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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Aix-en-Provence、フランス、13100
- Dr Bouvier's Office
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Advanced Water S-100 ionized nasal spray
2 sprays in each nostril, 6 times a day during 8 days
|
2 sprays in each nostril, 6 times a day
|
|
プラセボコンパレーター：Nasal spray with purified water
2 sprays in each nostril, 6 times a day during 8 days
|
2 sprays in each nostril, 6 times a day
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：8 days
|
% of participants negative at D4 (Ct≥35)
|
8 days
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Christophe Bouvier, Dr、independent oto rhino laryngologist
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2021-A01861-40
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
SARS-CoV-2 感染症の臨床試験
-
AIM Vaccine Co., Ltd.Zhejiang Provincial Center for Disease Control and Preventionまだ募集していません
-
AIM Vaccine Co., Ltd.First Affiliated Hospital Bengbu Medical College; Ningbo Rongan Biological Pharmaceutical Co...まだ募集していません
-
AIM Vaccine Co., Ltd.First Affiliated Hospital Bengbu Medical College積極的、募集していない
-
AIM Vaccine Co., Ltd.Hunan Provincial Center for Disease Control and Prevention完了
-
Peking UniversityCenters for Disease Control and Prevention, China; Beijing Pinggu District Hospital; Peking University...完了
-
University Hospital, Montpelliersociete SkillCell - 97198 Jarry; CNRS Alcediag UMR9005 - societe Sys2Diag - 34184 Montpellier完了
nasal sprayの臨床試験
-
Fisher and Paykel Healthcare積極的、募集していない
-
University of WashingtonNational Heart, Lung, and Blood Institute (NHLBI)完了
-
University Hospital, Antwerp募集
-
Chulalongkorn University完了
-
University of Applied Sciences and Arts Northwestern...完了
-
El Instituto Nacional de Neurologia y Neurocirugia...Howard University完了