| Trial registration number
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ISRCTN25647404 |
Full text link
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)
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https://www.isrctn.com/ISRCTN25647404
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First author
Last imported at : Nov. 12, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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David Thomas
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Contact
Last imported at : Nov. 12, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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thomasdw2@cardiff.ac.uk
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Registration date
Last imported at : Nov. 12, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2020-11-09
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Recruitment status
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : Nov. 12, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Nov. 12, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Nov. 12, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Nov. 12, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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Center
Last imported at : Nov. 12, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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multi-center
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Study aim
Last imported at : Nov. 12, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Treatment
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Inclusion criteria
Last imported at : Nov. 12, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Eligible patients will be approached and recruited from COVID in-patient wards within Cardiff and Vale University Health Board, Betsi Cadwaladr University Health Board, University Hospitals Bristol NHS Foundation Trust and Cwm Taf Morganwg University Health Board. Only patients who are deemed well enough and able to provide informed consent by their local clinical teams will be approached to take part in the study. Specific inclusion criteria are: 1. Adults aged =18 years 2. With positive SARS-CoV-2 carriage by RT-PCR within 14 days 3. Capable of using the mouthwash required by the trial 4. Capacity and capability to give informed consent to take part in the trial
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Exclusion criteria
Last imported at : Nov. 12, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. Known or suspected intolerance or hypersensitivity to povidone-iodine or other study materials (or closely related compounds) or any of their stated ingredients 2. Known pregnancy, currently breastfeeding or women of childbearing age without effective contraception 3. Current requirement for invasive or non-invasive ventilation, or planned within next 6 hours 4. Known dermatitis herpetiformis (Duhring's disease) 5. Inability to communicate in English or read English
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Number of arms
Last imported at : Nov. 12, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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4
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Funding
Last imported at : Nov. 12, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Cardiff University
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Inclusion age min
Last imported at : Nov. 12, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : Nov. 12, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : Nov. 12, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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United Kingdom
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Type of patients
Last imported at : Nov. 12, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Mild/moderate disease at enrollment
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Severity scale
Last imported at : Nov. 12, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2: Mild/moderate disease at enrollment
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Total sample size
Last imported at : Nov. 12, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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104
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primary outcome
Last imported at : Nov. 12, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Viral load of SARS CoV-2 measured by in vitro culture and confirmed by RT-qPCR at 30 minutes
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Notes
Last imported at : Nov. 12, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : Nov. 12, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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Arms
Last imported at : Nov. 12, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "0.05%", "treatment_id": 268, "treatment_name": "Cetylpyridinium chloride", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "0.1%", "treatment_id": 268, "treatment_name": "Cetylpyridinium chloride", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1015, "treatment_name": "Povidone-iodine", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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