Phase 1
Completed N=26
A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19
Source: ClinicalTrials.gov NCT04411628 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcomePrimary: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration — 0; 0; 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |
0; 0; 0; 0 | — |
| SECONDARY Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29 |
28.2; 59.4; 261 | — |
| SECONDARY Pharmacodynamics (PD): Change From Baseline to Day 29 in Viral Load |
10.476; 10.923; 16.956; 15.726 | — |
| SECONDARY Pharmacodynamics (PD): SARS-CoV-2 Viral Load AUC |
48.865; 44.858; 60.818; 69.528 | — |
| SECONDARY Pharmacodynamics (PD): Time to SARS-CoV-2 Clearance |
NA; 7.7; NA; 15.7 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04411628). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.