The purpose for this study is to determine if the study drug baricitinib is effective andsafe in hospitalized pediatric participants with Coronavirus disease 2019 (COVID -19) andto confirm the dose.
Not Provided
Drug: Baricitinib
Given Orally
Other Name: LY3009104
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.
Arnold Palmer Hospital for Children
Orlando, Florida, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
The University of Mississippi Medical Center
Jackson, Mississippi, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
MultiCare Health System
Tacoma, Washington, United States
Centre Hospitalier Régional de la Citadelle
Liège, Belgium
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande Do Sul, Brazil
Centro de Pesquisa Sao Lucas
Campinas, São Paulo, Brazil
Instituto de Pesquisa clinica de Campinas
Campinas, São Paulo, Brazil
CECIP - Centro de Estudos do Interior Paulista
Jau, São Paulo, Brazil
Pesquisare Saude
Santo André, São Paulo, Brazil
Instituto Nacional de Pediatria
Mexico City, Distrito Federal, Mexico
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 Clinico San Carlos
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
clinical_inquiry_hub@lilly.com
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), Study Director
Eli Lilly and Company