This study plans to learn more about the effects of a medicine called ruxolitinib on the progression of COVID-19 (coronavirus disease of 2019), the medical condition caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Ruxolitinib is FDA-approved for the treatment of myelofibrosis, polycythemia vera, and graft-versus-host disease. This study intends to define the impact of ruxolitinib on the severity and progression of COVID-19. This drug might to lower the hyperinflammation caused by the virus, which would prevent damage to the lungs and possibly other organs. The study will recruit patients who have been diagnosed with COVID-19. The goal is to recruit 80 patients.
This is an adaptive Phase 2/3 clinical trial, with a focus on the assessment of safety in the
first 20 participants (Phase 2), followed by a much broader assessment of efficacy, while
continuing to monitor safety, in an additional 60 participants (Phase 3, total participants
across Phase 2/3 n=80). Both phases are single arm, open label, and occur at a single site at
the University of Colorado Hospital (UCH). Data from participants in this study will be
compared with data from other COVID-19 patients not receiving ruxolitinib. Study participants
will receive 10 mg twice daily of ruxolitinib for 14 days and will be followed for up to 29
days.
Drug: Ruxolitinib
Participants will receive 10 mg ruxolitinib twice daily.
Other Name: Array
Inclusion Criteria:
- Male or female aged 18 - 89 years at time of enrollment
- Hospitalized (or documented plan to hospitalize if patient is in the emergency
department) with symptoms suggestive of COVID-19
- lllness of any duration that meets each of the following:
- Evidence of pneumonia, including radiographic infiltrates by imaging (chest x-ray, CT
scan, etc.) or clinical assessment (rales/crackles on exam)
- Requires supportive care, including non-invasive supplemental oxygen
- Laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial or
public health assay within 7 days of enrollment
- Understands and agrees to comply with planned study procedures
- Provides informed consent signed by study patient or legally acceptable representative
Exclusion Criteria:
- Absolute platelet counts are less than 75 x 10^9/L
- Absolute neutrophil count is less than 0.5 x 10^9/L
- Hemoglobin is less than 8 g/dL
- Severe renal impairment defined by serum creatinine greater than 2 mg/dL or CrCl less
than 30 mL/min
- Treatment with other JAK inhibitors, strong CYP3A4 inhibitors, biologic
disease-modifying anti-rheumatic drugs (DMARDs, including anti-IL-6 or anti-IL-6R
antibodies), or potent immunosuppressants such as azathioprine and cyclosporine
concurrently or within the past 5 days. Note: recent or concurrent treatment with
hydroxychloroquine or chloroquine is allowable, as these are 'non-biologic' DMARDs
with potential antiviral activity.
- History of HIV infection and on active immunosuppressant therapy
- Current hematological or solid organ malignancy and on active immunosuppressant
therapy
- Active tuberculosis (TB) infection or known or suspected systemic bacterial or fungal
infection
- Pregnancy or breast feeding
- Known allergy to ruxolitinib
- In the opinion of the investigator, they are unlikely to survive for >48 hours from
screening
- Any physical examination findings and/or history of any illness that, in the opinion
of the investigator, might confound the results of the study or pose an additional
risk to the patient by their participation in the study
Additional Exclusion Criteria for Phase 2 only:
- Invasive oxygen supplementation, including mechanical ventilation and extracorporeal
membrane oxygenation (ECMO)
Joaquin Espinosa, PhD, Principal Investigator
University of Colorado, Denver