A Study of Baricitinib (LY3009104) in Children With COVID-19
- Registration Number
- NCT05074420
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Baricitinib Baricitinib Baricitinib given orally to participants daily
- Primary Outcome Measures
Name Time Method 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
Name Time Method Duration of Stay in the Intensive Care Unit (ICU) in Days Day 1 to Day 28 Duration of Stay in the ICU in Days
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 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).
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 All-Cause Mortality
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)
Number of Ventilator-Free Days Day 1 to Day 28 Number of Ventilator-Free Days
Trial Locations
- Locations (14)
Arnold Palmer Hospital for Children
🇺🇸Orlando, Florida, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
Centro de Pesquisa Sao Lucas
🇧🇷Campinas, São Paulo, Brazil
Instituto de Pesquisa clinica de Campinas
🇧🇷Campinas, São Paulo, Brazil
Pesquisare Saude
🇧🇷Santo André, São Paulo, Brazil
Instituto Nacional de Pediatria
🇲🇽Mexico City, Distrito Federal, Mexico
Hospital de Clinicas de Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
CECIP - Centro de Estudos do Interior Paulista
🇧🇷Jau, São Paulo, Brazil
Hospital Infantil de Mexico Federico Gomez
🇲🇽Mexico City, Mexico
Hospital Universitario de Araba (HUA)- Hospital Txagorritxu
🇪🇸Vitoria-Gasteiz, Araba, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Madrid, Comunidad De, Spain
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain