Bacillus Calmette-Guerin Against Covid-19 for Prevention and Amelioration of Severity Trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- To assess the efficacy of BCG vaccination compared to placebo in reducing severe Covid-19 disease among elderly residents of skilled nursing facilities.
研究概览
简要总结
The purpose of this study is to assess the efficacy of Bacille Calmette-Guérin (BCG) vaccination compared to placebo in reducing severe Covid-19 disease among elderly residents of skilled nursing facilities. The investigators hypothesize that BCG vaccination can reduce severity of Covid-19 disease. Patients who are residents of participating long-term care facilities (LTCFs), with the ability to understand and cooperate with study procedures, who agree to participate in the study will be randomly assigned to receive BCG vaccination or a placebo. Participants will be followed for up to twelve months to assess severity of Covid-19 outcomes.
详细描述
This is a Phase III, double-blind, randomized placebo-controlled trial comparing efficacy of BCG vaccination to that of placebo in reducing severity of Covid-19. Participants will need to meet eligibility criteria in order to be included in the study. Those selected, will be asked to provide a blood or saliva sample for Covid-19 serological test and an Interferon gamma release assay (IGRA) test for tuberculosis infection, only if IGRA or tuberculin skin test (TST) result is not available from the previous year. Participants will be randomized in a 1:1 allocation to receive intradermal administration of BCG vaccination or placebo at baseline. During follow-up, the study team will extract participants information from nursing home records regarding Covid-19-like symptoms, diagnosis, outcomes, as well as any adverse side effects of BCG vaccination. At 6 and 12 months of follow up, an additional blood or saliva sample will be collected to perform a Covid-19 serological test.
The investigators will screen 2,500 individuals to enroll 2,100 participants, resulting in 1,050 receiving BCG vaccine and 1,050 receiving placebo. The proposed enrollment sample size is designed to provide 80% power to detect 60% vaccine efficacy (a relative risk of 0.4 among the vaccinated) with 0.05 type-1 error in a two-tailed test, assuming a Covid-19 attack rate of 10% in elderly NH and 38.5% severe Covid-19 among the infected patients, and a design effect = 1.2, and 15% lost during the 6-month follow-up. The number of individuals screened assumes about 20% will not be eligible/agree to be enrolled.
Note that the 60% vaccine efficacy was based on the observed three-fold decline in respiratory infections in the adolescent cohort.
Objective: To assess the efficacy of BCG vaccination compared to placebo in reducing severe Covid-19 disease among elderly residents of skilled nursing facilities.
Primary Endpoint 1: Cases of Covid-19 disease classified as severe. Severe COVID-19 disease will be defined as: COVID-19 disease with hospitalization, death, or non-hospitalized severe disease where non-hospitalized severe disease is defined as a change in status including administration of new supplemental oxygen or decline in oxygen saturation of 10%; change from ambulant to non-ambulant status of 3+ days; new change in mental status as documented in the electronic health record
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants and investigators and designated staff whose responsibility will be to administer the BCG vaccine or placebo will be blinded.
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BCG Vaccine
Participants randomized to the BCG arm will receive BCG vaccine. The vaccination site is about halfway down the outer aspect of the upper arm.
干预措施: BCG Vaccine (Drug)
Placebo Arm
Placebo will be administered in an intradermal route in the same location as the BCG vaccines: upper arm.
干预措施: Placebo (Other)
结局指标
主要结局
To assess the efficacy of BCG vaccination compared to placebo in reducing severe Covid-19 disease among elderly residents of skilled nursing facilities.
时间窗: 12 months
Number of people diagnosed with severe Covid-19 disease as documented in the electronic heath record; severe Covid-19 disease is defined as any instance of death, hospitalization, or non-hospitalization but requiring new administration of supplemental oxygen or having a decline in oxygen saturation of 10%, change from ambulant to non-ambulant for 3 or more days, or any new change in mental health status.
次要结局
- To assess the efficacy of BCG vaccination compared to placebo in reducing the following among elderly residents of skilled nursing facilities (by number of cases), continued(12 months)
- To assess the efficacy of BCG vaccination compared to placebo in reducing the following among elderly residents of skilled nursing facilities (by number of cases)(12 months)
- To assess the efficacy of BCG vaccination compared to placebo in reducing the following among elderly residents of skilled nursing facilities (by number of episodes)(12 months)
- To assess the efficacy of BCG vaccination compared to placebo in reducing the following among elderly residents of skilled nursing facilities (by number of days)(12 months)
研究者
Megan Murray, MD, ScD
Ronda Stryker and William Johnston Professor of Global Health
Harvard Medical School (HMS and HSDM)