Celebrating 25 years of advancing clinical research: ISRCTN's milestone study registrations

For 25 years, ISRCTN has promoted transparency and accountability in clinical research, ensuring vital information is accessible to researchers, healthcare professionals, and the public. We mark our 25th anniversary by sharing a Q&A with David Thomas about the MOMA study, our 20,000th registration.
Celebrating 25 years of advancing clinical research: ISRCTN's milestone study registrations
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David Thomas is a Professor/Consultant in the Department of Oral and Maxillofacial Surgery. He is Innovation Lead at the Systems Immunity University Research Institute, Cardiff University, and runs the Advanced Therapies Group, undertaking research into the development of novel small molecule and polymer therapeutics, in the treatment of chronic infective and inflammatory diseases and translating their research to the clinic. 

Join us as we reflect on our journey by hearing about the MOMA study registered in November 2020.


What was your involvement in the MOMA study when it started? 

As the pandemic emerged, we had been working in a group led by Prof Val O’Donnell at Cardiff University and were interested in the viral lipid envelope as a target for therapeutics against SARS-CoV-2. My colleagues had demonstrated the effectiveness of this concept in vitro, thus, we designed and led the MOMA clinical study to test whether this was the case in vivo. If successful, we believed it could offer support in reducing viral load and reducing transmission. 

Man pouring mouthwash in to cap

Can you describe the study? 

The primary objective of the study, on hospitalised coronavirus (COVID-19) patients, was to determine if a mouthwash can reduce the amount of live virus within saliva? and, determine how long any effects persisted? 

How did the study aim to address key issues in clinical research?

We undertook a four-arm, randomised controlled trial comparing the effectiveness of anti-microbial mouthwashes to reduce salivary viral load in patients with COVID-19, and tested the substantivity of the effects. This study was performed on hospitalised COVID patients across Wales during the pandemic. Following a simple, 30-second oral rinse with 1 of 4 mouthwashes, saliva samples were collected for up to 1 hour and live viral titres quantified. In the study, we demonstrated the ability of a simple over-the-counter cetylpyridinium chloride mouthwash to effectively eliminate live virus in the oral cavity of patients with coronavirus disease 19 for at least 1 hour.  

Why was this study considered significant in the field of biomedical research? 

This was outlined by Prof Garret A. FitzGerald in his commentary ‘COVID-19: lipid disruption is pushing the envelope’ on our published article; The SARS-CoV2 envelope differs from host cells, exposes procoagulant lipids, and is disrupted in vivo by oral rinses; ‘Saud et al. presented a therapeutic opportunity that involves neither vaccines nor drugs. It may translate into a cheap and effective approach of relevance, not just to COVID-19, but generally to viral pandemics of the future; swilling and gargling mouthwash to disrupt the integrity of the lipid envelope that facilitates viral infection and proliferation.’.

Since you initially registered the study, how has the field progressed, and what was the significance of the results? 

Advances in clinical research have been made in understanding the importance of lipid dysregulation within the viral envelope and the host. Within the host, this is both in response to infection and directly mediating the pathological features of the disease. 

How did the results of your study contribute to these advancements?  

This study was the first to demonstrate the effectiveness of a mouthwash in reducing titres of live virus in COVID-19 patients. 

Can you highlight any notable impacts or changes in clinical practices resulting from your study? 

In future pandemics, we hope that such a simple approach may be used to safely treat patients in dental practice without the closure of dental services that occurred in the UK. 

A dentist wearing a face mask treating a patient in a dental surgery

Why was registration important to you?  

The benefits of the registration were “visibility” to the clinical, academic and patient communities participating in or interested in this research. It is also very useful in external review and monitoring of reported activity/clinical translation. 


You can continue celebrating our successes in forthcoming posts and following studies being registered at ISRCTN. We look forward to continuing our mission of supporting high-quality clinical research for the benefit of all. 

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Clinical Research
Life Sciences > Health Sciences > Biomedical Research > Clinical Research
Randomized Controlled Clinical Trials
Life Sciences > Health Sciences > Biomedical Research > Clinical Research > Clinical Trials > Clinical Trial Design > Randomized Controlled Clinical Trials
Infectious Diseases
Life Sciences > Health Sciences > Clinical Medicine > Diseases > Infectious Diseases
COVID19
Life Sciences > Health Sciences > Clinical Medicine > Diseases > Infectious Diseases > COVID19
Membrane Lipids
Life Sciences > Biological Sciences > Chemical Biology > Lipidology > Lipids > Membrane Lipids
  • ISRCTN registry ISRCTN registry

    A primary clinical trial registry recognised by WHO and ICMJE that accepts studies involving human subjects or populations with outcome measures assessing effects on human health and well-being, including studies in healthcare, social care, education, workplace safety and economic development.