Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
The purpose of this study is to measure how well LY3819253 and LY3832479 work against the virus that causes COVID-19. LY3819253 and LY3832479 will be given to participants with early symptoms of COVID-19. Samples will be taken from the back of the nose to determine how much virus is in the body at various times during the study. Participation could last about 12 weeks and includes one required visit to the study site, with the remainder of assessments performed in the home or by phone.
Pediatric participants, with mild to moderate COVID-19 illness, will enroll in a single-arm (Arm 22), open-label addendum to evaluate the pharmacokinetics and safety of LY3819253 and LY3832479. Enrollment began on March 31, 2021, and completed on September 24, 2021.
Pediatric participants, with mild to moderate COVID-19 illness, will enroll in a single-arm (Arm 23), open-label addendum to evaluate the pharmacokinetics and safety of LY3853113. Enrollment began on August 19, 2022, and completed on February 21, 2023.
Enrollment
Sex
Volunteers
Inclusion criteria
Participants in treatment arms 7-9, 13-14, and 18-21 ONLY
Are greater than or equal to (≥)18 years of age and must satisfy at least one of the following at the time of screening
Are pregnant
Are ≥65 years of age
Have a body mass index (BMI) ≥35
Have chronic kidney disease (CKD)
Have type 1 or type 2 diabetes
Have immunosuppressive disease
Are currently receiving immunosuppressive treatment or
Are ≥55 years of age AND have:
Are 12-17 years of age (inclusive) AND satisfy at least one of the following at the time of screening
Participants in treatment arm 22 ONLY
Are pregnant
Have a BMI ≥85th percentile for their age and gender based on CDC growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm
Have sickle cell disease
Have congenital or acquired heart disease
Have neurodevelopmental disorders, for example, cerebral palsy, autism, or Down syndrome (FAIR Health 2020; Spreat et al. 2020)
Have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)
Have asthma, cystic fibrosis, reactive airways disease or other chronic respiratory disease that requires daily medication for control
Have type 1 or type 2 diabetes
Have chronic kidney disease
Have immunosuppressive disease, or
Are currently receiving immunosuppressive treatment, or
Are less than (<) one year of age.
Have one or more COVID-19 symptoms
Participants in treatment arm 23 ONLY:
Must have first positive result sample of current SARS-CoV-2 viral infection ≤3 days prior to start of treatment administration.
Participant can have COVID previously and still meet criteria for this addendum. Positive result needs to be from a current infection.
Are 0 (≥ 38 weeks gestational age and ≥ 3.3 kg) to <12 years of age at the time of screening, or are 12 to 17 and weighing <40 kg; and
Exclusion criteria
Participants in Treatment Arm 22 ONLY
Participants in treatment arm 23 ONLY
Primary purpose
Allocation
Interventional model
Masking
3,307 participants in 5 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal