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

Sponsor
Hospital of Prato
Study ID
NCT04320277
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

  • Pharmacological Action

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib — DRUG
    Baricitinib 4 mg/day/orally combined to antiviral therapy ritonavir for 2 weeks. Baricitinib tablets 4 mg were administered in the morning.

Study Details

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.

Key Dates

Start date
May 16, 2020
Status verified
Apr 2020
Primary completion
Jun 30, 2020
Completion
Jul 30, 2020

Study Design

Enrollment
200 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Patients
    All patients received baricitinib combined to antiviral therapy lopinavir/ritonavir for 2 weeks.
  • Active Comparator: Controls
    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.

Primary Outcome Measure

The percentage of patients requiring transfer to ICU as compared with the rate of transfers observed in controls. [ Time Frame: 2 weeks ]

Central Contacts