A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19

Study Overview
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Brief Summary
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The 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.

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Drug: LY3819253
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3819253<br>Participants received single doses of 700 milligrams (mg), 2800 mg or 7000 mg LY3819253 administered as intravenous infusion. | Drug: LY3819253<br>* Administered IV.<br>* Other names: Bamlanivimab;|
| Placebo Comparator: Placebo<br>Participants received single dose of Placebo as intravenous infusion. | Drug: Placebo<br>* Administered IV.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 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. | Baseline through Day 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29 | Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29. | Day 29 | 
| Pharmacodynamics (PD): Change From Baseline to Day 29 in Viral Load | Pharmacodynamics (PD): Change from Baseline to Day 29 in Viral Load. | Baseline, Day 29 | 
| Pharmacodynamics (PD): SARS-CoV-2 Viral Load AUC | 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. | Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose | 
| Pharmacodynamics (PD): Time to SARS-CoV-2 Clearance | Pharmacodynamics (PD): Time to SARS-CoV-2 clearance. | Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose |