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

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

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.

Study Overview

• Status: Terminated
• Conditions: Covid19; Corona Virus Infection
• Intervention / Treatment: Drug: Baricitinib

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Campinas, Brazil, 13060-080
    • Instituto de Pesquisa clinica de Campinas
  • Campinas, Brazil, 13034-685
    • Centro de Pesquisa Sao Lucas
  • Jaú, Brazil, 17201130
    • CECIP - Centro de Estudos do Interior Paulista
  • Porto Alegre, Brazil, 90410000
    • Hospital de Clinicas de Porto Alegre
  • Santo André, Brazil, 09080-110
    • Pesquisare Saude
• Mexico
  • Mexico City, Mexico, 04530
    • Instituto Nacional de Pediatría
  • Mexico City, Mexico, 06720
    • Hospital Infantil de Mexico Federico Gomez
• Spain
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Pamplona, Spain, 31009
    • Complejo Hospitalario de Navarra
  • Vitoria-Gasteiz, Spain, 01009
    • Hospital Universitario de Araba (HUA)- Hospital Txagorritxu
• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • Arnold Palmer Hospital for Children
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Children's Hospital of Michigan
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.
• 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.
• Are currently enrolled in any other clinical study involving an investigation product or any other type of medical research judged not to be scientifically or medically compatible with this study. Note: The participant should not be enrolled (started) in another clinical trial for the treatment of COVID-19 or SARS CoV-2 through Day 28.
• Are pregnant, or intend to become pregnant or breastfeed during the study.
• Are, in the opinion of the investigator or sponsor, at risk of immunosuppression or otherwise unsuitable for inclusion in the study.
• Are using or will use extracorporeal blood purification (EBP) device to remove proinflammatory cytokines from the blood such as a cytokine absorption or filtering device, for example, CytoSorb®.
• Are, in the opinion of the investigator, unlikely to survive for at least 48 hours after screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baricitinib; Baricitinib given orally to participants daily	Drug: Baricitinib; Given Orally; Other Names: LY3009104

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Require Noninvasive Ventilation/high-flow oxygen or Invasive Mechanical Ventilation (including extracorporeal membrane oxygenation [ECMO])	Percentage of participants who require noninvasive ventilation/high-flow oxygen or invasive mechanical ventilation (including 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)	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	Percentage of Participants with at Least 1-Point Improvement on NIAID-OS or Live Discharge from Hospital. The NIAID-OS scale ranges from 1 - 8 (worse outcome).	Day 4, Day 7, Day 10, Day 14, and Day 28
Number of Ventilator-Free Days	Number of Ventilator-Free Days	Day 1 to Day 28
Time to Recovery	Recovery assessed by the NIAID-OS	Day 1 to Day 28
Overall improvement on the NIAID-OS	Overall improvement on the NIAID-OS	Day 4, Day 7, Day 10, Day 14, and Day 28
Duration of Hospitalization	Duration of Hospitalization	Day 1 to Day 28
All-Cause Mortality	All-Cause Mortality	Day 1 to Day 28 and Day 60
Duration of Stay in the Intensive Care Unit (ICU) in Days	Duration of Stay in the ICU in Days	Day 1 to Day 28

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2021
• Primary Completion (Actual): September 5, 2024
• Study Completion (Actual): November 4, 2024

Study Registration Dates

• First Submitted: October 8, 2021
• First Submitted That Met QC Criteria: October 8, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: coronavirus
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronaviridae Infections; Nidovirales Infections; COVID-19; Coronavirus Infections; baricitinib
• Other Study ID Numbers: 18253; I4V-MC-KHAB (Other Identifier: Eli Lilly and Company); 2021-001338-21 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing 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.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No