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

Trial Profile

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

Status: Not yet recruiting
Phase of Trial: Phase II/III

Latest Information Update: 23 Apr 2020

At a glance

  • Drugs Baricitinib (Primary) ; Lopinavir/ritonavir (Primary)
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Acronyms BARI-COVID
  • Most Recent Events

    • 19 Apr 2020 Planned number of patients changed from 60 to 200.
    • 19 Apr 2020 Planned End Date changed from 30 Apr 2020 to 30 Jul 2020.
    • 19 Apr 2020 Planned primary completion date changed from 30 Apr 2020 to 30 Jun 2020.

Trial Overview

Purpose

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.

Primary Endpoints

The percentage of patients requiring transfer to ICU as compared with the rate of transfers observed in controls.

description: The percentage of ICU admission in patients and controls will be compared for statistical difference
time_frame: 2 weeks

Other Endpoints

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

description: CRP values will be evaluated for prediction of disease worsening.
time_frame: 2 weeks [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 200

  • Sex male & female
  • Age Group 18-85 years; adult; elderly

Patient 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.

Patient Exclusion Criteria

- Age less than 18 - History of thrombophlebitis. - Patient with latent tuberculosis infection (Quantiferon test). - Pregnancy and lactation.

Trial Details

Identifiers

Identifier Owner
NCT04320277 ClinicalTrials.gov: US National Institutes of Health
HPrato3 -

Trial Dates

  • Initiation Dates

    Planned : 16 May 2020

  • Primary Completion Dates

    Planned : 30 Jun 2020

  • End Dates

    Planned : 30 Jul 2020

Other Details

  • Design crossover; open; prospective
  • Phase of Trial Phase II/III
  • Location Italy
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
BaricitinibPrimary Drug Oral Tablet
Lopinavir/ritonavirPrimary Drug Oral Tablet

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

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

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Fabrizio Cantini
+39 3408075607
fbrzcantini@gmail.com
show details
Fabrizio Cantini Italy
Fabrizio Cantini, MD
+393408075607
fbrzcantini@gmail.com
show details
Hospital of Prato, Italy
-
Laura Niccoli, MD
+39 3339849690
lniccoli64@gmail.com
show details
-

Centres

Centre Name Location Trial Centre Country
-
-
-
Fabrizio Cantini Prato, Tuscany Italy
Hospital of Prato
-
-
Hospital of Prato, Italy
-
-

Trial History

Event Date Event Type Comment
23 Apr 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 23 Apr 2020
19 Apr 2020 Other trial event Planned number of patients changed from 60 to 200. Updated 23 Apr 2020
19 Apr 2020 Completion date Planned End Date changed from 30 Apr 2020 to 30 Jul 2020. Updated 23 Apr 2020
19 Apr 2020 Other trial event Planned primary completion date changed from 30 Apr 2020 to 30 Jun 2020. Updated 23 Apr 2020
19 Apr 2020 Other trial event Planned initiation date changed from 16 Mar 2020 to 16 May 2020. Updated 23 Apr 2020
19 Apr 2020 Status change - not yet recruiting Status changed from recruiting to not yet recruiting. Updated 23 Apr 2020
27 Mar 2020 New trial record New trial record Updated 27 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
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