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

SARS-CoV-2 Infection Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05290987
• Other study ID #: 2021-A01861-40
• Status: Terminated
• Phase: N/A
• Start date: January 14, 2022
• Est. completion date: November 8, 2022

Study information

• Verified date: November 2022
• Source: P & B Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: November 8, 2022
• Est. primary completion date: November 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Intervention

Device:
• nasal spray
2 sprays in each nostril, 6 times a day

Locations

Country	Name	City	State
France	Dr Bouvier's Office	Aix-en-Provence

Sponsors (2)

Lead Sponsor	Collaborator
P & B Group	MediAxe CRO

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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