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

NCT05074420 | Terminated Phase 3 DMC FDA Drug

• 3 other identifiers: 18253I4V-MC-KHAB2021-001338-21
• Study Type: interventional
• Target: 6
• Locations: 4 countries
• Sites: 14

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.

Conditions

Covid19; Corona Virus Infection

Keywords

coronavirus

Outcome Measures

Primary Outcomes (2)

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

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

  Day 1 and Day 4

• PK: Maximum Concentration (Cmax) of Baricitinib

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

  Day 1 and Day 4

Secondary Outcomes (9)

• Percentage of Participants Who Require Noninvasive Ventilation/high-flow oxygen or Invasive Mechanical Ventilation (including extracorporeal membrane oxygenation [ECMO])

  Day 1 to Day 28

• Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (including ECMO)

  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

• Number of Ventilator-Free Days

  Day 1 to Day 28

• Time to Recovery

  Day 1 to Day 28

Study Arms (1)

Baricitinib

EXPERIMENTAL

Baricitinib given orally to participants daily

Drug: Baricitinib

Interventions

Baricitinib DRUG

Given Orally

Also known as: LY3009104

Baricitinib

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Have neutropenia (absolute neutrophil count \<1000 cells/microliters).
• Have lymphopenia (absolute lymphocyte count \<200 cells/microliters).
• Have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>5 times AAULN.
• Estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease \[MDRD\]) \<40 milliliter/minute/1.73 meters squared.
• Have a known hypersensitivity to baricitinib or any of its excipients.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (14)

Arnold Palmer Hospital for Children

Orlando, Florida, 32806, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Centro de Pesquisa Sao Lucas

Campinas, 13034-685, Brazil

Location

Instituto de Pesquisa clinica de Campinas

Campinas, 13060-080, Brazil

Location

CECIP - Centro de Estudos do Interior Paulista

Jaú, 17201130, Brazil

Location

Hospital de Clinicas de Porto Alegre

Porto Alegre, 90410000, Brazil

Location

Pesquisare Saude

Santo André, 09080-110, Brazil

Location

Instituto Nacional de Pediatria

Mexico City, 04530, Mexico

Location

Hospital Infantil de Mexico Federico Gomez

Mexico City, 06720, Mexico

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, 31009, Spain

Location

Hospital Universitario de Araba (HUA)- Hospital Txagorritxu

Vitoria-Gasteiz, 01009, Spain

Location

Related Links

• A Study of Baricitinib (LY3009104) in Children With COVID-19 (COV-BARRIER-PEDS)

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

baricitinib

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 12, 2021
• Study Start: December 21, 2021
• Primary Completion: September 5, 2024
• Study Completion: November 4, 2024
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

BR (5); ME (2); US (3); ES (4)