Nasal spray for treating viral respiratory infections
Performance and Safety Assessment of HUMER STOP VIRUS Nasal Spray in Adults With Early Symptoms of Viral Respiratory Infection (COVID-19, Flu, Common Cold): an Open-label Randomized Controlled Study
This study tests if a nasal spray called 'Humer Stop Virus' can help people with early symptoms of viral infections like the cold, flu, or COVID-19 feel better compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 84 Years |
| Sex | All |
| Sponsor | CEN Biotech Industry-sponsored |
| Locations | 1 site (Dijon, Burgundy) |
| Trial ID | NCT06278324 on ClinicalTrials.gov |
What this trial studies
This clinical investigation evaluates the effectiveness and safety of a nasal spray called 'Humer Stop Virus' in patients exhibiting early symptoms of viral respiratory infections, including the common cold, flu, and COVID-19. Participants will be randomized to receive either the nasal spray or standard care, and their symptoms will be monitored through daily questionnaires and nasal swabs over an 8-day period. The nasal spray aims to create a protective barrier in the nasal mucosa to trap viruses and prevent their multiplication.
Who should consider this trial
Good fit: Ideal candidates are individuals with early symptoms of respiratory infection that have started within the last 48 hours and are mild to moderate in intensity.
Not a fit: Patients with severe nasal obstruction or other significant respiratory conditions may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this nasal spray could provide a new method for reducing the severity and duration of viral respiratory infections.
How similar studies have performed: While similar approaches have been explored, the specific use of this nasal spray for viral respiratory infections is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Dijon, Burgundy
- Cen Experimental — Dijon, Burgundy, France (Recruiting)
Study contacts
- Study coordinator: Christine JUHEL, PhD
- Email: christine.juhel@groupecen.com
- Phone: 0033380680511
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.