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

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.

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.

Study Overview

• Status: Terminated
• Conditions: SARS-CoV-2 Infection
• Intervention / Treatment: Device: nasal spray

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Aix-en-Provence, France, 13100
    • Dr Bouvier's Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Men and women ≥ 18 years old
2. Informed consent
3. Beneficiaries of a social security plan

4. 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
5. Positive nasopharyngeal RT-PCR test for selection with a Ct viral load ≤ 23
6. Have a phone and internet connection to access the entry application

Exclusion Criteria:

1. The participant is related to any member of the study staff or has a close relationship or conflict of interest with the sponsor.
2. Known hypersensitivity or allergy to any component of the test product.
3. Contraindication to nasal spray

4. 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.
5. Any condition, including COVID, that is likely to result in hospitalization during study participation.
6. Conditions that may result in hospitalization during study participation.
7. Known pregnancy or positive urine pregnancy test at D0 by the nurse, or current breastfeeding
8. Participation in an antiviral clinical trial or other trial using a medical device for disease prevention COVID 19

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: P & B Group
• Collaborators: MediAxe CRO
• Investigators: Principal Investigator: Christophe Bouvier, Dr, independent oto rhino laryngologist

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2022
• Primary Completion (Actual): November 8, 2022
• Study Completion (Actual): November 8, 2022

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (Actual): March 22, 2022

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2021-A01861-40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Trial prematurely stopped as recruitment interrupted with less than 10% participants included

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No