Effectiveness of a Nasal Spray on Viral Respiratory Infections

NCT06278324 | Completed

• 2 other identifiers: C17362023-A02286-39
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Respiratory Tract Infection; Flu, Human; COVID-19; Common Cold

Keywords

Nasal spray

Outcome Measures

Primary Outcomes (1)

• Performance of nasal spray in eliminating viruses

  0-84 hours areas under the curve (AUC) of viral load in patients with a positive virus infection at enrollment. Positive viral infection means that at least one of the following respiratory viruses has been detected in nasal sample collected at enrollment: SARS-CoV-2, Influenza A virus, Influenza B virus, Respiratory syncytial virus (RSV) A/B, Metapneumovirus (MPV), Adenovirus A/B/C/D/E/F, Rhinovirus A/B/C, Parainfluenza virus 1/2/3/4, Bocavirus 1/2/3/4, Coronavirus 229E, Coronavirus NL63, Coronavirus OC43 Virus load is measured using Reverse Transcriptase quantitative polymerase chain reaction (RT-qPCR).

  84 hours

Secondary Outcomes (9)

• Changes from baseline in viral load

  24 hours and 84 hours

• Rate of patients cleared from viral infection

  24 hours and 84 hours

• Rate of patients with improved viral infection

  24 hours and 84 hours

• Rate of patients with worsening viral infection

  24 hours and 84 hours

• Rate of patients with new viral infection

  24 hours and 84 hours

Other Outcomes (2)

• Patient opinion of nasal spray

  day 8

• Nasal spray safety

  Day 8

Study Arms (2)

Nasal spray Humer Stop Virus (HSV)

EXPERIMENTAL

Patients treated with the nasal spray Humer Stop Virus (HSV) . Analgesics and antipyretics are authorized. Any other nasal spray, nasal cleansing (saline, water or other), and inhalation are prohibited

Device: Nasal Spray HSV Treatment

Control

NO INTERVENTION

Analgesics and antipyretics are authorized. Any nasal spray, nasal cleansing (saline, water or other), and inhalation are prohibited

Interventions

Nasal Spray HSV Treatment DEVICE

Nasal treatment with the nasal spray Humer Stop Virus for 7 days, 2-3 puffs per nostril, 3-4 per day, space applications 4 hours apart.

Nasal spray Humer Stop Virus (HSV)

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• CEN Biotech: lead
• Urgo Research, Innovation & Development: collaborator

Study Sites (1)

Cen Experimental

Dijon, Burgundy, 21000, France

Location

MeSH Terms

Conditions

Influenza, Human; COVID-19; Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases; Picornaviridae Infections

Study Officials

• Christelle FOUCHER

  Urgo Research, Innovation & Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded assessment of viral load analyses
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial, parallel arms (1:1 allocation ratio), single center, with a blind assessment for primary outcome

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 26, 2024
• Study Start: January 26, 2024
• Primary Completion: April 16, 2025
• Study Completion: May 16, 2025
• Last Updated: August 7, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)