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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,180
- 试验地点
- 25
- 主要终点
- Percentage of Participants With COVID-19
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Bamlanivimab (Part 1)
Participants received single Intravenous (IV) infusion of 4200 milligrams (mg) bamlanivimab.
干预措施: Bamlanivimab (Drug)
Placebo (Part 1)
Participants received single IV infusion of Placebo.
干预措施: Placebo (Drug)
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.
干预措施: Etesevimab (Drug)
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.
干预措施: Bamlanivimab (Drug)
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.
干预措施: Bamlanivimab (Drug)
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.
干预措施: Placebo (Drug)
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.
干预措施: Bamlanivimab (Drug)
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.
干预措施: Bamlanivimab (Drug)
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.
干预措施: Etesevimab (Drug)
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.]
干预措施: Bamlanivimab (Drug)
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.]
干预措施: Bamlanivimab (Drug)
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.]
干预措施: Etesevimab (Drug)
结局指标
主要结局
Percentage of Participants With COVID-19
时间窗: 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.
次要结局
- Percentage of Participants With Moderate or Worse Severity COVID-19(Week 8 after randomization)
- Percentage of Participants With SARS-CoV-2(Week 4)
- Percentage of Participants Who Are Hospitalized or Have Died Due to COVID-19(Week 8)
- Percentage of Participants Who Experience COVID-19-Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death(Week 8)
- Percentage of Participants Who Die Due to COVID-19(Week 8)
- Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Administered Alone(Day 29, 57, 85, 141 and 169)