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

Sponsor
Hospital of Prato (Other)
Overall Status
Unknown status
CT.gov ID
NCT04320277
Collaborator
(none)
200
1
2
2.5
81.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed 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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Patients. All consecutive patients with mild to moderate COVID-19 infection, older than 18, Patients should present fever, cough and myalgia and weakness and radiological findings of pneumonia. Controls. All consecutive patients with mild to moderate COVID-19 infection, older than 18, admitted during the previous 2 weeks, who were treated with antiviral and/or hydroxychloroquine.Patients. All consecutive patients with mild to moderate COVID-19 infection, older than 18, Patients should present fever, cough and myalgia and weakness and radiological findings of pneumonia. Controls. All consecutive patients with mild to moderate COVID-19 infection, older than 18, admitted during the previous 2 weeks, who were treated with antiviral and/or hydroxychloroquine.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Baricitinib Combined With Antiviral Therapy in Symptomatic Patients Infected by COVID-19: an Open-label, Pilot Study
Anticipated Study Start Date :
May 16, 2020
Anticipated Primary Completion Date :
Jun 30, 2020
Anticipated Study Completion Date :
Jul 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients

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

Drug: Baricitinib
Baricitinib 4 mg/day/orally combined to antiviral therapy ritonavir for 2 weeks. Baricitinib tablets 4 mg were administered in the morning.
Other Names:
  • Lopinavir/Ritonavir tablets 250 mg/bid
  • 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.

    Drug: Baricitinib
    Baricitinib 4 mg/day/orally combined to antiviral therapy ritonavir for 2 weeks. Baricitinib tablets 4 mg were administered in the morning.
    Other Names:
  • Lopinavir/Ritonavir tablets 250 mg/bid
  • Outcome Measures

    Primary Outcome Measures

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

      The percentage of ICU admission in patients and controls will be compared for statistical difference

    Secondary Outcome Measures

    1. 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]

      CRP values will be evaluated for prediction of disease worsening.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fabrizio Cantini Prato Tuscany Italy 59100

    Sponsors and Collaborators

    • Hospital of Prato

    Investigators

    • Study Director: Fabrizio Cantini, MD, Hospital of Prato, Italy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Fabrizio Cantini, Head of Rheumatology Department, Principal investigator, Hospital of Prato
    ClinicalTrials.gov Identifier:
    NCT04320277
    Other Study ID Numbers:
    • HPrato-3
    First Posted:
    Mar 24, 2020
    Last Update Posted:
    Apr 22, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fabrizio Cantini, Head of Rheumatology Department, Principal investigator, Hospital of Prato
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 22, 2020