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
Who is this study for? Patients with Covid19
What treatments are being studied? Baricitinib
Status: Terminated
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose for this study is to determine if the study drug baricitinib is effective and safe in hospitalized pediatric participants with Coronavirus disease 2019 (COVID -19) and to confirm the dose.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 18
Healthy Volunteers: f
View:
• Hospitalized with coronavirus (SARS-CoV-2) infection.
• Male or female participants from 1 to \<18 years of age.
• Requires supplemental oxygen and have chest imaging findings to confirm respiratory disease due to COVID-19 within 72 hours of study entry and enrollment.
• Supplemental oxygen including but not limited to: nasal cannula, mask, high flow devices, CPAP/BiPAP, invasive mechanical ventilation as well as ECMO.
Locations
United States
Florida
Arnold Palmer Hospital for Children
Orlando
Michigan
Children's Hospital of Michigan
Detroit
Ohio
University Hospitals Cleveland Medical Center
Cleveland
Other Locations
Brazil
Centro de Pesquisa Sao Lucas
Campinas
Instituto de Pesquisa clinica de Campinas
Campinas
CECIP - Centro de Estudos do Interior Paulista
Jaú
Hospital de Clinicas de Porto Alegre
Porto Alegre
Pesquisare Saude
Santo André
Mexico
Hospital Infantil de Mexico Federico Gomez
Mexico City
Instituto Nacional de Pediatria
Mexico City
Spain
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario La Paz
Madrid
Complejo Hospitalario de Navarra
Pamplona
Hospital Universitario de Araba (HUA)- Hospital Txagorritxu
Vitoria-gasteiz
Time Frame
Start Date: 2021-12-21
Completion Date: 2024-11-04
Participants
Target number of participants: 6
Treatments
Experimental: Baricitinib
Baricitinib given orally to participants daily
Authors
Manoj Harishchandra Bhatnagar, Jocelyn Ang, Lemuel Aigbivbalu, Federico Ricardo Laham, Roberto Parulan Santos, Mary Fairchok, Karen Miller, Ankita Desai, Abiel Homero Mascarenas De Los Santos, Benoit FLORKIN, Balasubramanian Sundaram, Eduardo Sprinz, PABLO ROJO, Ana Mendez-Echevarria, Kapil Zirpe, Jose Francisco Kerr Saraiva
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company