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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT05290987 |
|
Full text link
Last imported at : March 23, 2022, 10 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : March 23, 2022, 10 a.m. Source : ClinicalTrials.gov |
2022-03-22 |
|
Recruitment status
Last imported at : Nov. 18, 2022, 4 a.m. Source : ClinicalTrials.gov |
Terminated |
|
Study design
Last imported at : March 23, 2022, 10 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : March 23, 2022, 10 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : March 23, 2022, 10 a.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : March 23, 2022, 10 a.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : March 23, 2022, 10 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : March 23, 2022, 10 a.m. Source : ClinicalTrials.gov |
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
Last imported at : March 23, 2022, 10 a.m. Source : ClinicalTrials.gov |
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 |
|
Number of arms
Last imported at : March 23, 2022, 10 a.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : March 23, 2022, 10 a.m. Source : ClinicalTrials.gov |
P & B Group |
|
Inclusion age min
Last imported at : March 23, 2022, 10 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : March 23, 2022, 10 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : March 23, 2022, 10 a.m. Source : ClinicalTrials.gov |
France |
|
Type of patients
Last imported at : March 23, 2022, 10 a.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
|
Severity scale
Last imported at : March 23, 2022, 10 a.m. Source : ClinicalTrials.gov |
1: Mild disease at enrollment |
|
Total sample size
Last imported at : Nov. 18, 2022, 4 a.m. Source : ClinicalTrials.gov |
13 |
|
primary outcome
Last imported at : March 23, 2022, 10 a.m. Source : ClinicalTrials.gov |
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 |
|
Notes
Last imported at : March 23, 2022, 10 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : March 23, 2022, 10 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Arms
Last imported at : March 23, 2022, 10 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 2406, "treatment_name": "Water s-100 ionized nasal spray", "treatment_type": "Nasal spray", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |