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 | NYU Langone Health

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Conditions:
Coronavirus Infection
Age: Between 18 years - 75 years
Gender: Male or Female

Other Inclusion Criteria:
1. Participants have at least moderate COVID-19 illness as defined by the NIH which is the moderate – evidence of lower respiratory disease by clinical assessment or imaging and SpO2>93% on room air.
2. Participants who have at least one of the following:
  - fever
  - cough
  - sore throat
  - loss of taste or smell
  - malaise
  - headache
  - muscle pain
  - shortness of breath at rest or with exertion with or without confusion, or
  - symptoms of severe lower respiratory symptoms including dyspnea at rest or respiratory distress.
3. Participants who are hospitalized, or in the process of being admitted to hospital, and have an initial laboratory determination of current COVID-19 infection =72 hours prior to randomization
4. Participants who understand and agree to comply with planned study procedures
5. Participants or their legally authorized representative who can provide written informed consent

You may not be eligible for this study if the following are true:

1. Participants who require mechanical ventilation or anticipated impending need for mechanical ventilation
2. Participants anticipating transfer to another hospital which is not a study site within 5 days of randomization
3. Those with known allergies to any of the components used in the formulation of the interventions
4. Participants who have hemodynamic instability requiring use of pressors within 24 hours of randomization
5. Participants who were resident in a nursing home or long-term care facility immediately prior to current hospitalization
6. Suspected or proven serious, active bacterial, fungal, viral, or other infection
7. Have any co-morbidity requiring surgery within <7 days, or that is considered life- threatening within 29 days
8. Have prior history of hepatic impairment, such as
  - severe liver cirrhosis Child-Pugh B or worse
  - cirrhosis with a history of hepatic encephalopathy
  - clinically meaningful ascites requiring ongoing treatment with diuretics and/or paracentesis, or
  - history of hepatorenal syndrome.
9. Participants who have any serious concomitant systemic disorder
10. Participants diagnosed with active malignancy
11. Those who received convalescent COVID-19 plasma treatment prior to enrollment
12. Participants who are pregnant or breast feeding