COVID-19 Prevention Trial: Effect of Prophylactic Use of TAFFIX™ on Infection Rate by SARS-CoV-2 Virus (COVID-19).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Nasus Pharma
- 入组人数
- 693
- 试验地点
- 1
- 主要终点
- COVID-19 new cases
研究概览
简要总结
TAFFIX is a nasal powder spray that immediately creates a protective acidic barrier on the nasal mucosa against infection by inhaled viruses. The protective barrier lasts 5 hours.
TAFFIX is approved as a medical device in Israel, intended for use to block inhaled viruses within the nasal cavity. In Europe, it is registered as a medical device indicated for use as a protective mechanical barrier against allergens and viruses (e.g., SARS-CoV-2) within the nasal cavity.
TAFFIX is used as additional safety mean together with masks, hygiene, and social distancing.
The study rationale is to evaluate whether daily use of TaffiX™ as prophylaxis will reduce the rate of SARS- CoV-2 infection and other upper respiratory infections, compared to the placebo control rate.
详细描述
Study Design:
This is a 2 arms, Randomized, double blind, placebo controlled clinical trial.
Study population:
Subjects who, were not diagnosed with COVID-19 previously to their best knowledge and according to COVID-19 antibody test.
Were not vaccinated yet against COVID-19 and will not be vaccinated during their participating in the study.
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
- Single (Outcomes Assessor)
盲法说明
Double blind.
入排标准
- 年龄范围
- 12 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects 12 yr and older who had not previously been infected with COVID-19 to the best of their knowledge.
- •Were not vaccinated yet against COVID-19 and will not be vaccinated during the study (if they decide to get the vaccine during the study they will be excluded a week later).
- •Negative serology rapid test to COVID-
- •Be informed of the nature of the study and the procedures and sign an informed consent form.
- •Willing and able to adhere to Protocol requirements.
- •If female of childbearing potential, agree to use an acceptable method of birth control or be surgically sterile, and have a negative pregnancy test.
排除标准
- •Known sensitivity to citric acid and/or sodium citrate and /or benzalkonium chloride and /or Hydroxypropylmethylcellulose (HPMC) or lactose (does not mean diagnosed lactose intolerance in food).
- •Females who are pregnant or are lactating as reported by the subject.
结局指标
主要结局
COVID-19 new cases
时间窗: Through study completion, 6 weeks
symptoms score (Fever; Cough; Rigors; Myalgia; Headache; Vomiting or Diarrhea; Shortness of breath; Breathing difficulties; New olfactory and taste disorder(s); Runny or stuffy nose; Sore throat) as reported in Bi-weekly questionnaires, PCR or antigen test at symptomatic subjects, serology test at end of the study.
次要结局
- The safety and tolerability of the study device.(Through study completion, 6 weeks.)