Safety and Efficacy of Baricitinib for COVID-19

University of Colorado Denver (CU Denver)

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: COVID-19

Treatments: Drug: Baricitinib

Study type: Interventional

Funder types: Other

Identifiers

NCT04340232

20-0738

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Baricitinib Arm

Experimental group

Description:

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, whichever occurs first. Participants who are discharged will be followed up with via phone on Day 15 and Day 29.

Treatment:

Drug: Baricitinib