolitinib

EXPERIMENTAL

-Ruxolitinib is an oral medication that will be given twice daily (BID). Dosing on Days 1 through 3 will be 5 mg BID; dosing on Days 4 through 10 will be 10 mg BID.

Drug: Ruxolitinib; Procedure: Peripheral blood draw

Interventions

Ruxolitinib DRUG

For patients unable to swallow pills, a ruxolitinib suspension will be administered through a nasogastric/orogastric tube

Also known as: Jakafi

Ruxolitinib

Peripheral blood draw PROCEDURE

-Screening, Day 2, Day 4, Day 8, Day 15, and Day 29

Ruxolitinib

Eligibility Criteria

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

You may qualify if:

• A diagnosis of advanced COVID-19 as defined by both of the following:
• A positive test for SARS-CoV-2 RNA detected by RT-PCR collected from the upper respiratory tract (nasopharyngeal and oropharyngeal swab) and, if possible, the lower respiratory tract (sputum, tracheal aspirate, or bronchoalveolar lavage), analyzed by a CLIA certified lab
• Critical disease manifested by any of the following:
• Chest imaging (CT or chest X-ray permitted) with ≥ 50% lung involvement
• Respiratory failure requiring invasive mechanical ventilation or supplementary oxygen with FiO2 ≥ 50%
• Shock (defined as mean arterial pressure ≤ 65 mmHg unresponsive to 25ml/kg isotonic intravenous fluid resuscitation and/or requiring vasopressor support
• Cardiac dysfunction defined by:
• New global systolic dysfunction with ejection fraction ≤ 40%
• Takotsubo cardiomyopathy
• New onset supraventricular or ventricular arrhythmias
• Plasma troponin I ≥ 0.10 ng/mL in someone without previously documented troponin elevation beyond that level
• Elevated plasma NT-proBNP in someone without documented prior elevation
• If Age \< 50, NT-proBNP \> 450 pg/ml
• If Age 50-74, NT-proBNP \> 900 pg/ml
• If Age ≥ 74, NT-proBNP \> 1800 pg/ml

You may not qualify if:

• Known allergy or intolerance to ruxolitinib or another JAK inhibitor.
• Known or suspected active viral (including HIV, hepatitis B, and hepatitis C), bacterial, mycobacterial, or fungal infection other than COVID-19. Virologic testing not required unless infection is suspected.
• Pregnant and/or breastfeeding.
• Any uncontrolled intercurrent illness that would put the patient at greater risk or limit compliance with study requirements in the opinion of the investigator.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Incyte Corporation: collaborator

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

COVID-19

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• John DiPersio, M.D., Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 21, 2020
• Study Start: June 30, 2020
• Primary Completion: July 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share