Ruxolitinib to Combat COVID-19

The Washington University

Status and phase: Withdrawn; Phase 2

Conditions: COVID-19

Treatments: Drug: Ruxolitinib; Procedure: Peripheral blood draw

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04354714

04-13-20-DiPersio

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Ruxolitinib

Experimental group

Description:

-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.

Treatment:

Procedure: Peripheral blood draw

Drug: Ruxolitinib