This study plans to learn more about the effects of a medicine called baricitinib 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). Baricitinib is FDA-approved for the treatment of rheumatoid arthritis, an autoimmune condition. This study intends to define the impact of baricitinib 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 baricitinib. Study participants
will receive 2 mg/day of baricitinib for 14 days and will be followed for up to 29 days.
Drug: Baricitinib
Subjects will receive a 2 mg oral dose of baricitinib.
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
- Illness of any duration that meets each of the following:
1. Evidence of pneumonia, including radiographic infiltrates by imaging (chest
x-ray, CT scan, etc.) or clinical assessment (rales/crackles on exam)
2. 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 lymphocyte count is less than 500 cells/mm
- Absolute neutrophil count is less than 1000 cells/mm
- Hemoglobin level is less than 8 g/dL
- Estimated GFR is less than 60 mL/min/1.73 m2
- ALT or AST is over 5 times the upper limit of normal
- Treatment with other JAK inhibitors, OAT3 inhibitors, biologic disease-modifying
anti-rheumatic drugs (DMARDs), 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 baricitinib
- 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)
University of Colorado, Denver
Aurora, Colorado, United States
Joaquin Espinosa, PhD, Principal Investigator
University of Colorado, Denver