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Trial - NCT04723446


Column Value
Trial registration number NCT04723446
Full text link
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04723446

First author
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

Prof Nikos Donos, PhD

Contact
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

Rinat Ezra, BHNT.Clinicaloralresearchcentre@nhs.net (PI email not reported)

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

2021-01-25

Recruitment status
Last imported at : Nov. 17, 2021, 7 p.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 : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

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

Treatment

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

all of the following criteria must be fulfilled for inclusion: - patients must have willingness to read and sign a copy of informed consent form. - males and females, ≥ 18 years old. - covid-19 positive patients confirmed via any diagnostic test and/or presented with covid-19 clinical symptoms at point of consent. exclusion criteria for patients patients presenting with any of the following will not be included in the trial: - known pre-existing chronic mucosal lesions e.g. lichen planus or other oropharyngeal lesions, reported by patient or recorded in the existing patient' medical notes; - patients currently intubated or not capable of mouth rinse or spit; - history of head and neck radiotherapy or chemotherapy; - self-reported xerostomia; - known allergy or hypersensitivity to chlorhexidine digluconate or one of the mouthwashes constituents; - other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial; - inability to comply with study protocol.

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

None

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

4

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

Queen Mary University of London

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 : April 25, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

United Kingdom

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

No restriction on type of patients

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

0: No restriction on type of patients

Total sample size
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

54

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

Viral load changes in the saliva within groups

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

[{"arm_notes": "", "treatment_id": 274, "treatment_name": "Chlorhexidine", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 606, "treatment_name": "Hydrogen peroxide", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 268, "treatment_name": "Cetylpyridinium chloride", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]