Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
estimated completion
Principal Investigator
by Donald Forthal (uci)

Description

Summary

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, via an injection into a vein. 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.

Official Title

A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of LY3819253 and LY3832479 in Participants With Mild to Moderate COVID-19 Illness

Keywords

COVID-19

Eligibility

You can join if…

Open to people ages 18 years and up

  • Are currently not hospitalized
  • 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
  • Must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion
  • Are men or non-pregnant women who agree to contraceptive requirements
  • Understand and agree to comply with planned study procedures
  • Agree to the collection of nasopharyngeal swabs and venous blood
  • The participant or legally authorized representative give signed informed consent
  • Treatment arms 7 and 8 only: Participants are greater than or equal to (≥) 65 years of age at the time of randomization OR have a body mass index (BMI) ≥ 35 OR are ≥ 55 years of age and have a BMI ≥ 30 and have a history of myocardial infarction or stroke

You CAN'T join 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
  • Require mechanical ventilation or anticipated impending need for mechanical ventilation
  • 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 a history of convalescent COVID-19 plasma treatment
  • Have participated in a previous SARS-CoV-2 vaccine study
  • 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
  • Are pregnant or breast feeding

Locations

  • University of CA, Irvine accepting new patients
    Orange California 92868 United States
  • Cedars Sinai Medical Center accepting new patients
    Los Angeles California 90048-5615 United States
  • Kaiser Permanente - SD Med Ctr accepting new patients
    San Diego California 92123 United States
  • Wolverine Clinical Trials, LLC not yet accepting patients
    Santa Ana California 92705 United States

Lead Scientist at UC Health

  • Donald Forthal (uci)
    Professor, Medicine. Authored (or co-authored) 108 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness (BLAZE-1)
ID
NCT04427501
Phase
Phase 2
Study Type
Interventional
Last Updated