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

Covid19 Clinical Trial

— COV-BARRIER  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05074420
• Other study ID #: 18253
• Secondary ID: I4V-MC-KHAB2021-
• Status: Recruiting
• Phase: Phase 3
• Start date: December 21, 2021
• Est. completion date: August 30, 2024

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: August 30, 2024
• Est. primary completion date: July 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Covid19

Intervention

Drug:
• Baricitinib
Given Orally

Locations

Country	Name	City	State
Belgium	Centre Hospitalier Régional de la Citadelle	Liège
Brazil	Centro de Pesquisa Sao Lucas	Campinas	São Paulo
Brazil	CECIP - Centro de Estudos do Interior Paulista	Jau	São Paulo
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Pesquisare Saude	Santo André	São Paulo
Mexico	Hospital Infantil de Mexico Federico Gomez	Mexico City
Mexico	Instituto Nacional de Pediatria	Mexico City	Distrito Federal
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario La Paz	Madrid	Madrid, Comunidad De
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Hospital Universitario de Araba (HUA)- Hospital Txagorritxu	Vitoria-Gasteiz	Araba
United States	University of Virginia Health System	Charlottesville	Virginia
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Children's Hospital of Michigan	Detroit	Michigan
United States	University of Texas Medical Branch	Galveston	Texas
United States	The University of Mississippi Medical Center	Jackson	Mississippi
United States	Arnold Palmer Hospital for Children	Orlando	Florida
United States	MultiCare Health System	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Mexico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Area Under Concentration Curve (AUC) of Baricitinib	PK: AUC of Baricitinib in pediatric participants with COVID-19	Day 1 and Day 4
Primary	PK: Maximum Concentration (Cmax) of Baricitinib	PK: Cmax of Baricitinib in pediatric participants with COVID-19	Day 1 and Day 4
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Ventilator-Free Days	Number of Ventilator-Free Days	Day 1 to Day 28
Secondary	Time to Recovery	Recovery assessed by the NIAID-OS	Day 1 to Day 28
Secondary	Overall improvement on the NIAID-OS	Overall improvement on the NIAID-OS	Day 4, Day 7, Day 10, Day 14, and Day 28
Secondary	Duration of Hospitalization	Duration of Hospitalization	Day 1 to Day 28
Secondary	All-Cause Mortality	All-Cause Mortality	Day 1 to Day 28 and Day 60
Secondary	Duration of Stay in the Intensive Care Unit (ICU) in Days	Duration of Stay in the ICU in Days	Day 1 to Day 28

External Links

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