Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial on the Efficacy of BACMUNE (MV130) in the Prevention of Disease Due to SARS-CoV-2 Infection in Healthcare Personnel
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 6
- 主要终点
- Severity of COVID-19
研究概览
简要总结
The purpose of this trial is to assess the effect of immunotherapy with the bacterial preparation MV130 on the spread and course of SARS-CoV-2 infection in highly exposed subjets, as is the case with healthcare personnel.
详细描述
This is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy of BACMUNE (MV130) in the prevention of disease due to SARS-VoC-2 infection in healthcare personnel
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, Care Provider, Investigator)
盲法说明
Double blind placebo control
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Health personnel who are or have been in contact with patients with disease due to SARS-COV-2 infection within the last 14 days before randomization.
- •Negative result for test against COVID-
- •Subjects who have given informed consent.
- •Men or women aged between 18 and 65 years, both included.
- •Subjects who have a smartphone where they can load an APP for monitoring the symptoms.
排除标准
- •Subjects who are participating in another clinical trial.
- •Subjects who are unable to offer cooperation and/or have serious psychiatric disorders.
- •Subjects who are allergic to any of the compounds included into MV
- •Subjects who present contraindications to any of the components of BACMUNE (MV130).
- •Subjects who are not able to comply with the dosage regimen.
- •Subjects with immunodeficiencies.
- •Subjects with malignancy involving the bone marrow or lymphoid systems.
- •Pregnant or suspected pregnant women and breastfeeding women.
- •Subjects in medical treatment that affects the response of the immune system. It includes corticosteroids (equal to or more than 20 mg for more than 2 weeks), immunosuppressants, biological agents (such as anti TNF-alpha monoclonal antibodies, etc.).
- •Subjects with HIV.
- •Subjects under treatment with metformin.
- •Subjects treated with Sertraline.
- •Subjects treated with statins.
结局指标
主要结局
Severity of COVID-19
时间窗: 60 days
Incidence of severe COVID-19, defined by CURB \> 2 and/or death
Incidence of subjects with COVID-19
时间窗: 60 days
Incidence of subjects with COVID-19, defined by the presence of: * Fever * Any of the respiratory signs and/or symptoms: cough, dyspnea, respiratory failure, runny nose/nasal obstruction. * Positive test for SARS-COV-2 (PCR o serology)
次要结局
- Subjects with symptoms(60 days)
- Elapsed time until hospitalization(60 days)
- Elapsed time until death not related to COVID-19(60 days)
- Seroconversion to SARS-CoV-2(60 days)
- Hospital admission due to COVID-19(60 days)
- Admission to an intensive care unit due to COVID-19(60 days)
- Elapsed time until admission into an care unit for COVID-19(60 days)