protocolSection identificationModule nctId: NCT06278324, orgStudyIdInfo id: C1736, secondaryIdInfos id: 2023-A02286-39, type: REGISTRY, domain: ANSM, briefTitle: Effectiveness of a Nasal Spray on Viral Respiratory Infections, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-26, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: CEN Biotech, class: INDUSTRY, collaborators name: Urgo Research, Innovation & Development, descriptionModule briefSummary: There is no cure for cold or flu, most people recover in about within two weeks. Paracetamol may be used to reduce aches or treat fever, headache, or body aches. Antiviral solutions ranging from simple universal saline solutions to novel compounds have been proposed to provide a temporary barrier to prevent viral infection and propagation.The nasal spray "Humer Stop Virus" is indicated in patients presented with early symptoms of viral respiratory infection. This spray forms a protective barrier in the nasal mucosa which is the main entry of the upper air respiratory system viruses. The spray traps the viruses and helps the organism to eliminate them before they multiply themselves.This clinical investigation is conducted to assess the performance, clinical benefit and safety of this nasal spray in patients with early symptoms of acute respiratory disease whether or not infection is related to common cold, flu or COVID virus. Indeed, presence of early symptoms of acute respiratory infection does not always imply viral infectionAntigen self-tests are available to confirm viral infection with flu viruses or severe acute respiratory syndrome (SARS-CoV-2). However, influenza and other winter viruses are not systematically searched for in general population, because this is of neither collective nor individual interest. To be as pragmatic as possible, we chose to assess performance and safety of the nasal spray on intended users in real conditions. Patients with early symptoms of cold, flu or COVID, are enrolled regardless their PCR test positivity confirming viral infection at the time of enrollment. For study needs, the primary endpoint, which aims to assess the performance of the nasal spray in terms of stopping the viral infection, is assessed in a subgroup of patients with a positive PCR test with flu, COVID or common cold virus in the nasal sample collected at enrollment., conditionsModule conditions: Acute Respiratory Tract Infection, conditions: Flu, Human, conditions: COVID-19, conditions: Common Cold, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Controlled Trial, parallel arms (1:1 allocation ratio), single center, with a blind assessment for primary outcome, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Blinded assessment of viral load analyses, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Nasal Spray HSV Treatment, outcomesModule primaryOutcomes measure: Performance of nasal spray in eliminating viruses, secondaryOutcomes measure: Changes from baseline in viral load, secondaryOutcomes measure: Rate of patients cleared from viral infection, secondaryOutcomes measure: Rate of patients with improved viral infection, secondaryOutcomes measure: Rate of patients with worsening viral infection, secondaryOutcomes measure: Rate of patients with new viral infection, secondaryOutcomes measure: Changes in symptom severity, secondaryOutcomes measure: Duration of illness, secondaryOutcomes measure: Time to clinical improvement of the symptoms, secondaryOutcomes measure: Adverse event occurence, otherOutcomes measure: Patient opinion of nasal spray, otherOutcomes measure: Nasal spray safety, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 84 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cen Experimental, status: RECRUITING, city: Dijon, state: Burgundy, zip: 21000, country: France, contacts name: Amandine FRY, role: CONTACT, phone: 0033380680513, email: amandine.fry@groupecen.com, contacts name: Carole PERRIN, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.31667, lon: 5.01667, hasResults: False