Baricitinib in Symptomatic Patients Infected by COVID-19: an Open-label, Pilot Study. (BARI-COVID)

Hospital of Prato

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Pharmacological Action

Treatments: Drug: Baricitinib

Study type: Interventional

Funder types: Other

Identifiers

NCT04320277

HPrato-3

Details and patient eligibility

About

There is no specific antiviral treatment recommended for COVID-19, and no vaccine is currently available. Baricitinib, an anti-Janus kinase inhibitor (anti-JAK) acting against JAK1 and JAK2. The drug was found capable to reduce or interrupt the passage of the virus into target cells, and to inhibit the JAK1- and JAK2-mediated cytokine release. The drug was licensed for the treatment of rheumatoid arthritis at the daily dose of 4 mg/orally, with excellent results in terms of clinical response and a good safety profile. Since baricitinib does not interact with antivirals due to its prevalent renal elimination, it may be used in combination.The evidence on the advantageous action of baricitinib on viral entry and cytokine outbreak constituted the rationale to perform a trial on patients with mild to moderate COVID-19 infection receiving baricitinib combined with antiviral therapy.

Full description

Study design. Interventional, open-label, 2-week, prospective trial of a cohort of patients with mild to moderate COVID-19 infection.

Objectives. Primary. To assess the efficacy of baricitinib combined with antiviral therapy in patients with COVID-19-related mild and moderate disease in terms of reduction of the percentage of subjects requiring ICU admission.

Secondary objectives. To describe the clinical findings in a cohort of symptomatic COVID-19-infected subjects; to investigate the role of CRP, IL-6, and TNFα levels as predictor of progression to ARDS; to assess the type and incidence of adverse events (AEs).

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All consecutive patients with mild to moderate COVID-19 infection
• Age >18 years,
• Clinical diagnosis of COVID19 infection
• Patients should present fever, cough and myalgia and weakness and radiological findings of pneumonia.
• All patients should be willing and able to provide written informed consent prior to performing study procedures.

Exclusion criteria

• Age less than 18
• History of thrombophlebitis.
• Patient with latent tuberculosis infection (Quantiferon test).
• Pregnancy and lactation.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Patients

Experimental group

Description:

All patients received baricitinib combined to antiviral therapy lopinavir/ritonavir for 2 weeks.

Treatment:

Drug: Baricitinib

Controls

Active Comparator group

Description:

All consecutive patients with mild to moderate COVID-19 infection, older than 18, a during the previous 2 weeks, who were treated with antiviral and/or hydroxychloroquine.

Treatment:

Drug: Baricitinib