ACTRN12620000707965撤回3 期
A Multicenter, Phase III, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy of the recombinant BCG VPM1002 on the Incidence or Disease Severity of SARS-COV-2/COVID-19 Among High-Risk Participants in Australia
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 3,468
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Male or Female participants >/= 18 years of age at high-risk of SARS-CoV-2/COVID-19 infection
- •2. Participants with high-risk of infection to COVID-19 cases defined as:
- •Health care workers (physicians, nurses, paramedical staff) working in direct contact with COVID-19 patients
- •Other high-risk participants who are aged >/= 65 years or aged >/= 18 years with co-morbidities such as:
- •Insulin dependent or non-insulin dependent diabetes mellitus
- •Hypertension
- •Past history of completed acute myocardial infarction
- •Cardiac failure of NYHA class 2 and above
- •Rheumatic heart disease
- •Chronic obstructive pulmonary disease, bronchiectasis or emphysema
- •Chronic suppurative lung disease
- •Cystic fibrosis
- •Pulmonary fibrosis
- •3. Negative screening for SARS-CoV-2 infection (using a validated and approved PCR or serology test method) at time of consent
- •4. Capable of giving informed consent
排除标准
- •1. Known active Mycobacterium tuberculosis disease
- •2. Fever (greater than or equal to 38 ºC) or any other respiratory symptoms/illnesses within the past 14 days
- •3. BCG vaccination in the previous 12 months
- •4. Has any BCG vaccine contraindication/s
- •5. Confirmed existing or past COVID-19 infection by PCR or serology testing methods with or without symptoms
- •6. Pregnant or breastfeeding women
- •7. Women of child-bearing potential not agreeing to use adequate contraception
- •8. Current active viral or bacterial infection
- •9. Expected vaccination during the study period, independently of the type of vaccination
- •10. Severely immunocompromised participants. This exclusion category comprises
- •a) participants with known infection by the HIV;
- •b) participants with solid organ transplantation;
- •c) participants with bone marrow transplantation;
- •d) participants under chemotherapy/radiotherapy;
- •e) participants with primary immunodeficiency;
- •f) treatment with any anticytokine therapies.
- •g) treatment with oral or intravenous steroids defined as daily doses of 10mg prednisolone or equivalent for longer than 3 months from the time of screening, or probable use of oral or intravenous steroids in the following four weeks
- •11. Active solid or non-solid malignancy or lymphoma within the prior two years
- •12. Individuals known to be hypersensitive to any component of the vaccine
- •13. Eczema or other significant skin lesion or infection at the site/s of injection.
- •14. Any other medical condition which in the opinion of the investigator may affect the participant’s safety or study participation and conduct.
研究者
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