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Trial - NCT04757818


Column Value
Trial registration number NCT04757818
Full text link
Last imported at : Feb. 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04757818

First author
Last imported at : July 20, 2021, 4 p.m.
Source : ClinicalTrials.gov

Oriol Mitjà Villar, PhD, MD

Contact
Last imported at : July 20, 2021, 4 p.m.
Source : ClinicalTrials.gov

omitja@flsida.org

Registration date
Last imported at : Feb. 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-02-17

Recruitment status
Last imported at : July 20, 2021, 4 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Feb. 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Feb. 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Feb. 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Feb. 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Feb. 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: age equal to or greater than 18 years 2. confirmation of sars-cov-2 infection, determined by pcr or validated rapid antigen test1 from a nasopharyngeal smear performed in ≤3 days. without symptoms of covid-19 or with symptoms with ≤3 days of evolution cognitive and motor ability to perform mouthwashes and gargles willingness to comply with the requirements of the protocol understanding of the information provided in relation to the objectives and procedures provide your consent freely to participate in the study.

Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

use of mouthwashes, in the last 24 hours use of vitis pastes and / or perio aid gel, in the last 24 hours four or more days of symptoms compatible with covid-19. recent medical diagnosis (≤ 1 month) of pneumonia cognitive impairment or other reason that, in the investigator's discretion, contraindicates participation in the study hyposialia

Number of arms
Last imported at : Feb. 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Feb. 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Dentaid SL

Inclusion age min
Last imported at : Feb. 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Feb. 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Feb. 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Spain

Type of patients
Last imported at : Feb. 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : Feb. 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

1: Mild disease at enrollment

Total sample size
Last imported at : July 20, 2021, 4 p.m.
Source : ClinicalTrials.gov

118

primary outcome
Last imported at : July 20, 2021, 4 p.m.
Source : ClinicalTrials.gov

Nucleocapsid protein levels in saliva samples measured by ELISA;SARS-CoV-2 viral load in saliva samples measured by RT-qPCR

Notes
Last imported at : Feb. 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : Feb. 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 268, "treatment_name": "Cetylpyridinium chloride", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]