SARS-CoV-2 InfectionNCT05290987
Efficacy of ADW S-100 Ionized Water Nasal Spray in Decreasing SARS-Cov-2 Viral Load.
A study testing nasal spray in people with SARS-CoV-2 Infection, run by P & B Group at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- nasal spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2022to 8 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- nasal spray
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal sprayDevice
2 sprays in each nostril, 6 times a day
| Study group | Role | What they receive |
|---|---|---|
| Advanced Water S-100 ionized nasal spray | Experimental | 2 sprays in each nostril, 6 times a day during 8 days Receives: Device: nasal spray |
| Nasal spray with purified water | Placebo comparator | 2 sprays in each nostril, 6 times a day during 8 days Receives: Device: nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start14 Jan 2022
- Primary completion8 Nov 2022
- Study completion8 Nov 2022
Why it stopped: Number of participants needed not reached (13/80)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, parallel-group study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- P & B Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MediAxe CRO
- Responsible party
- Sponsor
- Investigators
- Christophe Bouvier, Dr, Principal investigator, independent oto rhino laryngologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290987
- Sponsor's protocol ID
- 2021-A01861-40
- Status last verified
- Nov 2022
- First submitted
- 14 Mar 2022
- Last updated
- 17 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Trial prematurely stopped as recruitment interrupted with less than 10% participants included
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05290987
- Acronym / sponsor ID
- 2021-A01861-40
- Conditions
- SARS-CoV-2 Infection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Number of participants needed not reached (13/80)
- Enrolment
- 13 participants (actual)
- Lead sponsor
- P & B GroupIndustry (pharma, biotech, devices)
- Collaborators
- MediAxe CRO
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 8 Nov 2022 (actual)
- Study completion
- 8 Nov 2022 (actual)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, parallel-group study.
| Arm | Type | Receives |
|---|---|---|
| Advanced Water S-100 ionized nasal spray | Experimental | Device: nasal spray2 sprays in each nostril, 6 times a day during 8 days |
| Nasal spray with purified water | Placebo comparator | Device: nasal spray2 sprays in each nostril, 6 times a day during 8 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women ≥ 18 years old
- Informed consent
- Beneficiaries of a social security plan
- Vaccinated or unvaccinated against SARS-COV-2:
- Positive nasopharyngeal RT-PCR test for selection with a Ct viral load ≤ 23
Key exclusion criteria (10 listed)
- 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
- Any condition, including COVID, that is likely to result in hospitalization during study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nasal spray2 sprays in each nostril, 6 times a day | Device | Advanced Water S-100 ionized nasal spray, Nasal spray with purified water |
Primary outcome
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
Time frame: 8 days
% of participants negative at D4 (Ct≥35)
Results and safety
The study was stopped early (reason given: Number of participants needed not reached (13/80)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Individual participant dataSharing planned: No. Trial prematurely stopped as recruitment interrupted with less than 10% participants included
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Bouvier, Dr principal investigator
independent oto rhino laryngologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasal spray in people with SARS-CoV-2 Infection, run by P & B Group at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Number of participants needed not reached (13/80)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.