The purpose of this study is to evaluate whether LY3819253 given alone and with LY3832479 prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease - 2019 (COVID-19). Facility staff and residents in contracted skilled nursing and assisted living facility networks with a high risk of SARS-CoV-2 exposure will receive LY3819253, LY3819253 and LY3832479, or placebo via an injection into a vein. Samples will be taken from the nose. Blood samples will be drawn. Participation could last up to 25 weeks and may include up to 19 visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,180
Administered IV.
Administered IV.
Administered IV.
Unv of AL Sch of Med Div of Infectious Diseases
Birmingham, Alabama, United States
Care Access Research
Phoenix, Arizona, United States
Allergy and Asthma Clin of NW Ark
Bentonville, Arkansas, United States
Care Access Research LLC
Huntington Beach, California, United States
Alta Bates SMC
Oakland, California, United States
University of Colorado-Anschultz Medical Campus
Aurora, Colorado, United States
NIAID
Miami, Florida, United States
NIAID
Decatur, Georgia, United States
Belmont Village Lincoln Park
Lincoln Park, Illinois, United States
Family Medicine
Indianapolis, Indiana, United States
...and 17 more locations
Percentage of Participants With COVID-19
The endpoint for the primary analysis is defined as the first occurrence of coronavirus disease - 2019 (COVID-19), defined as the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by reverse transcription - polymerase chain reaction (RT-PCR) AND mild or worse disease severity within 21 days of detection, by Day 57 (8 weeks after randomization). The participant needed to test positive on or prior to week 8, and they needed to develop their symptoms on or after their positive test date, but no later than 21 days after their positive swab OR Week 8, whichever comes first. Logistic regression model was used which includes occurrence of a primary endpoint event as the response variable, and treatment and stratification factors such as facility as explanatory variables.
Time frame: Week 8 after randomization
Percentage of Participants With Moderate or Worse Severity COVID-19
The endpoint defined as the detection of SARS-CoV-2 by polymerase chain reaction (RT-PCR) AND moderate or worse disease severity within 21 days of detection, by Day 57 (Week 8) were summarized by treatment group. The participant needed to test positive on or prior to week 8, and they needed to develop their symptoms on or after their positive test date, but no later than 21 days after their positive swab OR Week 8, whichever comes first. Logistic regression model was used which includes occurrence of a primary endpoint event as the response variable, and treatment and stratification factors such as facility as explanatory variables.
Time frame: Week 8 after randomization
Percentage of Participants With SARS-CoV-2
Percentage of Participants with SARS-CoV-2.
Time frame: Week 4
Percentage of Participants Who Are Hospitalized or Have Died Due to COVID-19
Percentage of Participants Who are Hospitalized or Have Died due to COVID-19.
Time frame: Week 8
Percentage of Participants Who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death
Percentage of Participants who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death.
Time frame: Week 8
Percentage of Participants Who Die Due to COVID-19
Percentage of Participants Who Die Due to COVID-19.
Time frame: Week 8
Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Administered Alone
Pharmacokinetics (PK): Mean Concentration of bamlanivimab Administered Alone.
Time frame: Day 29, 57, 85, 141 and 169
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