Ruxolitinib to Combat COVID-19

NCT ID: NCT04354714

Last Updated: 2020-05-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2021-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ruxolitinib

-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.

Group Type: EXPERIMENTAL

Ruxolitinib

Intervention Type: DRUG

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

Peripheral blood draw

Intervention Type: PROCEDURE

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

Interventions

Ruxolitinib

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

Intervention Type: DRUG

Peripheral blood draw

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

Intervention Type: PROCEDURE

Other Intervention Names

Jakafi

Eligibility Criteria

Inclusion Criteria

• 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
• Receipt of investigational or off-label agents for COVID-19 (prior or ongoing) does not exclude eligibility.
• Patients who have received autologous or allogeneic stem cell transplant are eligible at the discretion of the investigators.
• 18 years of age or older at the time of study registration
• Adequate hematologic function defined as:

• absolute neutrophil count ≥ 1000/mm3
• platelet count ≥ 50,000/mm3 without growth factor or transfusion support for 7 days prior to screening
• Creatinine clearance ≥ 15 mL/minute or receiving renal replacement therapy
• Women of childbearing potential (defined as women with regular menses, women with amenorrhea, women with irregular cycles, women using a contraceptive method that precludes withdrawal bleeding, or women who have had a tubal ligation) are required to have a negative pregnancy test and use two forms of acceptable contraception, including one barrier method, during participation in the study treatment period.
• Male patients (if engaging in reproductive sex with a women of childbearing potential) are required to use two forms of acceptable contraception, including one barrier method, during participation in the study and throughout the evaluation period.
• Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable)

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John DiPersio, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Related Links

http://www.siteman.wustl.edu

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

Other Identifiers

04-13-20-DiPersio

Identifier Type: -

Identifier Source: org_study_id