Ruxolitinib to Combat COVID-19

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.