Clinical trial NCT05074420: A Study of Baricitinib (LY3009104) in Children With COVID-19
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Covid19
Corona Virus Infection
Keywords: coronavirus
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-10-12
Enrollment: 24
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under Concentration Curve (AUC) of Baricitinib
timeFrame: Day 1 and Day 4
measure: PK: Maximum Concentration (Cmax) of Baricitinib
timeFrame: Day 1 and Day 4
Secondary outcomes:
measure: Percentage of Participants Who Require Noninvasive Ventilation/high-flow oxygen or Invasive Mechanical Ventilation (including extracorporeal membrane oxygenation [ECMO])
timeFrame: Day 1 to Day 28
measure: Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (including ECMO)
timeFrame: Day 1 to Day 28
measure: 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
timeFrame: Day 4, Day 7, Day 10, Day 14, and Day 28
measure: Number of Ventilator-Free Days
timeFrame: Day 1 to Day 28
measure: Time to Recovery
timeFrame: Day 1 to Day 28
measure: Overall improvement on the NIAID-OS
timeFrame: Day 4, Day 7, Day 10, Day 14, and Day 28
measure: Duration of Hospitalization
timeFrame: Day 1 to Day 28
measure: All-Cause Mortality
timeFrame: Day 1 to Day 28 and Day 60
measure: Duration of Stay in the Intensive Care Unit (ICU) in Days
timeFrame: Day 1 to Day 28
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Arnold Palmer Hospital for Children
state: Florida
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
city: Campinas
country: Brazil
facility: Centro de Pesquisa Sao Lucas
state: São Paulo
city: Campinas
country: Brazil
facility: Instituto de Pesquisa clinica de Campinas
state: São Paulo
city: Jau
country: Brazil
facility: CECIP - Centro de Estudos do Interior Paulista
state: São Paulo
city: Santo André
country: Brazil
facility: Pesquisare Saude
state: São Paulo
city: Mexico City
country: Mexico
facility: Instituto Nacional de Pediatria
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Hospital Infantil de Mexico Federico Gomez
city: Vitoria-Gasteiz
country: Spain
facility: Hospital Universitario de Araba (HUA)- Hospital Txagorritxu
state: Araba
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
state: Madrid, Comunidad De
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: