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Completed

NCT Number: 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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sars-CoV2 Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Unv of AL Sch of Med Div of Infectious Diseases, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bamlanivimab

Drug

Administered IV.

Other names: LY-CoV555, LY3819253

Placebo

Drug

Administered IV.

Etesevimab

Drug

Administered IV.

Other names: LY-CoV016, LY3832479

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • AbCellera Biologics Inc.
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Shanghai Junshi Bioscience Co., Ltd.

Registry information

Official study 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

Acronym: BLAZE-2

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 4, 2020
Registry last updated
Feb 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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