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

Eli Lilly and Company14 sites in 4 countries6 target enrollmentDecember 21, 2021

ConditionsCovid19 Corona Virus Infection

InterventionsBaricitinib

DrugsBaricitinib

Overview

Phase: Phase 3
Intervention: Baricitinib
Conditions: Covid19
Sponsor: Eli Lilly and Company
Enrollment: 6
Locations: 14
Primary Endpoint: Pharmacokinetics (PK): Area Under Concentration Curve (AUC) of Baricitinib
Status: Terminated
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 21, 2021

End Date

November 4, 2024

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•Are receiving biologic treatments (such as Tumor Necrosis Factor \[TNF\] inhibitors, interleukin inhibitors, T-cell or B-cell targeted therapies, interferon, or Janus kinase (JAK) inhibitors); 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 Organic Anion Transporter 3 (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 non-live (inactivated) vaccinations are 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 a history of venous thromboembolism (VTE) (deep vein thrombosis \[DVT\] and/or pulmonary embolism \[PE\]) or considered high risk of VTE (DVT/PE).
•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.

Arms & Interventions

Baricitinib

Baricitinib given orally to participants daily

Intervention: Baricitinib

Outcomes

Primary Outcomes

Pharmacokinetics (PK): Area Under Concentration Curve (AUC) of Baricitinib

Time Frame: Day 1 and Day 4

PK: AUC of Baricitinib in pediatric participants with COVID-19

PK: Maximum Concentration (Cmax) of Baricitinib

Time Frame: Day 1 and Day 4

PK: Cmax of Baricitinib in pediatric participants with COVID-19

Secondary Outcomes

Percentage of Participants Who Require Noninvasive Ventilation/high-flow oxygen or Invasive Mechanical Ventilation (including extracorporeal membrane oxygenation [ECMO])(Day 1 to Day 28)
Duration of Stay in the Intensive Care Unit (ICU) in Days(Day 1 to Day 28)
Percentage of Participants with at Least 1-Point Improvement on National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) or Live Discharge from Hospital(Day 4, Day 7, Day 10, Day 14, and Day 28)
Time to Recovery(Day 1 to Day 28)
Overall improvement on the NIAID-OS(Day 4, Day 7, Day 10, Day 14, and Day 28)
Duration of Hospitalization(Day 1 to Day 28)
All-Cause Mortality(Day 1 to Day 28 and Day 60)
Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (including ECMO)(Day 1 to Day 28)
Number of Ventilator-Free Days(Day 1 to Day 28)