Study Details

Protocol Status: Enrolling
Study Purpose:

Randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of intravenous LY3819253 in preventing SARS-CoV-2 and COVID-19, compared to placebo.

Study Design:

This is a 2-arm interventional study that is double-blinded.

Study Population:

Skilled nursing and assisted living facilities will serve as the setting to find participants with a high risk of SARS-CoV-2 exposure. Residents and facility staff may be included in this study.

Study Size:

Approximately 1700 participants (intent-to-treat [ITT] population) on average will be randomly assigned to study intervention such that approximately 1300 SARS-CoV-2 RT-PCR and serology negative participants are randomized in the study with the goal of achieving approximately 33 events (in each of the primary and key secondary endpoints) in the prevention population.

The maximum sample size for this study is approximately 2400 participants in the ITT population.

Study Duration:

The maximum total duration of study participation for each participant is 24 weeks.

Treatment Regimen:

Eligible participants will be randomized to one of two arms: placebo or LY3819253. Participants will receive one intravenous infusion of study intervention.

Primary Objectives:

4 weeks from randomization:
- Compare the incidence of SARS-CoV-2 infection

Secondary Objectives:

8 weeks from randomization:
- Compare the incidence of moderate or worse severity COVID-19
- Compare the incidence of COVID-19

Other Objectives:

8 weeks from randomization:
- Compare the incidence of SARS-CoV-2 infection
- Compare the frequency of hospitalization due to COVID-19
- Characterize clinical status for participants
- Compare the mortality due to COVID-19

Key Study Personnel

Jontraye Davis, Protocol Team Member
Jennifer Farrior, LOC Clinical Research Manager
Jonathan Lucas, Protocol Team Member
Leah Schrumpf, LOC Clinical Research Manager