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Trial - NCT04721457


Column Value
Trial registration number NCT04721457
Full text link
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04721457

First author
Last imported at : Dec. 15, 2021, 1:30 a.m.
Source : ClinicalTrials.gov

MANAR M ALZAHRANI, MSD, FRCD(C)

Contact
Last imported at : Dec. 15, 2021, 1:30 a.m.
Source : ClinicalTrials.gov

mmalzhrani@kau.edu.sa

Registration date
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-01-22

Recruitment status
Last imported at : Dec. 15, 2021, 1:30 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Jan. 29, 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: adults age 18 years or older presented to tetamman clinics, jeddah, saudi arabia. covid-19 positive patients confirmed by rt-pcr and within two days of oral or nasopharyngeal swabs asymptomatic or within seven days of the onset of symptoms. has the ability to rinse and expectorate.

Exclusion criteria
Last imported at : July 23, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

participants who established antiviral, corticosteroid, antimicrobial, or immunosuppressive medications. known allergy to one of the constituents of the mouth rinse thyroid disease or on current radioactive iodine treatment pregnant or breastfeeding women lithium therapy history of radiotherapy or chemotherapy use of mouthwash before presented to tetamman clinics

Number of arms
Last imported at : July 23, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

6

Funding
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

King Abdulaziz University

Inclusion age min
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Saudi Arabia

Type of patients
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Mild/moderate disease at enrollment

Severity scale
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : July 23, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

90

primary outcome
Last imported at : July 23, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Change in the salivary viral load within each mouth rinse groups and controls;Compare salivary viral load between mouth rinse groups and controls at 30 minutes post rinsing;Compare salivary viral load between mouth rinse groups and controls at 5 minutes post rinsing;Compare salivary viral load between mouth rinse groups and controls at 60 minutes post rinsing;Compare salivary viral load between mouth rinse groups and controls at baseline

Notes
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 4

Arms
Last imported at : July 23, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "nan", "treatment_id": 2570, "treatment_name": "Distilled water", "treatment_type": "Nutrition", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 1015, "treatment_name": "Povidone-iodine", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 606, "treatment_name": "Hydrogen peroxide", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 268, "treatment_name": "Cetylpyridinium chloride", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 1216, "treatment_name": "Sodium hypochlorite", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]