EUCTR2021-001338-21-BE
Active, not recruiting
Phase 1
A Multicenter, Open-Label, Pharmacokinetic and Safety Study of Baricitinib in Pediatric Patients from 1 Year to Less Than 18 Years Old Hospitalized withCOVID-19 - COV-BARRIER-PEDS
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Eli Lilly and Company
- Enrollment
- 24
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Male or female patients from 1 to \<18 years of age at the time of enrollment
- •\- Hospitalized with coronavirus (SARS\-CoV\-2\) infection, confirmed by NAAT or immunodiagnostic tests, with a positive result in a sample collected no more than 14 days prior to treatment assignment
- •\- Require supplmental oxygen and have chest imaging findings to confirm respiratory disease due to COVID\-19 within 72 hours of study entry and enrollment
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 24
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range 0
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range 0
Exclusion Criteria
- •\- Are receiving biologic treatments (such as TNF inhibitors, interleukin inhibitors, T\-cell or B\-cell targeted therapies, interferons, or JAK inhibitors) for any indication at study entry; or are receiving other immunosuppressants such that, in the opinion of the investigator, participating in the study would put the participant at an unacceptable risk of immunosuppression. Note: A washout period is required prior to screening.
- •\- Are receiving strong inhibitors of OAT3 (such as probenecid) that cannot be discontinued at study entry.
- •\- Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti\-tuberculosis therapy per local guidelines (by history only, no screening tests required)
- •\- Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID\-19\) that in the opinion of the investigator could constitute a risk when taking investigational product
- •\- Have received any live vaccine within 4 weeks before screening, or intend to receive a live vaccine during the study. Note: use of nonlive (inactivated) vaccinations is allowed for all participants
- •\- Require invasive mechanical ventilation, including extracorporeal membrane oxygenation (ECMO) at study entry
- •\- Current diagnosis of active malignancy that, in the opinion of the investigator, could constitute a risk when taking investigational product
- •\- Have any history of venous thromboembolism (VTE) (deep vein thrombosis \[DVT] and/or pulmonary embolism \[PE]) or are considered at high risk of VTE (DVT/PE) by the investigator
- •\- Anticipated discharge from the hospital, or transfer to another hospital (or another unit), which is not a study site within 72 hours after study entry
- •\- Have neutropenia (absolute neutrophil count \< 1000 cells/microliters)
Outcomes
Primary Outcomes
Not specified
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