Baricitinib Combined With Antiviral Therapy in Symptomatic Patients Infected by COVID-19: an Open-label, Pilot Study

Official Summary

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.

Eligibility Requirements

• Minimum Age: 18 Years
• Maximum Age: 85 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: CROSSOVER
• Masking: NONE
• Enrollment: 200 participants

Study Arms

• Patients (EXPERIMENTAL)
  All patients received baricitinib combined to antiviral therapy lopinavir/ritonavir for 2 weeks.
• Controls (ACTIVE_COMPARATOR)
  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.

Interventions

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

Primary Outcomes

• The percentage of patients requiring transfer to ICU as compared with the rate of transfers observed in controls. (2 weeks)

Secondary Outcomes

• The percentage of patients achieving the remission; CRP, IL-6 and TNFα values at baseline and during the treatment course; the number of AEs. (2 weeks)

Eligibility Criteria

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 Locations

• Fabrizio Cantini, Prato, Tuscany, Italy

Contact Information

• Fabrizio Cantini, MD — CONTACT
  Phone: +393408075607
  Email: fbrzcantini@gmail.com
• Laura Niccoli, MD — CONTACT
  Phone: +39 3339849690
  Email: lniccoli64@gmail.com

Study Officials

• Fabrizio Cantini, MD — STUDY_DIRECTOR
  Hospital of Prato, Italy

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