Study to Evaluate the Effectiveness of BCG Vaccine in Reducing Morbidity and Mortality in Elderly Individuals in COVID-19 Hotspots in India
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,175
- 试验地点
- 2
- 主要终点
- Mortality due to COVID-19 disease
研究概览
简要总结
Rationale: SARS-CoV2 viral infection is spreading rapidly throughout the world and in India the epidemic poses a major threat to the public health system. Elderly individuals, especially those with diabetes, hypertension, other chronic diseases are at high risk of mortality. Strategies to protect these individuals are desperately needed to safeguard continuous patient care. Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other respiratory tract infections in in-vitro and in-vivo studies, and reported significant reductions in morbidity and mortality. Based on the capacity of BCG to reduce the incidence of respiratory tract infections in children and adults, to exert antiviral effects in experimental models; and to reduce viremia in an experimental human model of viral infection, the hypothesis is that BCG vaccination will partially protect against mortality in high-risk, elderly individuals.
Primary Objective: To evaluate the effectiveness of BCG vaccination in preventing morbidity and mortality due to COVID-19 in elderly individuals aged between 60 to 80 years living in COVID-19 hotspots in India.
Secondary objectives:
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To evaluate the effectiveness of BCG vaccination in terms of
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reducing the cumulative incidence of hospital admission and Intensive Care admission
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reducing the incidence of other respiratory febrile illness
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To determine the innate and adaptive immune responses, IgM, IgG and IgA antibody titers generated by BCG vaccination (both total and SARS-Cov2 specific) in a subset of individuals.
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To measure biomarkers induced by BCG vaccination as correlates of risk/protection against SARS-Cov2 in a subset of individuals
Method and Analysis:
Study design: Intervention study Study population: Elderly 60 - 80 years of age residing in designated hotspots for SARS-Cov2 infection Study Intervention: One dose of 0.1ml BCG vaccine, given intradermally. Elderly individuals not vaccinated from the same hotspot area or from neighbouring hotspot wards areas will be considered as the controls. Study sites: Chennai, Mumbai, Ahmedabad, Bhopal, Jodhpur and New Delhi. Study Sample size: 1450 individuals between 60-80 years of age will receive BCG vaccination while 725 individuals will be controls without vaccination Study duration: 6 months/participant. Enrolment at each site will be over: 4 months. Each participant will be followed for 6 months post vaccination. Primary Outcome Measures: During the study period (6-months), Proportion of individuals receiving the BCG vaccination who are asymptomatic but become PCR-positive or seroconvert during the 6-month of study period. Proportion of patients with development of COVID-19 disease (either PCR-positive or seroconvert with symptoms) during the study period. Proportion of patients with Severe COVID-19 disease and death due to Covid-19 disease
详细描述
Recruitment area: Under the Lockdown 2.0, the country has been classified into three key zones-Red, Orange and Green (26). These zones will support the cluster containment plan announced by the government, while opening up the rest of the places.
Green Zone: Places which have so far not reported even a single COVID-19 positive case will be declared as Green Zone under Government's new plan. This means nearly 400+ districts of India might qualify to be tagged as Green Zone.
Orange Zone: Orange zone may see opening of limited public transport and also allow exemptions for essential services personnel and farming and harvest activity for the ongoing season. Orange zone will have less than 15 cases of COVID-19.
Red Zone: A district or cluster declared as a red zone, will see severe restrictions with zero or no activity allowed. Typical understanding is that any place with more than 15 COVID-19 positive cases can be declared as a red zone. Investigators will include the Red & Orange zones of Delhi, Madhya Pradesh, Maharashtra, Gujarat, Tamilnadu, Rajasthan and other interested states for this study.
Recruitment methods: Participants would be recruited through (i) information presented in community organizations, hospitals, colleges and other institutions to the general public. (ii) From a line list prepared of adults above the age of 60 years from Census data for the hotspot areas. (iii) Participants will also be recruited by use of an advertisement +/- registration form formally approved by the ethics committee(s) and distributed or posted in the
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 60 years of age or older (<100 years) with general good health, as confirmed by history and physical examination.
- •No known history of HIV or on immunosuppressive drugs for malignancy or transplant
- •Provide a signed and dated informed consent form
排除标准
- •Positive for SARS-Cov2 infection
- •Known HIV or other immune-suppressive treatments for malignancy or transplant
- •Recently diagnosed as TB or currently on anti-TB treatment or anti-psychiatric medications
- •Has any BCG vaccine contraindication
- •H/o of previous administration of experimental MTB vaccines within the past 6 months.
- •Sick and moribund individuals with Karnofsky score <50
- •Elderly individuals with or without co-morbid conditions like Diabetes mellitus, or Hypertension or Hyperlipidemia will be considered for this study, if they are on regular treatment.
结局指标
主要结局
Mortality due to COVID-19 disease
时间窗: 6 months from study start date
Number of deaths due to COVID-19 disease
次要结局
- Hospital admission and ICU admission due to Covid-19, Severity of Covid-19 (mild, moderate or severe), Hospital admission due to other respiratory febrile illness, immunological outcomes in the sub study(10 months from study start date)