To provide ruxolitinib through an expanded access program for the treatment of cytokine storm due to COVID-19 in the United States to patients who are eligible but not able to be hospitalized or who are hospitalized with a clinical diagnosis and/or positive test for SARD-CoV-2 infection.
Drug: Ruxolitinib
Ruxolitinib starting dose level 5 mg orally, twice daily (BID).
Other Name: INCB018424
Inclusion Criteria:
- Male or female, 12 years of age or older.
- Clinical diagnosis of COVID-19 and/or locally accepted positive test; if feasible,
swab should be taken and saved for quantitative testing to determine viral load.
- Disease severity making the patient eligible for hospitalization (whether or not
hospitalization is available), with evidence of cytokine storm as determined by the
treating physician. Manifestations of cytokine storm can include the following:
- Severe shortness of breath (respiratory rate > 24 breaths/minute).
- SpO2 of < 90% on ambient air.
- Need for invasive or noninvasive mechanical ventilation.
- Acute respiratory distress syndrome.
- Multiple organ failure.
- Be willing to avoid pregnancy or fathering children
- Able to provide written informed consent, consent from the patient's legally
authorized representative, and/or assent from the patient, parent, or guardian.
Exclusion Criteria:
- Patients, patient's legally authorized representative, or legal guardians unable to
review and sign ICF.
- Females who are pregnant or breastfeeding, and males and females who cannot comply
with requirements to avoid fathering a child or becoming pregnant.
- Patients with inadequate liver function (ALT above 4 × ULN or direct bilirubin 4 × ULN
and the laboratory abnormalities are considered to be due to underlying liver
dysfunction).
- Patients with platelet counts < 50 × 109 /L
- Any underlying or current medical or psychiatric condition that, in the opinion of the
treating physician, would place the patient at an unacceptable risk if he or she were
to participate in the program.
- Previous allergic reactions to JAK inhibitors or excipients.
- Concomitant use of any other JAK inhibitor.
- Is eligible or able to access ruxolitinib through an Incyte-sponsored clinical study
or is eligible for another therapeutic clinical trial for cytokine storm at the
treating institution..