Efficacy of ADW S-100 Ionized Water Nasal Spray in Decreasing SARS-Cov-2 Viral Load.

Study Overview
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Brief Summary
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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 prevention of the seizure of the SARS-COV-2 to the epithelial cells of the nasal cavity In fact, a nasal spray based on Advanced Water S-100 ionized water would modify the electrostatic environment of all interactions ensuring this seizure. The negative ions (OH-) contained in Advanced Water S-100 compete with the negative ions of the heparan sulfate, which will destabilize this essential bond for the virus to enter the host cell. In addition, positively charged basic amino acids, in the presence of the basic pH of ADW S-100, will be neutralized by OH- ions which will prevent the formation of salt and hydrogen bridges mediating the formation of the protein S/ACE2 complex. The destabilization of all bonds governing the protein S/ACE2 association process will prevent the virus from entering cells and replicating. The aim of this study is to evaluate whether the use of ADW S-100 ionized water nasal spray reduces the salivary and nasopharyngeal viral load during an 8-day follow-up of persons recently infected with SARS-Cov-2, and thus potentially decreases the risk of contamination of the entourage.

Official Title
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Efficacy of ADW S-100 Ionized Water Nasal Spray in Decreasing SARS-Cov-2 Viral Load in Adults With High Viral Excretion by Nasopharyngeal Swabbing. Randomized, Double-blind, Placebo-controlled, Parallel Group Study.

Conditions
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SARS-CoV-2 Infection

Intervention / Treatment
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* Device: nasal spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double-blind, placebo-controlled, parallel-group study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Advanced Water S-100 ionized nasal spray<br>2 sprays in each nostril, 6 times a day during 8 days | Device: nasal spray<br>* 2 sprays in each nostril, 6 times a day<br>|
| Placebo Comparator: Nasal spray with purified water<br>2 sprays in each nostril, 6 times a day during 8 days | Device: nasal spray<br>* 2 sprays in each nostril, 6 times a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether, compared to placebo, ADW S-100 ionized water administered as a nasal spray more rapidly negatively affects the viral load of individuals infected with SARS-CoV-2 | % of participants negative at D4 (Ct≥35) | 8 days |