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)

• ClinicalTrials.gov Identifier: NCT04497987
• Recruitment Status: Active, not recruiting
• First Posted: August 4, 2020
• Last Update Posted: April 20, 2021
• 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

• First Submitted Date: July 31, 2020
• First Posted Date: August 4, 2020
• Last Update Posted Date: April 20, 2021
• Actual Study Start Date: August 2, 2020
• Actual Primary Completion Date: January 16, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 23, 2020)

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

Original Primary Outcome Measures (submitted: July 31, 2020)

Percentage of Participants with SARS-CoV-2 Infection [ Time Frame: Week 4 ]

Percentage of Participants with SARS-CoV-2 Infection

Current Secondary Outcome Measures (submitted: December 23, 2020)

• Percentage of Participants with Moderate or Worse Severity COVID-19 within 21 Days of Detection [ Time Frame: Baseline through Week 8 ]
  Percentage of Participants with Moderate or Worse Severity COVID-19 within 21 Days of Detection
• Percentage of Participants with SARS-CoV-2 [ Time Frame: Baseline through Week 4 ]
  Percentage of Participants with SARS-CoV-2
• Percentage of Participants Who are Hospitalized or Have Died due to COVID-19 [ Time Frame: Week 8 ]
  Percentage of Participants Who are Hospitalized or Have Died due to COVID-19
• 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
• Percentage of Participants Who Die Due to COVID-19 [ Time Frame: Week 8 ]
  Percentage of Participants Who Die Due to COVID-19
• Pharmacokinetics (PK): Mean Concentration of LY3819253 Administered Alone [ Time Frame: Day 29 ]
  PK: Mean Concentration of LY3819253 Administered Alone
• PK: Mean Concentration of LY3819253 in the Presence of LY3832479 [ Time Frame: Day 29 ]
  PK: Mean Concentration of LY3819253 in the Presence of LY3832479
• PK: Mean Concentration of LY3832479 in the Presence of LY3819253 [ Time Frame: Day 29 ]
  PK: Mean Concentration of LY3832479 in the Presence of LY3819253

Original Secondary Outcome Measures (submitted: July 31, 2020)

• Percentage of Participants with Moderate or Worse Severity COVID-19 [ Time Frame: Week 8 ]
  Percentage of Participants with Moderate or Worse Severity COVID-19
• Percentage of Participants with Mild or Worse Severity COVID-19 [ Time Frame: Week 8 ]
  Percentage of Participants with Mild or Worse Severity COVID-19
• Percentage of Participants Who are Hospitalized due to COVID-19 [ Time Frame: Week 8 ]
  Percentage of Participants Who are Hospitalized due to COVID-19
• 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
• Percentage of Participants Who Die Due to COVID-19 [ Time Frame: Week 8 ]
  Percentage of Participants Who Die Due to COVID-19

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention

Condition

• COVID-19
• SARS-CoV2

Intervention

• Drug: LY3819253
  Administered IV.
  Other Names:

  • LY-CoV555
  • Bamlanivimab
• Drug: Placebo
  Administered IV.
• Drug: LY3832479
  Administered IV.
  Other Names:

  • LY-CoV016
  • Etesevimab

Study Arms

• Experimental: LY3819253 (Part 1)
  LY3819253 administered intravenously (IV).
  Intervention: Drug: LY3819253
• Placebo Comparator: Placebo (Part 1)
  Placebo administered IV.
  Intervention: Drug: Placebo
• Experimental: LY3819253 (Part 2 - Prevention)
  LY3819253 administered IV to prevention cohort.
  Intervention: Drug: LY3819253
• Experimental: LY3819253 + LY3832479 (Part 2 - Prevention)
  LY3819253 + LY3832479 administered IV to prevention cohort.
  Interventions:

  • Drug: LY3819253
  • Drug: LY3832479
• Placebo Comparator: Placebo (Part 2 - Prevention)
  Placebo administered IV to prevention cohort.
  Intervention: Drug: Placebo
• Experimental: LY3819253 (Part 2 - Treatment)
  LY3819253 administered IV to treatment cohort.
  Intervention: Drug: LY3819253
• Experimental: LY3819253 + LY3832479 (Part 2 - Treatment)
  LY3819253 + LY3832479 administered IV to treatment cohort.
  Interventions:

  • Drug: LY3819253
  • Drug: LY3832479
• Experimental: LY3819253 (Part 3 - Treatment)
  LY3819253 administered IV.
  Intervention: Drug: LY3819253
• Experimental: LY3819253 + LY3832479 (Part 3 - Treatment)
  LY3819253 + LY3832479 administered IV.
  Interventions:

  • Drug: LY3819253
  • Drug: LY3832479

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: December 23, 2020): 5000
• Original Estimated Enrollment (submitted: July 31, 2020): 2400
• Estimated Study Completion Date: June 29, 2021
• Actual Primary Completion Date: January 16, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Part 1 and Part 2: Resident or facility staff in a skilled nursing or assisted living facility with at least one confirmed case of 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

• Part 3 only: Resident or staff in a skilled nursing or assisted living facility who satisfy at least one of the following at the time of screening

  • Are greater than or equal to (≥) 65 years of age
  • Have a body mass index (BMI) ≥ 35
  • Have chronic kidney disease
  • Have type 1 or type 2 diabetes
  • Have immunosuppressive disease
  • Are currently receiving immunosuppressive treatment, or

  • Are ≥ 55 years of age AND have

    • cardiovascular disease, OR
    • hypertension, OR
    • chronic obstructive pulmonary disease or other chronic respiratory disease
• Positive SARS-CoV-2 test and infusion within 10 days of symptom onset, OR positive SARS-CoV-2 test and infusion within 10 days of testing if asymptomatic

Exclusion Criteria:

• Parts 1 and 2:

  • Recovered from confirmed COVID-19 disease or asymptomatic infection
  • Prior history of a positive SARS-CoV-2 serology test
  • History of convalescent COVID-19 plasma treatment
  • Participation in a previous SARS-CoV-2 vaccine trial or received an approved SARS-CoV-2 vaccine
  • 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: 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) )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

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
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: 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/

• Responsible Party: Eli Lilly and Company
• Study Sponsor: Eli Lilly and Company

Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)
• AbCellera Biologics Inc.
• Shanghai Junshi Bioscience Co., Ltd.

Investigators

• 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

• PRS Account: Eli Lilly and Company
• Verification Date: April 2021