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Trial - NCT04820803


Column Value
Trial registration number NCT04820803
Full text link
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

First author
Last imported at : July 8, 2021, 4 a.m.
Source : ClinicalTrials.gov

ROSA TARRAGÓ GIL

Contact
Last imported at : July 8, 2021, 4 a.m.
Source : ClinicalTrials.gov

rmtarrago@salud.aragon.es

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

2021-03-29

Recruitment status
Last imported at : July 8, 2021, 4 a.m.
Source : ClinicalTrials.gov

Completed

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

RCT

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

Randomized

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

Parallel

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

Treatment

Inclusion criteria
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - outpatients older than 18 years and younger than 80 years. - patients with a medical indication for a diagnostic test for active infection to sars-cov-2 - patients who present mild symptoms typical of covid-19 and who have less than three days of evolution - patients who have cognitive and motor skills to perform mouthwash correctly. - patients who understand and speak spanish - patients who freely give their consent to participate in the study, after a correct understanding of its objectives and procedures.

Exclusion criteria
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- patients with hospitalization criteria (moderate or severe symptoms) - vulnerable populations such as pregnant, lactating, - patients with recent medical diagnosis (≤ 1 month) of pneumonia - patients with hyposialia - patients with consumption of oral antiseptics (in the form of mouthwash containing cpc, povidone iodine rinses, alcohol mouthwash and essential oils) and toothpastes with cpc during the last month. - patients with cognitive impairment

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

2

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

Rosa Tarrago

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

18

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

80

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

Spain

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

Mild disease at enrollment

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

1: Mild disease at enrollment

Total sample size
Last imported at : March 31, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

80

primary outcome
Last imported at : July 8, 2021, 4 a.m.
Source : ClinicalTrials.gov

SARS-CoV-2 Nucleocapsid protein in saliva by ELISA;Threshold cycle value of SARS-CoV-2 by Polymerase Chain Reaction (PCR) in saliva samples

Notes
Last imported at : March 31, 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 : March 31, 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"}]