Status:
TERMINATED
Efficacy of ADW S-100 Ionized Water Nasal Spray in Decreasing SARS-Cov-2 Viral Load.
Lead Sponsor:
P & B Group
Collaborating Sponsors:
MediAxe CRO
Conditions:
SARS-CoV-2 Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A nasal spray based on Advanced Water S-100 ionized water would clean the nasal cavity, reduce the viscosity of the mucus and facilitate its elimination and the decongestion of the nose and the preven...
Eligibility Criteria
Inclusion
- Men and women ≥ 18 years old
- Informed consent
- Beneficiaries of a social security plan
- Vaccinated or unvaccinated against SARS-COV-2:
- Vaccinated individuals have had a 3rd dose for at least one month, or have been infected with SARS-Cov-2 and have had 2 doses of vaccine for at least one month
- Unvaccinated persons are naïve to previous SARS Cov 2 infection
- Positive nasopharyngeal RT-PCR test for selection with a Ct viral load ≤ 23
- Have a phone and internet connection to access the entry application
Exclusion
- The participant is related to any member of the study staff or has a close relationship or conflict of interest with the sponsor.
- Known hypersensitivity or allergy to any component of the test product.
- Contraindication to nasal spray
- Insufficient vaccination: any incomplete vaccination schedule
- either a 3rd dose within the last month
- or SARS-Cov-2 infection with less than 2 vaccine doses or with 2 vaccine doses less than 1 month old.
- Any condition, including COVID, that is likely to result in hospitalization during study participation.
- Conditions that may result in hospitalization during study participation.
- Known pregnancy or positive urine pregnancy test at D0 by the nurse, or current breastfeeding
- Participation in an antiviral clinical trial or other trial using a medical device for disease prevention COVID 19
Key Trial Info
Start Date :
January 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT05290987
Start Date
January 14 2022
End Date
November 8 2022
Last Update
November 17 2022
Active Locations (1)
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1
Dr Bouvier's Office
Aix-en-Provence, France, 13100