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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05074420
Collaborator
(none)
24
Enrollment
22
Locations
1
Arm
10.5
Anticipated Duration (Months)
1.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Oct 15, 2021
Anticipated Primary Completion Date :
Jul 4, 2022
Anticipated Study Completion Date :
Aug 30, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Baricitinib

Baricitinib given orally to participants daily

Drug: Baricitinib
Given Orally
Other Names:
  • LY3009104
  • Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK): Area Under Concentration Curve (AUC) of Baricitinib [Day 1 and Day 4]

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

    2. PK: Maximum Concentration (Cmax) of Baricitinib [Day 1 and Day 4]

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

    Secondary Outcome Measures

    1. 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 require noninvasive ventilation/high-flow oxygen or invasive mechanical ventilation (including ECMO)

    2. 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 who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (including ECMO)

    3. 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]

      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).

    4. Number of Ventilator-Free Days [Day 1 to Day 28]

      Number of Ventilator-Free Days

    5. Time to Recovery [Day 1 to Day 28]

      Recovery assessed by the NIAID-OS

    6. Overall improvement on the NIAID-OS [Day 4, Day 7, Day 10, Day 14, and Day 28]

      Overall improvement on the NIAID-OS

    7. Duration of Hospitalization [Day 1 to Day 28]

      Duration of Hospitalization

    8. All-Cause Mortality [Day 1 to Day 28 and Day 60]

      All-Cause Mortality

    9. Duration of Stay in the Intensive Care Unit (ICU) in Days [Day 1 to Day 28]

      Duration of Stay in the ICU in Days

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    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 unnacceptable risk of immunosuppression.

    Note: A washout period is required prior to screening.

    • Are receiving strong inhibitors of Oranic 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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Arnold Palmer Hospital for ChildrenOrlandoFloridaUnited States32806
    2University Hospitals Cleveland Medical CenterClevelandOhioUnited States44106
    3University of Texas Medical BranchGalvestonTexasUnited States77555
    4MultiCare Health SystemTacomaWashingtonUnited States98405
    5Centre Hospitalier Regional de la CitadelleLiègeBelgium4000
    6Hospital de Clinicas de Porto AlegrePorto AlegreRio Grande Do SulBrazil90035-903
    7Centro de Pesquisa Sao LucasCampinasSão PauloBrazil13034-685
    8Instituto de Pesquisa clinica de CampinasCampinasSão PauloBrazil13060-080
    9CECIP - Centro de Estudos do Interior PaulistaJaúSão PauloBrazil17201130
    10Pesquisare SaudeSanto AndréSão PauloBrazil09080-110
    11Instituto de Pesquisa PENSISao PauloSão PauloBrazil01227-200
    12Government Medical College And Hospital - NagpurNagpurMaharashtraIndia440003
    13Grant Medical Foundation - Ruby Hall ClinicPuneMaharashtraIndia411001
    14Kanchi Kamakoti Childs Trust HospitalChennaiTamil NaduIndia600034
    15Instituto Nacional de PediatriaMexico CityDistrito FederalMexico04530
    16Hospital Infantil de Mexico Federico GomezMexico CityDistrito FederalMexico06720
    17Hospital Universitario Dr. José Eleuterio González, Universidad Autónoma de Nuevo LeónMonterreyNuevo LeónMexico66460
    18Complejo Hospitalario de NavarraPamplonaNavarraSpain31009
    19Hospital Clinico San CarlosMadridSpain28040
    20Hospital Universitario 12 de OctubreMadridSpain28041
    21Hospital Universitario La PazMadridSpain28046
    22Hospital Universitario de Araba (HUA)- Hospital TxagorritxuVitoria-GasteizSpain01009

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05074420
    Other Study ID Numbers:
    • 18253
    • I4V-MC-KHAB
    • 2021-001338-21
    First Posted:
    Oct 12, 2021
    Last Update Posted:
    Oct 20, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eli Lilly and Company
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 20, 2021