An interventional study of Nasal Spray HSV Treatment in Acute Respiratory Tract Infection, Flu, Human and COVID-19, sponsored by CEN Biotech. Completed at 1 site in France. Open to participants aged 18 Years to 84 Years. Per ClinicalTrials.gov, last updated 2025-08-07.
Sponsored by CEN Biotech · Not applicable, Interventional, and Treatment
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.
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.
2,356 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.
This study's enrollment of 76 is below the median of 227 across 1,957 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →CEN Biotech is the lead sponsor of 18 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Analgesics and antipyretics are authorized. Any nasal spray, nasal cleansing (saline, water or other), and inhalation are prohibited
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.
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).
Time frame: 84 hours
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: day 8
Patient opinion of nasal spray
Patients treated with the nasal spray complete a satisfaction questionnaire designed for the study, and their responses are assessed using Likert scales.
Time frame: day 8
Nasal spray safety
Frequency and description of device deficiencies or difficulties in using the nasal spray reported by patients treated with the nasal spray.
Time frame: Day 8
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2024 to primary completion in Apr 2025, 14 months.
Of 166 interventional studies with no phase under Influenza, Human, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 16. This study's 14 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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