Effectiveness of a Nasal Spray on Viral Respiratory Infections

Launched by CEN BIOTECH · Feb 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a nasal spray called "Humer Stop Virus" for people who have early symptoms of viral respiratory infections, such as the common cold, flu, or COVID-19. The spray works by creating a protective barrier in the nose that helps trap viruses, potentially preventing them from multiplying and causing more illness. The researchers want to find out how well the nasal spray works, how safe it is, and if it can help people feel better.

To participate in the study, you should be between the ages of 65 and 80 and have mild to moderate symptoms of a respiratory infection that started less than two days ago. You also need to have a smartphone to complete questionnaires about your health as part of the trial. While the study is open to anyone with early symptoms, certain conditions or treatments may prevent you from joining, such as having a serious nasal blockage or being part of another clinical trial. If you qualify, you can expect to receive the nasal spray and be monitored for its effects on your symptoms.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • With early symptoms of respiratory infection (onset less than 48 hours before inclusion) of mild to moderate intensity (TSS ≥ 2 and \< 9).
• • Having a mobile phone allowing using the patient reported outcome App. (NursTrial®).
• • Patient able to understand and comply with protocol requirements and instructions, including answering a questionnaire on a mobile phone, as required by protocol.
• • Signed informed consent.
• • Affiliated to a French Health insurance scheme.
• Exclusion Criteria:
• • Concomitant disease or infection that could interfere with participation in the study: acute ear, nose, and throat and respiratory tract disease other than the common cold, flu or COVID (e.g., tonsillitis, otitis, bronchitis) and chronic sinusitis or allergic rhinitis, or other reasons for nasal obstruction and other past or present conditions and treatments that could influence symptom scores.
• • Severe nasal septum deviation or other conditions that could cause nasal obstruction such as the presence of nasal polyps.
• • Known or suspected intolerance or hypersensitivity, including history of allergies, to any component investigational device material, any history of drug hypersensitivity.
• • Concomitant treatment that might impair the trial results (i.e., decongestants, local anesthetics, topical corticosteroids, saline solution) during the seven days prior to inclusion.
• • Smokers.
• • Have a condition or is taking a medication that the Investigator and/or designee believes could jeopardize the safety of the subject, would interfere with the evaluation, or confound the interpretation of the study results.
• • Non-compliant or may not respect the constraints imposed by the protocol.
• • Enrolled in another clinical trial or being in a period of exclusion from a previous clinical trial;
• • Woman of childbearing age (except menopausal, hysterectomised, sterilized) not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant, or condoms).
• • Person belonging to a population referred to in articles 64 (incapacitated subjects), 65 (minors), 66 (pregnant or breastfeeding women), 67 (persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial decision) and 68 (patients in emergency) of the Medical Device Regulation.