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

NCT05290987 | Terminated

• 1 other identifier: 2021-A01861-40
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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 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.

Conditions

SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Advanced Water S-100 ionized nasal spray

EXPERIMENTAL

2 sprays in each nostril, 6 times a day during 8 days

Device: nasal spray

Nasal spray with purified water

PLACEBO COMPARATOR

2 sprays in each nostril, 6 times a day during 8 days

Device: nasal spray

Interventions

nasal spray DEVICE

2 sprays in each nostril, 6 times a day

Advanced Water S-100 ionized nasal spray; Nasal spray with purified water

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• P & B Group: lead
• MediAxe CRO: collaborator

Study Sites (1)

Dr Bouvier's Office

Aix-en-Provence, 13100, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Christophe Bouvier, Dr

  independent oto rhino laryngologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, parallel-group study.

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 22, 2022
• Study Start: January 14, 2022
• Primary Completion: November 8, 2022
• Study Completion: November 8, 2022
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)