Safety and Efficacy of Baricitinib for COVID-19

Official Summary

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.

Eligibility Requirements

• Minimum Age: 18 Years
• Maximum Age: 89 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE

Study Arms

• Baricitinib Arm (EXPERIMENTAL)
  This study is an Adaptive Phase 2/3 trial designed to test the safety (Phase 2) and efficacy (Phase 2 and 3) of baricitinib to treat COVID-19. Phase 2 consists of a single-arm, open-label assignment of 20 participants receiving 2 mg baricitinib once daily for 14 days. Phase 3 consists of a single-arm, open-label assignment of 60 additional participants receiving baricitinib at the same dose. In both phases, participants will be monitored daily while hospitalized for 29 days, or until discharge,

Interventions

• DRUG: Baricitinib — Subjects will receive a 2 mg oral dose of baricitinib.

Primary Outcomes

• Phase 2: Cumulative incidence of Grade 3 and 4 adverse events (AEs) (Day 0 (screening) through Day 29)
• Phase 2: Cumulative incidence of serious adverse events (SAEs) (Day 0 (screening) through Day 29)
• Phase 2: Changes in white blood cell count (CBC) through Day 15 (Day 1 to Day 15)
• Phase 2: Changes in hemoglobin through Day 15 (Day 1 to Day 15)
• Phase 2: Changes in platelets through Day 15 (Day 1 to Day 15)

Secondary Outcomes

• Phase 2: Change in the 8-point ordinal scale (Day 1 to Day 29)
• Phase 2: Change in National Early Warning Score (NEWS) (Day 1 through Day 29 or hospital discharge, whichever is first)
• Phase 3: Change in the 8-point ordinal scale (Day 1 to Day 29)
• Phase 3: Change in National Early Warning Score (NEWS) (Day 1 to Day 29 or hospital discharge, whichever is first)
• Phase 3: Time to an improvement of one category using the 8-point ordinal scale (Day 1 to Day 29 or hospital discharge, whichever is first)

Eligibility Criteria

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)

Trial Locations

• University of Colorado, Denver, Aurora, Colorado, United States

Study Officials

• Joaquin Espinosa, PhD — PRINCIPAL_INVESTIGATOR
  University of Colorado, Denver

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