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A Multicenter, Open-Label, Pharmacokinetic and Safety Study of Baricitinib in Pediatric Patients from 1 Year to Less Than 18 Years Old Hospitalized with COVID-19

A Multicenter, Open-Label, Pharmacokinetic and Safety Study of Baricitinib in Pediatric Patients from 1 Year to Less Than 18 Years Old Hospitalized with COVID-19

  • Clinical Trial Information

    Trial Contact: Tilme, Linda

    Trial Phone: 321.843.5278

  • IRB No: S21.166.10

    Protocol Abbrev: I4V-MC-KHAB

    Principal Investigator: Federico Ricardo Laham, MD

    Phase: Drug: Phase III

    Age Group: Pediatric

    Secondary Protocol No: I4V-MC-KHAB

    Treatment: baricitinib (LY3009104)

    Therapies Involved: Medication

  • Objective

    To characterize the pharmacokinetics (PK) of baricitinib* in pediatric patients with COVID-19. To describe the effect of baricitinib* on COVID-19 progression in pediatric patients

  • Key Eligibility

    *male or female patients from 1 to <18 years of age (inclusive)
    *Hospitalized with coronavirus (SARS-CoV-2) infection, confirmed by NAAT such as real-time reverse-transcription polymerase chain reaction (rt-PCR) tests or immunodiagnostic tests detecting viral structural protein antigens such as nucleocapsid protein antigen spike (S) or other structural protein antigens. All SARS-CoV-2 virus NAAT or immunodiagnostics tests must be certified for diagnostic testing in compliance with local and national regulation, with a positive result in a sample collected no more than 14 days prior to treatment assignment.
    *Hospitalized with coronavirus (SARS-CoV-2) infection, confirmed by NAAT such as real-time reverse-transcription polymerase chain reaction (rt-PCR) tests or immunodiagnostic tests detecting viral structural protein antigens such as nucleocapsid protein antigen spike (S) or other structural protein antigens. All SARS-CoV-2 virus NAAT
    or immunodiagnostics tests must be certified for diagnostic testing in compliance with local and national regulation, with a positive result in a sample collected no more than 14 days
    prior to treatment assignment.