Ruxolitinib to Combat COVID-19

• Status: Withdrawn
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: Incyte Corporation

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.