Back to resultsA 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)
Primary Purpose
COVID-19, SARS-CoV2
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bamlanivimab
Placebo
Etesevimab
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring Prevention
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
Sites / Locations
- Unv of AL Sch of Med Div of Infectious Diseases
- Care Access Research
- Allergy and Asthma Clin of NW Ark
- Care Access Research LLC
- Alta Bates SMC
- University of Colorado-Anschultz Medical Campus
- NIAID
- NIAID
- Belmont Village Lincoln Park
- Family Medicine
- University of Louisville
- Care Access Rch Lake Charles
- Tulane University School of Medicine
- NIAID - National Institute of Allergy & Infectious Diseases
- Care Access
- St. Paul IDA-CARe
- Care Access
- University of Mississippi Medical Center
- Children's Hospital & Medical Center
- Care Access Research - Bronx
- NIAD
- Valley Medical Primary Care
- Univ of Cin College of Med
- OSU Med Intl Med Houston Ctr
- Donahoe Manor
- Belmont Village, West Univ
- Burke Internal Medicine and Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm Type
Experimental
Placebo Comparator
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Arm Label
Bamlanivimab (Part 1)
Placebo (Part 1)
Bamlanivimab (Part 2-Prevention)
Bamlanivimab + Etesevimab (Part 2-Prevention)
Placebo Comparator: Placebo (Part 2-Prevention)
Bamlanivimab (Part 2 - Treatment)
Bamlanivimab + Etesevimab (Part 2- Treatment)
Bamlanivimab (Part 3)
Bamlanivimab + Etesevimab (Part 3)
Arm Description
Participants received single Intravenous (IV) infusion of 4200 milligrams (mg) bamlanivimab.
Participants received single IV infusion of Placebo.
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.
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.
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.
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.
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.
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.]
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.]
Outcomes
Primary Outcome Measures
Percentage of Participants With COVID-19
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
Percentage of Participants With Moderate or Worse Severity COVID-19
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
Percentage of Participants with SARS-CoV-2.
Percentage of Participants Who Are Hospitalized or Have Died Due to COVID-19
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
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
Percentage of Participants Who Die Due to COVID-19.
Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Administered Alone
Pharmacokinetics (PK): Mean Concentration of bamlanivimab Administered Alone.
Full Information
NCT ID
NCT04497987
First Posted
July 31, 2020
Last Updated
February 2, 2022
Sponsor
Eli Lilly and Company
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), AbCellera Biologics Inc., Shanghai Junshi Bioscience Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04497987
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
Acronym
BLAZE-2
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 2, 2020 (Actual)
Primary Completion Date
January 16, 2021 (Actual)
Study Completion Date
May 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), AbCellera Biologics Inc., Shanghai Junshi Bioscience Co., Ltd.
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV2
Keywords
Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bamlanivimab (Part 1)
Arm Type
Experimental
Arm Description
Participants received single Intravenous (IV) infusion of 4200 milligrams (mg) bamlanivimab.
Arm Title
Placebo (Part 1)
Arm Type
Placebo Comparator
Arm Description
Participants received single IV infusion of Placebo.
Arm Title
Bamlanivimab (Part 2-Prevention)
Arm Type
Experimental
Arm Description
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.
Arm Title
Bamlanivimab + Etesevimab (Part 2-Prevention)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Comparator: Placebo (Part 2-Prevention)
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Bamlanivimab (Part 2 - Treatment)
Arm Type
Experimental
Arm Description
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.
Arm Title
Bamlanivimab + Etesevimab (Part 2- Treatment)
Arm Type
Experimental
Arm Description
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.
Arm Title
Bamlanivimab (Part 3)
Arm Type
Experimental
Arm Description
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.]
Arm Title
Bamlanivimab + Etesevimab (Part 3)
Arm Type
Experimental
Arm Description
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.]
Intervention Type
Drug
Intervention Name(s)
Bamlanivimab
Other Intervention Name(s)
LY-CoV555, LY3819253
Intervention Description
Administered IV.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered IV.
Intervention Type
Drug
Intervention Name(s)
Etesevimab
Other Intervention Name(s)
LY-CoV016, LY3832479
Intervention Description
Administered IV.
Primary Outcome Measure Information:
Title
Percentage of Participants With COVID-19
Description
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.
Time Frame
Week 8 after randomization
Secondary Outcome Measure Information:
Title
Percentage of Participants With Moderate or Worse Severity COVID-19
Description
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.
Time Frame
Week 8 after randomization
Title
Percentage of Participants With SARS-CoV-2
Description
Percentage of Participants with SARS-CoV-2.
Time Frame
Week 4
Title
Percentage of Participants Who Are Hospitalized or Have Died Due to COVID-19
Description
Percentage of Participants Who are Hospitalized or Have Died due to COVID-19.
Time Frame
Week 8
Title
Percentage of Participants Who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death
Description
Percentage of Participants who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death.
Time Frame
Week 8
Title
Percentage of Participants Who Die Due to COVID-19
Description
Percentage of Participants Who Die Due to COVID-19.
Time Frame
Week 8
Title
Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Administered Alone
Description
Pharmacokinetics (PK): Mean Concentration of bamlanivimab Administered Alone.
Time Frame
Day 29, 57, 85, 141 and 169
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Unv of AL Sch of Med Div of Infectious Diseases
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Care Access Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Allergy and Asthma Clin of NW Ark
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72712
Country
United States
Facility Name
Care Access Research LLC
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
Alta Bates SMC
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
University of Colorado-Anschultz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
NIAID
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
NIAID
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Belmont Village Lincoln Park
City
Lincoln Park
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Family Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Care Access Rch Lake Charles
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Tulane University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112 2715
Country
United States
Facility Name
NIAID - National Institute of Allergy & Infectious Diseases
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Care Access
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02110
Country
United States
Facility Name
St. Paul IDA-CARe
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Care Access
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39206
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Children's Hospital & Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Care Access Research - Bronx
City
Bronx
State/Province
New York
ZIP/Postal Code
10456
Country
United States
Facility Name
NIAD
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Valley Medical Primary Care
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Univ of Cin College of Med
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
OSU Med Intl Med Houston Ctr
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74127
Country
United States
Facility Name
Donahoe Manor
City
Bedford
State/Province
Pennsylvania
ZIP/Postal Code
15522
Country
United States
Facility Name
Belmont Village, West Univ
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Burke Internal Medicine and Research
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/
Citations:
PubMed Identifier
35713300
Citation
Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
Results Reference
derived
PubMed Identifier
34473343
Citation
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Results Reference
derived
PubMed Identifier
34374951
Citation
Nathan R, Shawa I, De La Torre I, Pustizzi JM, Haustrup N, Patel DR, Huhn G. A Narrative Review of the Clinical Practicalities of Bamlanivimab and Etesevimab Antibody Therapies for SARS-CoV-2. Infect Dis Ther. 2021 Dec;10(4):1933-1947. doi: 10.1007/s40121-021-00515-6. Epub 2021 Aug 10.
Results Reference
derived
PubMed Identifier
34081073
Citation
Cohen MS, Nirula A, Mulligan MJ, Novak RM, Marovich M, Yen C, Stemer A, Mayer SM, Wohl D, Brengle B, Montague BT, Frank I, McCulloh RJ, Fichtenbaum CJ, Lipson B, Gabra N, Ramirez JA, Thai C, Chege W, Gomez Lorenzo MM, Sista N, Farrior J, Clement ME, Brown ER, Custer KL, Van Naarden J, Adams AC, Schade AE, Dabora MC, Knorr J, Price KL, Sabo J, Tuttle JL, Klekotka P, Shen L, Skovronsky DM; BLAZE-2 Investigators. Effect of Bamlanivimab vs Placebo on Incidence of COVID-19 Among Residents and Staff of Skilled Nursing and Assisted Living Facilities: A Randomized Clinical Trial. JAMA. 2021 Jul 6;326(1):46-55. doi: 10.1001/jama.2021.8828.
Results Reference
derived
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/6hAC2UjP12uxz1fFWVGSKC
Description
A Study of LY3819253 (LY-CoV555) to Prevent SARS-CoV-2 Infection and COVID-19 in Nursing Home Residents and Staff (BLAZE-2)
Learn more about this trial
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
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