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
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Clinical Trial Information
Trial Contact: Tilme, Linda
Trial Phone: 321.843.5278
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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
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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
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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.
