Efficacy of mouthwashes in reducing SARS-CoV-2 viral load

• Research type

  Research Study

• Full title

  Efficacy of three antimicrobial mouthwashes in reducing SARS-CoV-2 viral load in the saliva of patients diagnosed with COVID-19: A pilot study.

• IRAS ID

  289334

• Contact name

  Nikos Donos

• Contact email

  n.donos@qmul.ac.uk

• Sponsor organisation

  Queen Mary University London (QMUL)

• Eudract number

  2020-004097-22

• Clinicaltrials.gov Identifier

  NCT04723446

• Duration of Study in the UK

  0 years, 9 months, 30 days

• Research summary

  A convenient sample of 40 COVID-19 positive patients will be identified in the inpatient clinics at the Newham University Hospital and The Royal London Hospital, both Barts Health NHS Trust, UK. However, as we also recruit patients who are presenting with suspected COVID-19 clinical symptoms before or after being confirmed via a diagnostic test we may have to recruit more than 40 potentially eligible patients in order to confirm 40 COVID-19 positive patients.

  The aim of this clinical study is to evaluate and compare the ability of 3 different mouthwashes in reducing the viral load (amount of virus) in the COVID-19 positive patient saliva. We will also compare the ability of reducing the viral load between rinsing with any of this mouthwash mentioned above to not rinsing at all.

  This study will consist of one visit (about 4 hours).

  Patients will be randomly allocated to one of the four study groups (10 patients in each group):
  Group 1- 0.2 % Chlorhexidine digluconate (Corsodyl® Alcohol free)
  Group 2- 1.5% Hydrogen peroxide (Colgate Peroxyl®)
  Group 3- Cetylpyridinium chloride (Oral-B® Gum & Enamel Care)
  Group 4- No rinsing

  Throughout the single study visit, they will be asked to self collect their saliva samples which they will spit into a tube before and at 30 minutes, 1, 2 and 3 hours after mouth rinsing or no rinsing.

  In addition to those 40 COVID-19 positive patients up to 5 COVID-19 negative participants will be recruited as volunteers from Barts Heath NHS trust or Institute of Dentistry staff in order to set up the reference saliva samples ‘profile’ of COVID-19 negative volunteers.

  Viral load analysis of saliva samples in the different time-points will be then assessed by Reverse Transcription quantitative PCR (RT- qPCR) in the sponsor’s lead Institute laboratories at QMUL in the Blizard Institute.

• REC name

  West Midlands - Solihull Research Ethics Committee

• REC reference

  21/WM/0068

• Date of REC Opinion

  20 Apr 2021

• REC opinion

  Further Information Favourable Opinion