Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UCSD
Dates
study started
estimated completion
Principal Investigator
Mary K Lewinski (ucsd)
Photo of Mary K Lewinski
Mary K Lewinski

Description

Summary

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

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

Keywords

COVID-19

Eligibility

You can join if…

Open to people ages 18-75

  • 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

You CAN'T join if...

  • 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.

Locations

  • Veterans Affairs Medical Center San Diego not yet accepting patients
    San Diego California 92161 United States
  • Cedars Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States

Lead Scientist at UC Health

  • Mary K Lewinski (ucsd)
    Assistant Adjunct Professor, Medicine. Authored (or co-authored) 15 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
Related Info
ID
NCT04411628
Phase
Phase 1
Study Type
Interventional
Last Updated