A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness
A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness
The purpose of this study is to measure how well LY3819253, alone or in combination with
 either LY3832479 (LY-CoV016) or VIR-7831, works against the virus that causes COVID-19. Study
 drug(s) will be given to participants with early symptoms of COVID-19. 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 or 24 weeks and includes at least 1 visit to the
 study site, with the remainder of assessments performed in the home, local clinic, or by
 phone.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  Body mass index (BMI) greater than or equal to (≥)35

 -  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 ≥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 or have received a SARS-CoV-2
 vaccine

 -  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

 -  Are investigator site personnel directly affiliated with this study