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: Recruiting
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
RECRUITING
Orlando
Michigan
Children's Hospital of Michigan
RECRUITING
Detroit
Ohio
University Hospitals Cleveland Medical Center
ACTIVE_NOT_RECRUITING
Cleveland
Other Locations
Brazil
Centro de Pesquisa Sao Lucas
RECRUITING
Campinas
Instituto de Pesquisa clinica de Campinas
RECRUITING
Campinas
CECIP - Centro de Estudos do Interior Paulista
RECRUITING
Jaú
Hospital de Clinicas de Porto Alegre
RECRUITING
Porto Alegre
Pesquisare Saude
RECRUITING
Santo André
Mexico
Hospital Infantil de Mexico Federico Gomez
RECRUITING
Mexico City
Instituto Nacional de Pediatria
RECRUITING
Mexico City
Spain
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario La Paz
ACTIVE_NOT_RECRUITING
Madrid
Complejo Hospitalario de Navarra
ACTIVE_NOT_RECRUITING
Pamplona
Hospital Universitario de Araba (HUA)- Hospital Txagorritxu
RECRUITING
Vitoria-gasteiz
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2021-12-21
Estimated Completion Date: 2026-05
Participants
Target number of participants: 24
Treatments
Experimental: Baricitinib
Baricitinib given orally to participants daily
Authors
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company