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NCT04497987 · ClinicalTrials.gov registry record · Phase 3
A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Preventing SARS-CoV-2 Infection and COVID-19 in Nursing Home Residents and Staff
A Phase 3 study of COVID-19 and SARS-CoV-2, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,180
- Enrollment target
- 20
- Study locations
NCT04497987: Completed Phase 3 study of COVID-19 and SARS-CoV-2, sponsored by Eli Lilly and Company.
NCT04497987 is a Phase 3 study of COVID-19 and SARS-CoV-2 that has completed, run by Eli Lilly and Company. The registered enrollment target is 1,180 participants, below the 38,461-participant average among 298 other COVID-19 trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04497987, a Phase 3 study of COVID-19 and SARS-CoV-2, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,180 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
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 positi
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Bamlanivimab
- DRUG Etesevimab
Study Locations (20)
California
- Care Access Research LLC - Huntington Beach
- Alta Bates SMC - Oakland
Louisiana
- Care Access Rch Lake Charles - Lake Charles
- Tulane University School of Medicine - New Orleans
Mississippi
- Care Access - Jackson
- University of Mississippi Medical Center - Jackson
Alabama
- Unv of AL Sch of Med Div of Infectious Diseases - Birmingham
Arizona
- Care Access Research - Phoenix
Arkansas
- Allergy and Asthma Clin of NW Ark - Bentonville
Colorado
- University of Colorado-Anschultz Medical Campus - Aurora
Florida
- NIAID - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,180 participants |
| Start Date | 2020-08-02 |
| Est. Completion | 2021-05-20 |
| Phase | Phase 3 |
What the finished NCT04497987 record still lists
NCT04497987 is an interventional study that assigns participants to a tested intervention. Its 1,180 participants enrollment target places it among the larger protocols in the corpus, below the 38,461-participant average among 298 other COVID-19 trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with COVID-19 appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04497987 names 20 study sites across 17 states, led by California, Louisiana, Mississippi.
Frequently Asked Questions
What is clinical trial NCT04497987 about?
NCT04497987 is a clinical study titled "A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Preventing SARS-CoV-2 Infection and COVID-19 in Nursing Home Residents and Staff". 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 ...
What is the current status of trial NCT04497987?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,180 participants. The study started on 2020-08-02. Estimated completion is 2021-05-20.
What conditions does trial NCT04497987 study?
This clinical trial studies the following conditions: COVID-19, SARS-CoV-2.
What interventions are being tested in trial NCT04497987?
The interventions under investigation include: Placebo (DRUG), Bamlanivimab (DRUG), Etesevimab (DRUG).
Who is sponsoring clinical trial NCT04497987?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04497987 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04497987's enrollment target sits among peer trials
1,180 65th of 298 higher than 234 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
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