Title
A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19
A Randomized, Placebo-Controlled, Double-Blind, Sponsor Unblinded, Single Ascending Dose, Phase 1 First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous LY3819253 in Participants Hospitalized for COVID-19
Phase
Phase 1Lead Sponsor
Eli LillyStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
COVID-19Intervention/Treatment
LY3819253 ...Study Participants
26The purpose of this study is to test the safety and tolerability of LY3819253 when it is given by injection into a vein to participants hospitalized with COVID-19. Blood tests will be done to check how much LY3819253 is in the bloodstream and how long the body takes to eliminate it. Participation could last about 8 weeks and may include up to 15 visits in the hospital or the home.
Administered IV.
Inclusion Criteria: Are hospitalized or in the process of being admitted to hospital and have an initial laboratory determination of current COVID-19 infection less than or equal to (≤)72 hours prior to randomization Are men or non-pregnant women Women of childbearing potential must agree to use at least one highly effective form of contraception for the entirety of the study Agree to the collection of nasopharyngeal swabs and venous blood Exclusion Criteria: Require mechanical ventilation or anticipated impending need for mechanical ventilation Received convalescent COVID-19 plasma treatment prior to enrollment Were resident in a nursing home or long-term care facility immediately prior to current hospitalization 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 investigational product Have an oxygen saturation (SpO2) less than (<)88 percent (%) while breathing room air at rest at randomization.
| Event Type | Organ System | Event Term | Placebo | 700 mg LY3819253 IV | 2800 mg LY3819253 IV | 7000 mg LY3819253 IV |
|---|
An SAE is any adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.
Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29.
Pharmacodynamics (PD): Change from Baseline to Day 29 in Viral Load.
The SARS-CoV-2 viral load was derived from the cycle time (CT) values using a polymerase chain reaction (PCR) assay. Higher CT values indicate a lower viral load.
Pharmacodynamics (PD): Time to SARS-CoV-2 clearance.
