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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LY3819253 		Participants received single doses of 700 milligrams (mg), 2800 mg or 7000 mg LY3819253 administered as intravenous infusion.
  • Drug: LY3819253
    Administered IV.
    Other names:
    • LY-CoV555
    • Bamlanivimab
Placebo Comparator
Placebo 		Participants received single dose of Placebo as intravenous infusion.
  • Drug: Placebo
    Administered IV.

Recruiting Locations

More Details

NCT ID
NCT04411628
Status
Completed
Sponsor
Eli Lilly and Company

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.