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 (BLAZE-2)
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ClinicalTrials.gov Identifier: NCT04497987 |
Recruitment Status :
Active, not recruiting
First Posted : August 4, 2020
Last Update Posted : April 20, 2021
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Sponsor:
Eli Lilly and Company
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
AbCellera Biologics Inc.
Shanghai Junshi Bioscience Co., Ltd.
Information provided by (Responsible Party):
Eli Lilly and Company
Tracking Information | |||||||||||||||||
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First Submitted Date ICMJE | July 31, 2020 | ||||||||||||||||
First Posted Date ICMJE | August 4, 2020 | ||||||||||||||||
Last Update Posted Date | April 20, 2021 | ||||||||||||||||
Actual Study Start Date ICMJE | August 2, 2020 | ||||||||||||||||
Actual Primary Completion Date | January 16, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
Percentage of Participants with COVID-19 within 21 Days of Detection [ Time Frame: Baseline through Week 8 ] Percentage of Participants with COVID-19 within 21 Days of Detection
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Original Primary Outcome Measures ICMJE |
Percentage of Participants with SARS-CoV-2 Infection [ Time Frame: Week 4 ] Percentage of Participants with SARS-CoV-2 Infection
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Change History | |||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | 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 | ||||||||||||||||
Official Title ICMJE | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of LY3819253 Alone and in Combination With LY3832479 in Preventing SARS-CoV-2 Infection and COVID-19 in Skilled Nursing and Assisted Living Facility Residents and Staff; a NIAID and Lilly Collaborative Study | ||||||||||||||||
Brief 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. | ||||||||||||||||
Detailed Description | Not Provided | ||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase ICMJE | Phase 3 | ||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||||
Estimated Enrollment ICMJE |
5000 | ||||||||||||||||
Original Estimated Enrollment ICMJE |
2400 | ||||||||||||||||
Estimated Study Completion Date ICMJE | June 29, 2021 | ||||||||||||||||
Actual Primary Completion Date | January 16, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
Listed Location Countries ICMJE | United States | ||||||||||||||||
Removed Location Countries | |||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT04497987 | ||||||||||||||||
Other Study ID Numbers ICMJE | 18063 J2X-MC-PYAD ( Other Identifier: Eli Lilly and Company ) CoVPN #3501 ( Other Identifier: National Institute of Allergy and Infectious Diseases (NIAID) ) |
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Has Data Monitoring Committee | Yes | ||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Eli Lilly and Company | ||||||||||||||||
Study Sponsor ICMJE | Eli Lilly and Company | ||||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Eli Lilly and Company | ||||||||||||||||
Verification Date | April 2021 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |