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Trial - ISRCTN16269648


Column Value
Trial registration number ISRCTN16269648
Full text link
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

https://www.isrctn.com/ISRCTN16269648

First author
Last imported at : July 2, 2021, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Mia Porteous

Contact
Last imported at : July 2, 2021, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

mia.porteous@york.nhs.uk

Registration date
Last imported at : July 2, 2021, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2021-06-24

Recruitment status
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not recruiting

Study design
Last imported at : July 2, 2021, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : July 2, 2021, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : July 2, 2021, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : July 2, 2021, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not reported

Center
Last imported at : July 2, 2021, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

single-center

Study aim
Last imported at : July 2, 2021, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Treatment

Inclusion criteria
Last imported at : July 2, 2021, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1. Participants aged over 16 years with a positive COVID-19 swab test in the last 72 hours 2. Participants will only be recruited if they are well enough, i.e. only showing mild to moderate symptoms/signs of COVID-19 infection

Exclusion criteria
Last imported at : July 2, 2021, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1. Refusal of consent 2. Participants known to be pregnant 3. Participants who have allergies to any of the mouthwashes used in the trial

Number of arms
Last imported at : July 2, 2021, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

4

Funding
Last imported at : July 2, 2021, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

York Teaching Hospital NHS Foundation Trust

Inclusion age min
Last imported at : July 2, 2021, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

16

Inclusion age max
Last imported at : July 2, 2021, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

100

Countries
Last imported at : July 2, 2021, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

United Kingdom

Type of patients
Last imported at : July 2, 2021, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Mild/moderate disease at enrollment

Severity scale
Last imported at : July 2, 2021, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : July 2, 2021, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

92

primary outcome
Last imported at : July 2, 2021, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Levels of SARS-CoV-2 in saliva samples measured quantitatively by determining the 50% tissue culture infectious dose (TCID50) and the infectious virus titre in TCID50/ml; at baseline (pre-mouth washing) and 1; 10; 30 and 60 minutes after mouth washing

Notes
Last imported at : July 2, 2021, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

| Declared number of arm (4.0) differs from found arms (5.0)

Phase
Last imported at : July 2, 2021, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not reported

Arms
Last imported at : July 2, 2021, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "", "treatment_id": 614, "treatment_name": "Hypochlorous acid", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "Listerine Total Care (eucalyptol, thymol, menthol, sodium fluoride, zinc chloride)", "treatment_id": 736, "treatment_name": "Listerine", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "Listerine Cool Mint (alcohol, eucalyptol, thymol, menthol)", "treatment_id": 736, "treatment_name": "Listerine", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]