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

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ClinicalTrials.gov Identifier: NCT04320277
Recruitment Status : Not yet recruiting
First Posted : March 24, 2020
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Fabrizio Cantini, Hospital of Prato

Tracking Information
First Submitted Date  ICMJE March 20, 2020
First Posted Date  ICMJE March 24, 2020
Last Update Posted Date April 22, 2020
Estimated Study Start Date  ICMJE May 16, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2020)		 The percentage of patients requiring transfer to ICU as compared with the rate of transfers observed in controls. [ Time Frame: 2 weeks ]
The percentage of ICU admission in patients and controls will be compared for statistical difference
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2020)		 The percentage of patients achieving the remission; CRP, IL-6 and TNFα values at baseline and during the treatment course; the number of AEs. [ Time Frame: 2 weeks ]
CRP values will be evaluated for prediction of disease worsening.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Baricitinib in Symptomatic Patients Infected by COVID-19: an Open-label, Pilot Study.
Official Title  ICMJE Baricitinib Combined With Antiviral Therapy in Symptomatic Patients Infected by COVID-19: an Open-label, Pilot Study
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE 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.

Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pharmacological Action
Intervention  ICMJE 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 Name: Lopinavir/Ritonavir tablets 250 mg/bid
Study Arms  ICMJE
  • Experimental: Patients
    All patients received baricitinib combined to antiviral therapy lopinavir/ritonavir for 2 weeks.
    Intervention: Drug: Baricitinib
  • 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.
    Intervention: Drug: Baricitinib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 19, 2020)		 200
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2020)		 60
Estimated Study Completion Date  ICMJE July 30, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Fabrizio Cantini, MD +393408075607 fbrzcantini@gmail.com
Contact: Laura Niccoli, MD +39 3339849690 lniccoli64@gmail.com
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04320277
Other Study ID Numbers  ICMJE HPrato-3
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fabrizio Cantini, Hospital of Prato
Study Sponsor  ICMJE Hospital of Prato
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Fabrizio Cantini, MD Hospital of Prato, Italy
PRS Account Hospital of Prato
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP