MOMA_V1.0 [COVID-19]
Research type
Research Study
Full title
Measurement of mouthwash anti-viral activity against COVID-19
IRAS ID
285247
Contact name
D. W. Thomas
Contact email
Sponsor organisation
Cardiff University
ISRCTN Number
ISRCTN25647404
Duration of Study in the UK
0 years, 5 months, 0 days
Research summary
The mouthwashes tested here are all licensed for use, therefore, choosing from the literature which key components to test was discussed in detail. A recently published literature review conducted by members of this study (10.1093/function/zqaa002) highlighted the two key components to study for maximum chance of efficacy in human trials.
Furthermore, the decision to take the trial as a multi-centre approach raises issues of COVID-19 HTA sample transfer between sites. Management issues have been carefully planned for safe transfer of samples to Cardiff University virology lab. The reason this was opted for is two-fold, to make sure we get enough patients (104) to obtain significance, if present (as estimated by Professor Adrian Mander). Secondly, the dental profession is currently in crisis as routine dental care has been running on limited capacity for over 3 months. This leaves millions of lost appointments and results in a negative impact on oral health. If the results here are positive it could help resume dental care by lowering the COVID-19 viral load in the oral cavity, reducing the exposure to the dental care professionals, therefore, to accelerate the study 4 hospitals have been included.
The purpose of this study is to lower the COVID-19 viral load exposure to health care professionals working in the oral cavity. Moreover, with the knowledge of “super-spreaders”, these are at risk of entering the dental surgery once routine practice resumes, and lead to catastrophic consequences following an aerosol generating procedure. The existing literature demonstrated the efficacy of CPC and iodine in disrupting the viral envelope in laboratory-based studies and in viruses similar to COVID-19. The team has involved dentists, (including those running clinical trials units), microbiologists, virologists, medics (ENT surgeon, consultant physician specialising in acute medicine and infectious diseases) and statisticians. External scientific critique was then obtained from Cardiff Dental school peer review process.
Inclusion and exclusion criteria were written to make sure only those with capacity to consent and ‘well’ enough to participate were included. Also, it was very important to limit the research clinician’s time on the wards to reduce risk of exposure, as exhalations as well as saliva represent a health risk.. As the study has no direct benefit to the treatment of the patient, there are no ‘unfair’ exclusions; their disease will not improve following the single application of mouthwash treatment.
To reduce contact time with COVID-19 positive patients, the PIS form, consent and sample collection will be done in one visit. The research clinicians will make sure that the patients do not therefore feel under pressure to participate and will be allowed as much time as they wish to decide or discuss the study at length. We are using these agents as mouthwashes and specifically not “gargled” as these disinfectants should not be swallowed
There is no disadvantage to the patient of being allocated into the control group, as these mouthwashes will not treat the disease. This will simply give us a baseline of change in viral load without any active component present.
The consent form will contain NHS number, patients initials and signature. The consent will be linked with a study ID to the samples, making them link-anonymised. The results will contain no identifiable information to the patient. The samples will be destroyed following being analysed for the viral load content of COVID-19 .
The study is funded by Venture (who make Dentyl), they had no contribution to the design or delivery of the study.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
20/SC/0275
Date of REC Opinion
30 Jul 2020
REC opinion
Further Information Favourable Opinion