Back to resultsEfficacy of ADW S-100 Ionized Water Nasal Spray in Decreasing SARS-Cov-2 Viral Load.
Primary Purpose
SARS-CoV-2 Infection
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
nasal spray
Sponsored by
About this trial
This is an interventional prevention trial for SARS-CoV-2 Infection
Eligibility Criteria
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
Sites / Locations
- Dr Bouvier's Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Advanced Water S-100 ionized nasal spray
Nasal spray with purified water
Arm Description
2 sprays in each nostril, 6 times a day during 8 days
2 sprays in each nostril, 6 times a day during 8 days
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT05290987
First Posted
March 14, 2022
Last Updated
November 14, 2022
Sponsor
P & B Group
Collaborators
MediAxe CRO
1. Study Identification
Unique Protocol Identification Number
NCT05290987
Brief Title
Efficacy of ADW S-100 Ionized Water Nasal Spray in Decreasing SARS-Cov-2 Viral Load.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Number of participants needed not reached (13/80)
Study Start Date
January 14, 2022 (Actual)
Primary Completion Date
November 8, 2022 (Actual)
Study Completion Date
November 8, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
P & B Group
Collaborators
MediAxe CRO
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2 Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, placebo-controlled, parallel-group study.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Advanced Water S-100 ionized nasal spray
Arm Type
Experimental
Arm Description
2 sprays in each nostril, 6 times a day during 8 days
Arm Title
Nasal spray with purified water
Arm Type
Placebo Comparator
Arm Description
2 sprays in each nostril, 6 times a day during 8 days
Intervention Type
Device
Intervention Name(s)
nasal spray
Intervention Description
2 sprays in each nostril, 6 times a day
Primary Outcome Measure Information:
Title
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
Description
% of participants negative at D4 (Ct≥35)
Time Frame
8 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Bouvier, Dr
Organizational Affiliation
independent oto rhino laryngologist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Bouvier's Office
City
Aix-en-Provence
ZIP/Postal Code
13100
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Trial prematurely stopped as recruitment interrupted with less than 10% participants included
Learn more about this trial
Efficacy of ADW S-100 Ionized Water Nasal Spray in Decreasing SARS-Cov-2 Viral Load.
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