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A Study of LY3819253 (LY-CoV555) in Preventing SARS-CoV-2 Infection and COVID-19 in Nursing Home Residents and Staff (BLAZE-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04497987
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : October 20, 2020
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
AbCellera Biologics Inc.
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to evaluate whether LY3819253 prevents severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease - 2019 (COVID-19) in facility staff and residents in contracted skilled nursing and assisted living facility networks with a high risk of SARS-CoV-2 exposure. Participants with a high risk of SARS-CoV-2 exposure will receive LY3819253 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.

Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV2 Drug: LY3819253 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of LY3819253 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
Actual Study Start Date : August 2, 2020
Estimated Primary Completion Date : March 8, 2021
Estimated Study Completion Date : June 29, 2021

Arm Intervention/treatment
Experimental: LY3819253
LY3819253 administered intravenously (IV).
Drug: LY3819253
Administered IV.
Other Name: LY-CoV555

Placebo Comparator: Placebo
Placebo administered IV.
Drug: Placebo
Administered IV.




Primary Outcome Measures :
  1. Percentage of Participants with SARS-CoV-2 Infection [ Time Frame: Week 4 ]
    Percentage of Participants with SARS-CoV-2 Infection


Secondary Outcome Measures :
  1. Percentage of Participants with Moderate or Worse Severity COVID-19 [ Time Frame: Week 8 ]
    Percentage of Participants with Moderate or Worse Severity COVID-19

  2. Percentage of Participants with Mild or Worse Severity COVID-19 [ Time Frame: Week 8 ]
    Percentage of Participants with Mild or Worse Severity COVID-19

  3. Percentage of Participants Who are Hospitalized due to COVID-19 [ Time Frame: Week 8 ]
    Percentage of Participants Who are Hospitalized due to COVID-19

  4. 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 Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death

  5. Percentage of Participants Who Die Due to COVID-19 [ Time Frame: Week 8 ]
    Percentage of Participants Who Die Due to COVID-19



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Resident or facility staff in a skilled nursing or assisted living facility with at least one confirmed case of direct SARS-CoV-2 detection less than or equal to (≤)7 days prior to randomization
  • Are men or non-pregnant women who agree to contraceptive requirements
  • Agree to the collection of nasal, mid-turbinate, oropharyngeal, and nasopharyngeal swabs, and venous blood as specified in the schedule of activities
  • Have venous access sufficient to allow intravenous infusions and blood sampling
  • The participant or legally authorized representative give signed informed consent

Exclusion Criteria:

  • Recovered from confirmed COVID-19 disease
  • A prior history of a positive SARS-CoV-2 serology test
  • A history of convalescent COVID-19 plasma treatment
  • Participation in a previous SARS-CoV-2 vaccine trial
  • Previous receipt of SAR-CoV-2-specific monoclonal antibodies
  • Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04497987


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Clinicaltrials.gov@lilly.com

Locations
Show Show 26 study locations
Sponsors and Collaborators
Eli Lilly and Company
National Institute of Allergy and Infectious Diseases (NIAID)
AbCellera Biologics Inc.
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04497987    
Other Study ID Numbers: 18063
J2X-MC-PYAD ( Other Identifier: Eli Lilly and Company )
CoVPN #3501 ( Other Identifier: National Institute of Allergy and Infectious Diseases (NIAID) )
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Eli Lilly and Company:
Prevention
Additional relevant MeSH terms:
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Infection