Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04497987
Previous Study | Return to List | Next Study

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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1180 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 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
Actual Study Start Date : August 2, 2020
Actual Primary Completion Date : January 16, 2021
Actual Study Completion Date : May 20, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Bamlanivimab (Part 1)
Participants received single Intravenous (IV) infusion of 4200 milligrams (mg) bamlanivimab.
 Drug: Bamlanivimab
Administered IV.
Other Names:
  • LY-CoV555
  • LY3819253
Placebo Comparator: Placebo (Part 1)
Participants received single IV infusion of Placebo.
 Drug: Placebo
Administered IV.
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.
 Drug: Bamlanivimab
Administered IV.
Other Names:
  • LY-CoV555
  • LY3819253
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.
 Drug: Bamlanivimab
Administered IV.
Other Names:
  • LY-CoV555
  • LY3819253

Drug: Etesevimab
Administered IV.
Other Names:
  • LY-CoV016
  • LY3832479
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.
 Drug: Placebo
Administered IV.
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.
 Drug: Bamlanivimab
Administered IV.
Other Names:
  • LY-CoV555
  • LY3819253
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.
 Drug: Bamlanivimab
Administered IV.
Other Names:
  • LY-CoV555
  • LY3819253

Drug: Etesevimab
Administered IV.
Other Names:
  • LY-CoV016
  • LY3832479
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.]

 Drug: Bamlanivimab
Administered IV.
Other Names:
  • LY-CoV555
  • LY3819253
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.]

 Drug: Bamlanivimab
Administered IV.
Other Names:
  • LY-CoV555
  • LY3819253

Drug: Etesevimab
Administered IV.
Other Names:
  • LY-CoV016
  • LY3832479


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

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

  3. 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.

  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.

  6. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
Show Show 27 study locations
Sponsors and Collaborators
Eli Lilly and Company
National Institute of Allergy and Infectious Diseases (NIAID)
AbCellera Biologics Inc.
Shanghai Junshi Bioscience Co., Ltd.
Investigators
Layout table for investigator information
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
  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] January 22, 2021
Statistical Analysis Plan  [PDF] December 7, 2020

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
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
Results First Posted: February 4, 2022
Last Update Posted: February 4, 2022
Last Verified: February 2022
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/

Layout table for additional information
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:
Layout table for MeSH terms
COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Bamlanivimab
Antiviral Agents
Anti-Infective Agents