COVID-19 infection MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Olumiant
Product Code: LY3009104
Pharmaceutical Form: Oral suspension
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Concentration unit: mg/ml milligram(s)/millilit
Sponsors
Lilly S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female patients from 1 to =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: - Are receiving biologic treatments (such as TNF inhibitors, interleukin inhibitors, T-cell or B-cell targeted therapies, interferons, or JAK inhibitors) for any indication at study entry; 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 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 nonlive (inactivated) vaccinations is 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 any history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) or are considered at high risk of VTE (DVT/PE) by the investigator - 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 5 times AAULN - Estimated glomerular filtration rate (eGFR) <40 milliliter/minute/1.73 meters squared
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the pharmacokinetics (PK) of baricitinib in pediatric patients with COVID-19;Secondary Objective: - To describe the safety of baricitinib in pediatric patients with COVID-19 - To describe the effect of baricitinib on COVID-19 progression in pediatric patients - To describe clinical outcomes in pediatric patients with COVID-19 treated with baricitinib;Primary end point(s): Pharmacokinetic parameters, including AUC and Cmax of baricitinib, in pediatric patients with COVID-19;Timepoint(s) of evaluation of this end point: Day 1 and day 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Safety assessments, including AEs and laboratory abnormalities 2. Proportion of patients who require noninvasive ventilation/high-flow oxygen or invasive mechanical ventilation (including ECMO) by Day 28 3. Proportion of patients who die or require noninvasive ventilation/high-flow oxygen or invasive mechanical ventilation (including ECMO) by Day 28 4. Proportion of patients with at least 1-point improvement on NIAID-OS or live discharge from hospital at Day 4, Day 7, Day 10, Day 14, and Day 28 5. Number of ventilator-free days (Day 1 to Day 28) 6. Time to recovery on the NIAID-OS (Day 1 to Day 28) 7. Overall improvement on the NIAID-OS evaluated at Day 4, Day 7, Day 10, Day 14, and Day 28 8. Duration of hospitalization (Day 1 to Day 28) 9. All-cause mortality (Day 1 to Day 28 and Day 60) 10. Duration of stay in the intensive care unit (ICU) in days (Day 1 to Day 28);Timepoint(s) of evaluation of this end point: All secondary endpoints will be evaluated (Day 1 to Day 28), except: endpoint number 9 (Day 1 to Day 28 and Day 60) | — |
Countries
Belgium, Brazil, Italy, Mexico, Netherlands, Spain, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly Cork Ltd
Outcome results
None listed