1.
ClinicalTrials.gov; 19/02/2024; TrialID: NCT06278324
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06278324
RESUMO
Condition:
Acute Respiratory Tract Infection;Flu, Human;COVID-19;Common ColdIntervention:
Device: Nasal Spray HSV TreatmentPrimary outcome:
Performance of nasal spray in eliminating virusesCriteria:
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.