PYAB (BLAZE-1)

Condition: COVID-19

Eligibility

Key Inclusion Criteria:

  • Currently not hospitalized
  • Has one or more mild or moderate COVID-19 symptoms
  • Must have sample collection for first positive SARS-CoV-2 viral infection determination ≤3 days prior to beginning the study treatment
  • At least 18 years old and satisfies at least one of the following at the time of screening:
    •  ≥65 years old
    •  Has body mass index ≥35
    • Has chronic kidney disease
    •  Has type 1 or type 2 diabetes
    • Has immunosuppressive disease
    •  Is currently receiving immunosuppressive treatment OR
    • is ≥55 years old AND has
    • cardiovascular disease OR
    • hypertension OR
    • chronic obstructive pulmonary disease or other chronic respiratory disease

Key Exclusion Criteria:

  •  Hospitalization
  • SpO2 ≤93% on room air at sea level or PaO2/FiO2 <300, respiratory rate ≥30 per minute, heart rate ≥125 per minute
  • Has known allergies to any component used in the formulation of the interventions
     

Full Study Name:

A Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Evaluate the Efficacy and Safety of LY3819253 and LY3832479 in Participants With Mild to Moderate COVID-19 Illness (IRB no. 00000837)

Summary

The purpose of this study is to evaluate the safety and effectiveness of an investigational drug called LY3819253, alone and in combination with the drug LY3832479, in individuals with mild to moderate COVID-19. The study will also examine the dose of these drugs that should be given. Researchers will compare LY3819253 alone and in combination with LY3832479 to placebo (inactive substance). Participants will have a 1 in 2 chance of receiving either a placebo or LY dose (study drug). Because the COVID-19 pandemic may impact participants’ ability or willingness to attend onsite study visits, mobile health visits will be offered so that study procedures can be conducted at home.

Principal Investigator
Contact

Pulmonary Research Team
310-423-8474
GroupLungResearch@cshs.org