A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT04427501

Run by

Eli Lilly and Company

People needed

3307

Starts

2020-06-17

Expected to finish

2023-02-21

Last updated by the study team

2024-04-11

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Are currently not hospitalized. (Not applicable to participants in treatment arm 22.)
• Have one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion. (Not applicable to participants in treatment arm 22.)
• Must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion
• Are males or females, including pregnant females who agree to contraceptive requirements
• Understand and agree to comply with planned study procedures
• Agree to the collection of nasopharyngeal swabs and venous blood. (Not applicable to participants in treatment arms 20-21.)
• The participant or legally authorized representative give signed informed consent and/or assent
• 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:
• cardiovascular disease (CVD), OR
• hypertension, OR
• chronic obstructive pulmonary disease (COPD) or other chronic respiratory disease
• Are 12-17 years of age (inclusive) AND satisfy at least one of the following at the time of screening
• Are pregnant
• Have a body mass index (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

You may not qualify if…

• Have oxygen saturation (SpO2) less than or equal to (≤)93 percent (%) on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) less than (<)300, respiratory rate greater than or equal to (≥)30 per minute, heart rate ≥125 per minute due to COVID-19
• Require mechanical ventilation or anticipated impending need for mechanical ventilation due to COVID-19
• Have known allergies to any of the components used in the formulation of the interventions
• Have hemodynamic instability requiring use of pressors within 24 hours of randomization
• Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention
• Have any co-morbidity requiring surgery within <7 days, or that is considered life-threatening within 29 days
• Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study
• Have a history of a positive SARS-CoV-2 test prior to the one serving as eligibility for this study
• Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing
• Have received treatment with a SARS-CoV-2 specific monoclonal antibody
• Have received convalescent COVID-19 plasma treatment
• Have participated in a previous SARS-CoV-2 vaccine study or have received a SARS-CoV-2 vaccine
• Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed
• Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
• Mothers who are breast feeding
• Participants in Treatment Arm 22 ONLY
• Have a diagnosis of Multisystem Inflammatory Syndrome in Children (MIS-C) in the opinion of the investigator
• Are currently hospitalized for treatment of COVID-19. Other reasons for hospitalization are acceptable.
• Participants in treatment arm 23 ONLY
• SpO2 ≤ 93% on room air at sea level, or while on chronic oxygen therapy and/or respiratory support due to underlying non-COVID-19 related comorbidity, respiratory rate ≥30 per minute, and heart rate ≥125 per minute due to COVID-19 (FDA February 2021)
• Require mechanical ventilation or anticipated impending need for mechanical ventilation due to COVID-19
• Have known allergies to any of the components used in the formulation of the interventions
• Have hemodynamic instability requiring use of pressors within 24 hours of randomization
• Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention
• Have any co-morbidity requiring surgery within 7 days, or that is considered life-threatening within 29 days

Where it is running

• Clinnova Research - Redondo Beach — Redondo Beach, California, United States
• Bio-Medical Research, LLC — Miami, Florida, United States
• Rophe Adult and Pediatric Medicine — Union City, Georgia, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• U of MA Mem Med Ctr — Worcester, Massachusetts, United States
• Great Lakes Research Group, Inc. — Bay City, Michigan, United States
• Childrens Hospital of Michigan — Detroit, Michigan, United States
• Sky Clinical Prime and Health Wellness Clinic — Fayette, Mississippi, United States
• Sky Clin Resch - Quinn HC — Ridgeland, Mississippi, United States
• Monroe Biomed Research — Monroe, North Carolina, United States
• B S & W Med Center — Dallas, Texas, United States
• Sun Research Institute — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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