Randomized, Controlled, Double-Blind Proof of Concept Trial Assessing the Efficacy and Safety of BioBlock® Intranasally Administered Virus-Neutralizing Bovine Colostrum Nasal Spray in Preventing of COVID-19 Infection in Healthy Volunteer Individuals
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- effectiveness of the BioBlock®
研究概览
简要总结
This is a proof-of-concept double-blind cluster randomized (1:1) parallel study. The randomization unit is healthy volunteers who have no symptoms of COVID-19 at the start of the study and have not been infected with the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) virus in the past 90 days. The selected individuals are randomly grouped in either the experimental group (individuals using the BioBlock® antiviral nasal spray immediately after waking up in the morning and thereafter once every 4 hours and so for 28 days) or the control group (placebo is used by individuals immediately after waking up in the morning and thereafter once every 4 hours and so for 28 days).
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
- Double (Participant, Care Provider)
盲法说明
The study and control sprays can only be distinguished by serial numbers, the content of which is not known by the study staff or the subjects.
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
- •Agree to participate in the study Age: 18-60 years (based on the age group with the best digital competence).
排除标准
- •Pregnancy
- •age less than 18 years and over 60 years,
- •a person identified with SARS-CoV-2 infection at the beginning of the study,
- •a person with symptoms of SARS-CoV-2 infection,
- •a person who has recovered from Covid-19 in the last 3 months,
- •a person who regularly takes medicinal products administered by inhalation by nasal and oropharyngeal means.
- •patients with known allergies to BioBlock® components and milk proteins
- •BioBlock ingredients are: Purified water • Bovine colostrum SARS-CoV-2 antibodies • Phosphate buffer: DPBS (without Ca and Mg salts) • Viscosity-enhancing agents: PEG400, PVP K30 • Preservative: sodium benzoate • Acidity regulator: citric acid • Mucous membrane moisturizing agent: glycerol • Potassium chloride - buffer solution component • Potassium dihydrogen phosphate - buffer solution component • Sodium chloride - buffer solution component • Disodium phosphate - buffer solution component
- •BioBlock® use in the last 24 hours If the subject has taken BioBlock® during the last day and there are no other criteria for exclusion from the study, then the subject is suitable for inclusion in the study from the next day
研究组 & 干预措施
experimental group
Individuals using the BioBlock® antiviral nasal spray immediately after waking up in the morning and thereafter once every 4 hours and so for 28 days.
干预措施: BioBlock® antiviral nasal spray (Biological)
control group
Placebo is used by individuals immediately after waking up in the morning and thereafter once every 4 hours and so for 28 days.
干预措施: BioBlock® antiviral nasal spray (Biological)
结局指标
主要结局
effectiveness of the BioBlock®
时间窗: 3 months
BioBlock® nasal spray users are less likely to contract the virus than placebo users. BioBlock effectiveness will be estimated using Cox regression (BPE = 1 - hazard ratio \[HR\]) or Poisson regression (BPE = 1 - rate ratio \[RR\]).
次要结局
- safety of the BioBlock® virus neutralizing nasal spray(6 months)