Study on the performance and safety of Sentinox in the prevention of acute respiratory infections
- Conditions
- Acute respiratory infectionsRespiratory
- Registration Number
- ISRCTN14096939
- Lead Sponsor
- Applied Pharma Research (Switzerland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 144
1. Informed consent form (ICF) signed
2. Aged between 18 and 64 years old at the time of the signature of ICF
3. 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
1. Reporting of any symptoms of acute respiratory infections in the 15 days preceding the Visit 1
2. Reporting the assumption of any drugs, among antiviral or antibacterial therapies, that may interfere with the study results in the 15 days preceding Visit 1
3. Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease)
4. Immune system illnesses
5. Known drug and/or alcohol abuse
6. Individuals who are cognitively impaired and/or who are unable to give informed consent
7. Ongoing or prior participation in any other clinical trial of an experimental treatment within 30 days from Visit 1
8. Concurrent or planned treatment with other agents with actual or possible direct antiviral/antibacterial activity
9. Positive pregnancy test or breastfeeding woman
10. Known hypersensitivity to the study treatment, its metabolites, or formulation excipient
11. History of severe drug and/or food allergies
12) Any condition that, in the opinion of the Investigator, would complicate or compromise the study or well-being of the subject
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method