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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04320277
Recruitment Status : Unknown
Verified April 2020 by Fabrizio Cantini, Hospital of Prato.
Recruitment status was:  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

Study Description
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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
Pharmacological Action Drug: Baricitinib 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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
Estimated Study Start Date : May 16, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Lopinavir/Ritonavir tablets 250 mg/bid


Outcome Measures
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Primary Outcome Measures :
  1. 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


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. [ Time Frame: 2 weeks ]
    CRP values will be evaluated for prediction of disease worsening.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04320277


Contacts
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Contact: Fabrizio Cantini, MD +393408075607 fbrzcantini@gmail.com
Contact: Laura Niccoli, MD +39 3339849690 lniccoli64@gmail.com

Locations
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Italy
Fabrizio Cantini
Prato, Tuscany, Italy, 59100
Contact: Fabrizio Cantini    +39 3408075607    fbrzcantini@gmail.com   
Sponsors and Collaborators
Hospital of Prato
Investigators
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Study Director: Fabrizio Cantini, MD Hospital of Prato, Italy
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: March 24, 2020    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fabrizio Cantini, Hospital of Prato:
COVID-19
Baricitinib
Moderate disease
Infection
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Ritonavir
 Lopinavir
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors