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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05074420
Collaborator
(none)
24
Enrollment
23
Locations
1
Arm
20.3
Anticipated Duration (Months)
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 Disease Intervention/Treatment Phase
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
Actual Study Start Date :
Dec 21, 2021
Anticipated Primary Completion Date :
Jul 14, 2023
Anticipated Study Completion Date :
Aug 30, 2023

Arms and Interventions

Arm Intervention/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:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arnold Palmer Hospital for Children Orlando Florida United States 32806
    2 St. Luke's Boise Medical Center Boise Idaho United States 83712
    3 Children's Hospital of Michigan Detroit Michigan United States 48201
    4 The University of Mississippi Medical Center Jackson Mississippi United States 39216
    5 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106
    6 University of Texas Medical Branch Galveston Texas United States 77555
    7 University of Virginia Health System Charlottesville Virginia United States 22903
    8 MultiCare Health System Tacoma Washington United States 98405
    9 Centre Hospitalier Regional de la Citadelle Liège Belgium 4000
    10 Hospital de Clinicas de Porto Alegre Porto Alegre Rio Grande Do Sul Brazil 90035-903
    11 Centro de Pesquisa Sao Lucas Campinas São Paulo Brazil 13034-685
    12 Instituto de Pesquisa clinica de Campinas Campinas São Paulo Brazil 13060-080
    13 CECIP - Centro de Estudos do Interior Paulista Jaú São Paulo Brazil 17201130
    14 Pesquisare Saude Santo André São Paulo Brazil 09080-110
    15 Instituto de Pesquisa PENSI Sao Paulo São Paulo Brazil 01227-200
    16 Instituto Nacional de Pediatria Mexico City Distrito Federal Mexico 04530
    17 Hospital Infantil de Mexico Federico Gomez Mexico City Distrito Federal Mexico 6720
    18 Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey Nuevo León Mexico 66460
    19 Complejo Hospitalario de Navarra Pamplona Navarra Spain 31009
    20 Hospital Clinico San Carlos Madrid Spain 28040
    21 Hospital Universitario 12 de Octubre Madrid Spain 28041
    22 Hospital Universitario La Paz Madrid Spain 28046
    23 Hospital Universitario de Araba (HUA)- Hospital Txagorritxu Vitoria-Gasteiz Spain 01009

    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

    Additional 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:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    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
    coronavirus
    Additional relevant MeSH terms:
    COVID-19
    Coronavirus Infections

    Study Results

    No Results Posted as of Aug 19, 2022