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

COVID-19 Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04497987
• Other study ID #: 18063
• Secondary ID: J2X-MC-PYADCoVPN
• Status: Completed
• Phase: Phase 3
• Start date: August 2, 2020
• Est. completion date: May 20, 2021

Study information

• Verified date: February 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1180
• Est. completion date: May 20, 2021
• Est. primary completion date: January 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV2

Intervention

Drug:
• Bamlanivimab
Administered IV.
• Placebo
Administered IV.
• Etesevimab
Administered IV.

Locations

Country	Name	City	State
United States	University of Colorado-Anschultz Medical Campus	Aurora	Colorado
United States	Donahoe Manor	Bedford	Pennsylvania
United States	Allergy and Asthma Clin of NW Ark	Bentonville	Arkansas
United States	NIAID - National Institute of Allergy & Infectious Diseases	Bethesda	Maryland
United States	Unv of AL Sch of Med Div of Infectious Diseases	Birmingham	Alabama
United States	Care Access	Boston	Massachusetts
United States	Care Access Research - Bronx	Bronx	New York
United States	Burke Internal Medicine and Research	Burke	Virginia
United States	Valley Medical Primary Care	Centerville	Ohio
United States	NIAD	Chapel Hill	North Carolina
United States	Univ of Cin College of Med	Cincinnati	Ohio
United States	NIAID	Decatur	Georgia
United States	Belmont Village, West Univ	Houston	Texas
United States	Care Access Research LLC	Huntington Beach	California
United States	Family Medicine	Indianapolis	Indiana
United States	Care Access	Jackson	Mississippi
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Care Access Rch Lake Charles	Lake Charles	Louisiana
United States	Belmont Village Lincoln Park	Lincoln Park	Illinois
United States	University of Louisville	Louisville	Kentucky
United States	NIAID	Miami	Florida
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	Alta Bates SMC	Oakland	California
United States	Children's Hospital & Medical Center	Omaha	Nebraska
United States	Care Access Research	Phoenix	Arizona
United States	St. Paul IDA-CARe	Saint Paul	Minnesota
United States	OSU Med Intl Med Houston Ctr	Tulsa	Oklahoma

Sponsors (4)

Lead Sponsor	Collaborator
Eli Lilly and Company	AbCellera Biologics Inc., National Institute of Allergy and Infectious Diseases (NIAID), Shanghai Junshi Bioscience Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 8 after randomization
Secondary	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.	Week 8 after randomization
Secondary	Percentage of Participants With SARS-CoV-2	Percentage of Participants with SARS-CoV-2.	Week 4
Secondary	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.	Week 8
Secondary	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.	Week 8
Secondary	Percentage of Participants Who Die Due to COVID-19	Percentage of Participants Who Die Due to COVID-19.	Week 8
Secondary	Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Administered Alone	Pharmacokinetics (PK): Mean Concentration of bamlanivimab Administered Alone.	Day 29, 57, 85, 141 and 169

External Links

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