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Baricitinib Compared to Standard Therapy in Patients With COVID-19 (BARICIVID-19)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04393051
Recruitment Status : Not yet recruiting
First Posted : May 19, 2020
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
Francesco Menichetti, Azienda Ospedaliero, Universitaria Pisana

Brief Summary:

There is urgent need of an effective therapy for Covid-19. To date, the best treatment of SARS-CoV-2 infection is unknown. Baricitinib has been identified as potential treatment for 2019-nCoV acute respiratory disease, because of its immunomodulating and hypothesized antiviral activity.

This is a multicenter randomized clinical trial that aims to evaluate the efficacy and safety of baricitinib in patients with SARS-CoV2 pneumonia. Patients will be randomized to receive or not baricitinib as adjunctive therapy. All patients will continue to receive the ongoing standard therapy: chloroquine/idrossichloroquine and low-molecular weight heparin (LMWH) eventually associated with ritonavir/lopinavir or darunavir/ritonavir will be allowed for all included patients.

The primary endpoint measure is the efficacy of baricitinib in reducing the number of patients requiring invasive ventilation after 7 and 14 days of treatment.

Secondary endpoints will be mortality rates and toxicity of baricitinib.


Condition or disease Intervention/treatment Phase
Covid-19 SARS-CoV 2 SARS Pneumonia Drug: Baricitinib Oral Tablet Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase II randomized clinical trial to evaluate the efficacy and safety of baricitinib in patients with SARS-CoV2 pneumonia
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BARICIVID-19 STUDY: MultiCentre, Randomised, Phase IIa Clinical Trial Evaluating Efficacy and Tolerability of Baricitinib as add-on Treatment of In-patients With COVID-19 Compared to Standard Therapy
Estimated Study Start Date : May 20, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 30, 2020

Arm Intervention/treatment
Experimental: BAR group

Patients who will be assigned (after a computerized randomization) to the BAR group will. receive baricitinib as adjunctive therapy.

Baricitinib will be administered at 4 mg daily via oral route for 14 days as add-on therapy or 2 mg daily via oral route (eGFR between 30 and 60 ml/min and for patients with age >75 years old) for 14 days as add-on therapy

Drug: Baricitinib Oral Tablet
Baricitinib will be administered by oral route at different dosages according to age and kidney function. The drug will be administered for 14 days, unless occurrence of discontinuation criteria.

No Intervention: Control group
Patients in the control group will continue to receive standard therapy.



Primary Outcome Measures :
  1. Need of invasive mechanical ventilation [ Time Frame: after 7 and 14 days of treatment ]
    Reduction of the number of patients requiring invasive ventilation


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 14- and 28-days from randomization ]
    Proportion of any cause deaths

  2. Time to invasive mechanical ventilation [ Time Frame: 30 days ]
    Days from randomization to invasive mechanical ventilation

  3. Time to independence from non-invasive mechanical ventilation [ Time Frame: 30 days ]
    Days from randomization to independence from non-invasive mechanical ventilation

  4. Time to independence from oxygen therapy [ Time Frame: 30 days ]
    Days from randomization to independence from oxygen therapy

  5. Time to improvement in oxygenation for at least 48 hours [ Time Frame: 30 days ]
    Days from randomization to improvement in oxygenation for at least 48 hours

  6. Length of hospital stay [ Time Frame: 30 days ]
    Days of hospital stay

  7. Length of ICU stay [ Time Frame: 30 days ]
    Days of ICU stay

  8. Instrumental response [ Time Frame: 30 days ]
    Changes in pulmonary echography

  9. Proportion of adverse events [ Time Frame: 30 days ]
    Rate of adverse events codified by Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any gender
  • Age > 18 years on day of signing informed consent
  • Informed written consent for participation in the study
  • Virological diagnosis of SARS-CoV-2 infection (real-time PCR)
  • Hospitalized due to clinical instrumental diagnosis of pneumonia.
  • Oxygen saturation at rest in ambient air ≤93% or P/F ratio <250
  • Able to be administered by oral route drugs
  • Patients who receive O2 therapy or who need non-invasive mechanical ventilation
  • In case of female patients at childbearing potential, they should agree to use highly effective methods of birth control at least till 7 days after the termination of the treatments

Exclusion Criteria:

  • Known hypersensitivity to Baricitinib or its excipients
  • Patients with Creatinine Clearance < 30 ml/min
  • Patients with active Tuberculosis (TBC)
  • Patients with known HBV or HCV infection
  • Patients with deep vein thrombosis (DVP) or Pulmonary Embolism (PE)
  • Patients with ALT or AST> 5 times the upper limit of the normality
  • Neutrophils <1000/mmc
  • Platelets <50.000/mmc
  • Hb< 8g/dl
  • Bowel diverticulitis or perforation
  • Patients who receive invasive mechanical ventilation
  • Documented bacterial infection at time of randomization
  • Patients with "do not resuscitate order"
  • Patients receiving immunosuppressants or anti-rejection drugs
  • Pregnancy or breastfeeding

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): NCT04393051


Contacts
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Contact: Marco Falcone, MD 050996735 marco.falcone@unipi.it
Contact: Giusy Tiseo, MD 050996343 tiseogiusy@gmail.com

Locations
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Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56126
Contact: Marco Falcone       marco.falcone@unipi.it   
Principal Investigator: Francesco Menichetti         
Sub-Investigator: Marco Falcone         
Sponsors and Collaborators
Azienda Ospedaliero, Universitaria Pisana
Investigators
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Principal Investigator: Francesco Menichetti, MD Azienda Ospedaliero, Universitaria Pisana
Publications of Results:
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Responsible Party: Francesco Menichetti, Professor, Azienda Ospedaliero, Universitaria Pisana
ClinicalTrials.gov Identifier: NCT04393051    
Other Study ID Numbers: BARICIVID-19
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Francesco Menichetti, Azienda Ospedaliero, Universitaria Pisana:
baricitinib
invasive ventilation
safety
pneumonia
SARS-CoV2
Covid-19
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections