Acute Respiratory Tract InfectionNCT06278324
Effectiveness of a Nasal Spray on Viral Respiratory Infections
A study testing Nasal Spray HSV Treatment in people with Acute Respiratory Tract Infection and Flu, Human, run by CEN Biotech at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Acute Respiratory Tract Infection, Flu, Human, COVID-19
- What is being tested?
- Nasal Spray HSV Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jan 2024to 16 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
Patients are recruited at the study site by the principal investigator, who gives a brief presentation of the study. Eligible, informed patients who sign a consent form are included and randomized.
All patients undergo three nasal swabs: at the time of enrolment, then 24 hours and 84 hours later, and complete a daily questionnaire on a secure mobile application dedicated to patient reported outcomes to assess their symptoms and provide information on any analgesic or antipyretic medication they may have been taking.
Patients randomized to the intervention group are asked to use the nasal spray as recommended and to report any difficulties with the device.
A final visit is organized on day 8 at the investigation center under the supervision of the investigator.
- Conditions
- Acute Respiratory Tract Infection, Flu, Human, COVID-19, Common Cold
- Being tested
- Nasal Spray HSV Treatment
- Keywords
- Nasal spray
- Medical subject headings
- Influenza, Human, COVID-19, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal Spray HSV TreatmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 84 hours
Secondary outcomes (9)
Changes from baseline in viral load
Percentage reduction in viral load in patients with a positive virus infection at enrollment.
Virus load is measured as described in primary outcome.
Measured: 24 hours and 84 hours
Rate of patients cleared from viral infection
Percentage of patients with a positive virus infection at enrollment totally cleared from viral infection, meaning with negative viral load.
Virus load is measured as described in primary outcome.
Measured: 24 hours and 84 hours
Rate of patients with improved viral infection
Percentage of patients with a positive virus infection at enrollment who present lower viral load.
Virus load is measured as described in primary outcome.
Measured: 24 hours and 84 hours
Rate of patients with worsening viral infection
Percentage of patients with a positive virus infection at enrollment who present higher viral load.
Virus load is measured as described in primary outcome.
Measured: 24 hours and 84 hours
Rate of patients with new viral infection
Percentage of patients with a virus infection not present at enrollment. Virus load is measured as described in primary outcome.
Measured: 24 hours and 84 hours
Changes in symptom severity
Symptom severity is assessed using the Total Symptom Score, which consists of 7 questions, each rated on a 4 point-Likert scale (none = 0, mild = 1, moderate = 2, severe = 3).
The score ranges from 0 to 28.
Measured: day 1, day 2, day 3, day 4, day 5, day 6, day 7
Duration of illness
Number of days between onset of symptoms and last day before first day with Total Symptom Score returns to 0.
Total Symptom Score is measured as described in outcome 7
Measured: day 1, day 2, day 3, day 4, day 5, day 6, day 7
Time to clinical improvement of the symptoms
Number of days between day 1 and the first day the patient reports "much improved" or "very much improved," items of the 7 point-Likert scale assessing the patient's global impression of improvement
Measured: day 1, day 2, day 3, day 4, day 5, day 6, day 7
Adverse event occurence
Percentage of patients with adverse events between consent signature and final visit.
Measured: day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start26 Jan 2024
- Primary completion16 Apr 2025
- Study completion16 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial, parallel arms (1:1 allocation ratio), single center, with a blind assessment for primary outcome
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEN Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Urgo Research, Innovation & Development
- Responsible party
- Sponsor
- Investigators
- Christelle FOUCHER, Study director, Urgo Research, Innovation & Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278324
- Sponsor's protocol ID
- C1736
- Other IDs
- 2023-A02286-39
- Status last verified
- Aug 2024
- First submitted
- 19 Feb 2024
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06278324
- Acronym / sponsor ID
- C1736
- Conditions
- Acute Respiratory Tract Infection, Flu, Human, COVID-19, Common Cold
- Keywords
- Nasal spray
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- CEN BiotechIndustry (pharma, biotech, devices)
- Collaborators
- Urgo Research, Innovation & Development
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 16 Apr 2025 (actual)
- Study completion
- 16 May 2025 (actual)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients are recruited at the study site by the principal investigator, who gives a brief presentation of the study. Eligible, informed patients who sign a consent form are included and randomized.
All patients undergo three nasal swabs: at the time of enrolment, then 24 hours and 84 hours later, and complete a daily questionnaire on a secure mobile application dedicated to patient reported outcomes to assess their symptoms and provide information on any analgesic or antipyretic medication they may have been taking.
Patients randomized to the intervention group are asked to use the nasal spray as recommended and to report any difficulties with the device.
A final visit is organized on day 8 at the investigation center under the supervision of the investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial, parallel arms (1:1 allocation ratio), single center, with a blind assessment for primary outcome
| Arm | Type | Receives |
|---|---|---|
| Nasal spray Humer Stop Virus (HSV) | Experimental | Device: Nasal Spray HSV TreatmentPatients 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 |
| Control | No intervention | –Analgesics and antipyretics are authorized. Any nasal spray, nasal cleansing (saline, water or other), and inhalation are prohibited |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal Spray HSV TreatmentNasal 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. | Device | Nasal spray Humer Stop Virus (HSV) |
Primary outcome
Performance of nasal spray in eliminating viruses
Time frame: 84 hours
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).
9 secondary outcomes
Changes from baseline in viral load
Time frame: 24 hours and 84 hours
Rate of patients cleared from viral infection
Time frame: 24 hours and 84 hours
Rate of patients with improved viral infection
Time frame: 24 hours and 84 hours
Rate of patients with worsening viral infection
Time frame: 24 hours and 84 hours
Rate of patients with new viral infection
Time frame: 24 hours and 84 hours
Changes in symptom severity
Time frame: day 1, day 2, day 3, day 4, day 5, day 6, day 7
Duration of illness
Time frame: day 1, day 2, day 3, day 4, day 5, day 6, day 7
Time to clinical improvement of the symptoms
Time frame: day 1, day 2, day 3, day 4, day 5, day 6, day 7
Adverse event occurence
Time frame: day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christelle FOUCHER study director
Urgo Research, Innovation & Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal Spray HSV Treatment in people with Acute Respiratory Tract Infection and Flu, Human, run by CEN Biotech at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of nasal spray in eliminating viruses (time frame: 84 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.