A Study of Baricitinib (LY3009104) in Children With COVID-19

Part of paid clinical trials in Orlando, Florida.

Sponsor
Eli Lilly and Company
Study ID
NCT05074420
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 18 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Oct 12, 2021
Start date
Dec 21, 2021
Status verified
Jul 2026
Primary completion
Sep 5, 2024
Completion
Nov 4, 2024

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Baricitinib QD
    * Participants received baricitinib as an oral suspension (2 milligrams per milliliter \[mg/mL\]) administered once daily (QD), with age group-based dosing: 4 milligrams (mg) for participants aged 10 to \<18 years and up to 2 mg for those aged 1 to \<10 years. * Treatment was administered for up to 14 days or until hospital discharge, whichever occurred first, with follow-up assessments through approximately Day 60.

Primary Outcome Measure

Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC) of Baricitinib [ Time Frame: Day 1: 0.25, 0.5, 2-4 hours post-dose; Day 4: Pre-dose, 1, 6-10 hours post-dose ]

Locations (3)

FacilityCityStateZIPSite coordinators
Arnold Palmer Hospital for ChildrenOrlandoFlorida32806-
Children's Hospital of MichiganDetroitMichigan48201-
University Hospitals Cleveland Medical CenterClevelandOhio44106-

Find similar trials in Orlando, FL

Nationwide
COVID-19 / long COVID trialsInfectious disease trials
By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Arnold Palmer Hospital for Children· Orlando, FLChildren's Hospital of Michigan· Detroit, MIUniversity Hospitals Cleveland Medical Center· Cleveland, OH

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