Clinical trial NCT04497987: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19
SARS-CoV2
Keywords: Prevention
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: AbCellera Biologics Inc.
name: Shanghai Junshi Bioscience Co., Ltd.
First posted: 2020-08-04
Enrollment: 1180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Percentage of Participants With COVID-19
timeFrame: Week 8 after randomization
Secondary outcomes:
measure: Percentage of Participants With Moderate or Worse Severity COVID-19
timeFrame: Week 8 after randomization
measure: Percentage of Participants With SARS-CoV-2
timeFrame: Week 4
measure: Percentage of Participants Who Are Hospitalized or Have Died Due to COVID-19
timeFrame: Week 8
measure: Percentage of Participants Who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death
timeFrame: Week 8
measure: Percentage of Participants Who Die Due to COVID-19
timeFrame: Week 8
measure: Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Administered Alone
timeFrame: Day 29, 57, 85, 141 and 169
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Unv of AL Sch of Med Div of Infectious Diseases
state: Alabama
city: Phoenix
country: United States
facility: Care Access Research
state: Arizona
city: Bentonville
country: United States
facility: Allergy and Asthma Clin of NW Ark
state: Arkansas
city: Huntington Beach
country: United States
facility: Care Access Research LLC
state: California
city: Oakland
country: United States
facility: Alta Bates SMC
state: California
city: Aurora
country: United States
facility: University of Colorado-Anschultz Medical Campus
state: Colorado
city: Miami
country: United States
facility: NIAID
state: Florida
city: Decatur
country: United States
facility: NIAID
state: Georgia
city: Lincoln Park
country: United States
facility: Belmont Village Lincoln Park
state: Illinois
city: Indianapolis
country: United States
facility: Family Medicine
state: Indiana
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Lake Charles
country: United States
facility: Care Access Rch Lake Charles
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
city: Bethesda
country: United States
facility: NIAID - National Institute of Allergy & Infectious Diseases
state: Maryland
city: Boston
country: United States
facility: Care Access
state: Massachusetts
city: Saint Paul
country: United States
facility: St. Paul IDA-CARe
state: Minnesota
city: Jackson
country: United States
facility: Care Access
state: Mississippi
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Omaha
country: United States
facility: Children's Hospital & Medical Center
state: Nebraska
city: Bronx
country: United States
facility: Care Access Research - Bronx
state: New York
city: Chapel Hill
country: United States
facility: NIAD
state: North Carolina
city: Centerville
country: United States
facility: Valley Medical Primary Care
state: Ohio
city: Cincinnati
country: United States
facility: Univ of Cin College of Med
state: Ohio
city: Tulsa
country: United States
facility: OSU Med Intl Med Houston Ctr
state: Oklahoma
city: Bedford
country: United States
facility: Donahoe Manor
state: Pennsylvania
city: Houston
country: United States
facility: Belmont Village, West Univ
state: Texas
city: Burke
country: United States
facility: Burke Internal Medicine and Research
state: Virginia
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.