Post-market, Randomized and Controlled Clinical Study to Assess the Performance and Safety of Sentinox in the Prevention of Acute Respiratory Infections
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Performance of self-administered Sentinox intranasal spray in preventing ARI caused by at least one respiratory virus
研究概览
简要总结
This is a post market, single-center, randomized, controlled, clinical study to assessTo evaluate the performance of self-administered Sentinox intranasal spray in preventing ARI caused by at least one respiratory virus
详细描述
The study will consist of:
- A screening visit (Visit 0, on-site) to sign the informed consent form (ICF). The operator will:
o review the inclusion/exclusion criteria
o record the medical history, demographic data and concomitant medications (CMs), including previous anti-influenza, anti-COVID-19 and anti-pneumococcal vaccinations
-
A randomization visit (Visit 1, on-site) to start the surveillance period. As soon as an increase in the regional epidemiological curve of ARI is observed, screened subjects will be invited for Visit 1. At Visit 1 the operator will:
-
check that the inclusion/exclusion criteria are still met, to confirm eligibility
-
confirm the medical history and the concomitant medications including previous anti-influenza, anti-COVID-19 and anti-pneumococcal vaccinations
-
record the result of the pregnancy testing
-
randomize with a 1:1 ratio in one of 2 trial Groups: - Group A: treatment with Investigational Medical Device (IMD) performed 3 times/day for 21 days at 8 am, 2 pm and 8 pm
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 63 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ICF signed.
- •Males and females aged ≥ 18 years and <64 years at the time of the signature of the ICF.
- •Subjects who are willing to comply with the requirements of the study protocol, attend scheduled visits and calls for the duration of the study by telephone contact and install the Mobile App to use the e-diary.
排除标准
- •Reporting of any symptoms of ARI in the 15 days preceding the Visit
- •Reporting the intake of any drugs, among antiviral or antibacterial therapies, that may interfere with the study results in the 15 days preceding the Visit
- •Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease).
- •Immune system illnesses.
- •Known drug and/or alcohol abuse.
- •Individuals who are cognitively impaired and/or who are unable to give informed consent.
- •Ongoing or prior participation in any other clinical trial of an experimental treatment within 30 days from Visit
- •Concurrent or planned treatment with other agents with actual or possible direct antiviral/antibacterial activity.
- •Positive pregnancy test or breastfeeding woman.
- •Known hypersensitivity to the study treatment, its metabolites, or formulation excipient.
- •History of severe drug and / or food allergies.
- •Any condition that, in the opinion of the Investigator, would complicate or compromise the study or well-being of the Subject
结局指标
主要结局
Performance of self-administered Sentinox intranasal spray in preventing ARI caused by at least one respiratory virus
时间窗: Daily for a surveillance 21-days period
Measure the proportion of patients with at least one symptoms of ARI (i.e., cough, sore throat, shortness of breath, coryza, as described in the European Commission guideline on relevant case definitions of communicable diseases \[Commission Implementing Decision (EU) 2018/945 of 22 June 2018\]) and confirmed by positive swab for at least 1 virus.
次要结局
- Performance of Sentinox in preventing ARI caused by different respiratory viruses(Daily for a surveillance 21-days period)
- Subjects' satisfaction of self -administering Sentinox(Daily for a surveillance 21-days period)
- Performance of Sentinox intranasal administration against bacterial infection(Daily for a surveillance 21-days period)
- Performance of Sentinox in preventing clinically defined ARI without microbiological confirmation(Daily for a surveillance 21-days period)
- Tolerability and safety of Sentinox(Daily for a surveillance 21-days period)