Scheme of Primary Prevention of Infection by COVID-19, in Workers: Phase II Controlled Clinical Trial, to be Carried Out in Medellín-Antioquia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Seroconversion of IgM for COVID-19.
研究概览
简要总结
Introduction: The SARS Co-2 contagious rate is high (Ro: 2.0-3.0). The infection is aggressive with high pathogenicity. Global confinement impacts all social and economic fields of human activity. Clinical behavior exceeds the capabilities of public health care. With the initial information on the pandemic, it is estimated that 20% of health personnel in direct contact with patients can acquire the disease, despite preventive self-care. The molecular relationship of COVID-19 with the subject's ACE2 protein encourages the virus to enter the host cell, and initiates replication and the immune response, causing an imbalance generating an immunological storm of cytokines, with serious damage to the host.
Objective: It is proposed to supply a combined scheme of two compounds by oropharyngeal spray that captures the virus before entering the target cell and orally administer immunomodulatory compounds that regulate the inflammatory response released by the virus, in order to improve the antiviral response.
Methodology: A controlled, parallel design, triple-blind, phase II clinical trial will be conducted with two study groups to compare the active compounds (oropharyngeal spray and emulsion) with placebo.
Discussion: With the application of the combined scheme of two compounds, a 75% reduction in infection is expected for workers in direct contact with COVID patients.
详细描述
RESEARCH QUESTION: Can the oropharyngeal spray of a viral blocking compound in conjunction with the provision of an immunostimulant emulsion, reduce the infection proportion by 2/3
ACTIVE PRINCIPLE Intervention 1. BlockACE2® spray, antimicrobial and antiviral liquid solution for mouth spray, composed of 3 natural bioactive substances proven to be used in humans, which present molecular structures homologous to the native receptor of the virus. It contains binding peptides that resemble the ACE2 receptor, which bind to viral fractions, and acts as soluble scavengers of the virus at the entrance gate, upper respiratory tract, or oropharyngeal region, preventing its entry into the target cell and decreasing the amount of virus that enters the body; consequently, they reduce their ability to generate damage.
BlockACE2® Defense, food for oral administration in the form of an emulsion with 8 bioactive components that have shown modulation of the inflammatory response. Contains natural oils, Vitamin B6, Vitamin C, Vitamin E, Vitamin D3 100 SD / S, and minerals; key micronutrients that are not normally obtained through a traditional diet. These nutrients are immunostimulants with proven capacity to enhance the cellular response against viruses, anti-inflammatory, antioxidant, and chemoprotective activity, stimulating the production of interferon I; and as a whole, they prevent the generation of an excessive immune activation process, known as an "immune storm" mediated by pro-inflammatory cytokines.
Intervention 2, Placebo:
Preparations without active components in the pharmaceutical form of the above (Intervention 1 and Intervention 2). They will be presented with the same physical characteristics such as size, shape, color, taste, smell, consistency, printed signs, weight, surface finish, internal and external; in order to guarantee the principle of masking.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Once the participant has given its informed consent, and the research team has verified the fulfillment of the inclusion criteria, the prospect receives a text message, to be directed to the pharmaceutical service. The numbered scheme will be dispensed with the code of the intervention, following the order from the allocation listing, provided by the CTCC. The head of the pharmaceutical service will register the date and time of the first dose. He will provide indications for the use, handling, and conservation of the products. Warning signs and symptoms and instructions for communication with the research team to address any concerns the subject may have will be reviewed. He will remind the subject to avoid its damage or loss. He will give the participant instructions to return the container and surpluses of the products at the end of the trial (day 30), he will point out that they are for personal use only and that they cannot be shared.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 60 years.
- •Health care worker in the front line of care of suspected or confirmed cases of COVID-
- •Negative IgM antibodies.
排除标准
- •Being a participant in another trial with another drug.
- •Temperature above 38ºC.
- •Having cohabited in the past 15 days with a person diagnosed with CoV-
- •Active o past smoker.
- •Known hypersensitivity to drugs or food.
- •History of respiratory disease.
- •Underlying diseases (Hypertension, cancer, diabetes, cardiovascular disease, leukopenia).
- •Signs or symptoms of CoV-19 infection: cough, dyspnea, myalgias.
结局指标
主要结局
Seroconversion of IgM for COVID-19.
时间窗: 1 month
Seroconversion of IgM for COVID-19. Result of positive IgM antibodies: A previously scheduled closure visit will be conducted, the trial product will be interrupted if a case is classified as severe-critical, and clinical follow up will be continued as planned. As protocols by the Health Ministry dictate, cases will be confirmed with a PCR-RT test, for the diagnosis of COVID-19. The result of the test will be requested to document the outcome.
次要结局
- Seroconversion of IgG for COVID-19.(through study completion, 45 days)
研究者
Beatriz Aristizabal
Beatriz H Aristizabal B, MsC immunology, MsC Medical Genetics, PhD Molecular Biolgy, Scientific director of Unidad de Investigación Genética Molecular
Unidad de Investigación Genética Molecular