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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)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04497987
Recruitment Status : Completed
First Posted : August 4, 2020
Results First Posted : February 4, 2022
Last Update Posted : February 4, 2022
Sponsor:
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  ICMJE July 31, 2020
First Posted Date  ICMJE August 4, 2020
Results First Submitted Date  ICMJE January 11, 2022
Results First Posted Date  ICMJE February 4, 2022
Last Update Posted Date February 4, 2022
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
 (submitted: February 2, 2022)
Percentage of Participants With COVID-19 [ Time Frame: Week 8 after randomization ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 31, 2020)
Percentage of Participants with SARS-CoV-2 Infection [ Time Frame: Week 4 ]
Percentage of Participants with SARS-CoV-2 Infection
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2022)
  • Percentage of Participants With Moderate or Worse Severity COVID-19 [ Time Frame: Week 8 after randomization ]
    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.
  • Percentage of Participants With SARS-CoV-2 [ Time Frame: 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 Bamlanivimab Administered Alone [ Time Frame: Day 29, 57, 85, 141 and 169 ]
    Pharmacokinetics (PK): Mean Concentration of bamlanivimab Administered Alone.
Original Secondary Outcome Measures  ICMJE
 (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  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
Condition  ICMJE
  • COVID-19
  • SARS-CoV2
Intervention  ICMJE
  • Drug: Bamlanivimab
    Administered IV.
    Other Names:
    • LY-CoV555
    • LY3819253
  • Drug: Placebo
    Administered IV.
  • Drug: Etesevimab
    Administered IV.
    Other Names:
    • LY-CoV016
    • LY3832479
Study Arms  ICMJE
  • Experimental: Bamlanivimab (Part 1)
    Participants received single Intravenous (IV) infusion of 4200 milligrams (mg) bamlanivimab.
    Intervention: Drug: Bamlanivimab
  • Placebo Comparator: Placebo (Part 1)
    Participants received single IV infusion of Placebo.
    Intervention: Drug: Placebo
  • Experimental: Bamlanivimab (Part 2-Prevention)
    Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.
    Intervention: Drug: Bamlanivimab
  • Experimental: Bamlanivimab + Etesevimab (Part 2-Prevention)
    Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.
    Interventions:
    • Drug: Bamlanivimab
    • Drug: Etesevimab
  • Placebo Comparator: Placebo Comparator: Placebo (Part 2-Prevention)
    Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.
    Intervention: Drug: Placebo
  • Experimental: Bamlanivimab (Part 2 - Treatment)
    Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.
    Intervention: Drug: Bamlanivimab
  • Experimental: Bamlanivimab + Etesevimab (Part 2- Treatment)
    Enrollment for Part 2 was not initiated because the efficacy of Bamlanivimab 4200 mg observed in Part 1 significantly diminished the feasibility of enrolling Part 2.
    Interventions:
    • Drug: Bamlanivimab
    • Drug: Etesevimab
  • Experimental: Bamlanivimab (Part 3)

    Part 3 of the study is exploratory, conducted to study exploratory objectives and is not reported in this record.

    [Participants received single IV infusion of 700 mg bamlanivimab.]

    Intervention: Drug: Bamlanivimab
  • Experimental: Bamlanivimab + Etesevimab (Part 3)

    Part 3 of the study is exploratory, conducted to study exploratory objectives and is not reported in this record.

    [Participants received single IV infusion of 700 mg bamlanivimab given with 1400 mg etesevimab.]

    Interventions:
    • Drug: Bamlanivimab
    • Drug: Etesevimab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2022)
1180
Original Estimated Enrollment  ICMJE
 (submitted: July 31, 2020)
2400
Actual Study Completion Date  ICMJE May 20, 2021
Actual Primary Completion Date January 16, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
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) )
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  ICMJE
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/
Current Responsible Party Eli Lilly and Company
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Eli Lilly and Company
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • AbCellera Biologics Inc.
  • Shanghai Junshi Bioscience Co., Ltd.
Investigators  ICMJE
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 February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP