A Study of Baricitinib (LY3009104) in Children With COVID-19 (COV-BARRIER-PEDS)
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.
Arms and Interventions
Baricitinib given orally to participants daily
Primary Outcome Measures
- Pharmacokinetics (PK): Area Under Concentration Curve (AUC) of Baricitinib [Day 1 and Day 4]
PK: AUC of Baricitinib in pediatric participants with COVID-19
- PK: Maximum Concentration (Cmax) of Baricitinib [Day 1 and Day 4]
PK: Cmax of Baricitinib in pediatric participants with COVID-19
Secondary Outcome Measures
- 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)
- 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)
- 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).
- Number of Ventilator-Free Days [Day 1 to Day 28]
Number of Ventilator-Free Days
- Time to Recovery [Day 1 to Day 28]
Recovery assessed by the NIAID-OS
- Overall improvement on the NIAID-OS [Day 4, Day 7, Day 10, Day 14, and Day 28]
Overall improvement on the NIAID-OS
- Duration of Hospitalization [Day 1 to Day 28]
Duration of Hospitalization
- All-Cause Mortality [Day 1 to Day 28 and Day 60]
- Duration of Stay in the Intensive Care Unit (ICU) in Days [Day 1 to Day 28]
Duration of Stay in the ICU in Days
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.
- 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
|1||Arnold Palmer Hospital for Children||Orlando||Florida||United States||32806|
|2||University Hospitals Cleveland Medical Center||Cleveland||Ohio||United States||44106|
|3||University of Texas Medical Branch||Galveston||Texas||United States||77555|
|4||MultiCare Health System||Tacoma||Washington||United States||98405|
|5||Centre Hospitalier Regional de la Citadelle||Liège||Belgium||4000|
|6||Hospital de Clinicas de Porto Alegre||Porto Alegre||Rio Grande Do Sul||Brazil||90035-903|
|7||Centro de Pesquisa Sao Lucas||Campinas||São Paulo||Brazil||13034-685|
|8||Instituto de Pesquisa clinica de Campinas||Campinas||São Paulo||Brazil||13060-080|
|9||CECIP - Centro de Estudos do Interior Paulista||Jaú||São Paulo||Brazil||17201130|
|10||Pesquisare Saude||Santo André||São Paulo||Brazil||09080-110|
|11||Instituto de Pesquisa PENSI||Sao Paulo||São Paulo||Brazil||01227-200|
|12||Government Medical College And Hospital - Nagpur||Nagpur||Maharashtra||India||440003|
|13||Grant Medical Foundation - Ruby Hall Clinic||Pune||Maharashtra||India||411001|
|14||Kanchi Kamakoti Childs Trust Hospital||Chennai||Tamil Nadu||India||600034|
|15||Instituto Nacional de Pediatria||Mexico City||Distrito Federal||Mexico||04530|
|16||Hospital Infantil de Mexico Federico Gomez||Mexico City||Distrito Federal||Mexico||06720|
|17||Hospital Universitario Dr. José Eleuterio González, Universidad Autónoma de Nuevo León||Monterrey||Nuevo León||Mexico||66460|
|18||Complejo Hospitalario de Navarra||Pamplona||Navarra||Spain||31009|
|19||Hospital Clinico San Carlos||Madrid||Spain||28040|
|20||Hospital Universitario 12 de Octubre||Madrid||Spain||28041|
|21||Hospital Universitario La Paz||Madrid||Spain||28046|
|22||Hospital Universitario de Araba (HUA)- Hospital Txagorritxu||Vitoria-Gasteiz||Spain||01009|
Sponsors and Collaborators
- Eli Lilly and Company
- 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.