Covid19COVID-19NCT04723446

Efficacy of Mouthwashes in Reducing Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load in the Saliva

A study testing Corsodyl® Alcohol free -0.2 % Chlorhexidine digluconate, Colgate Peroxyl® -1.5% Hydrogen peroxide and Oral-B® Gum & Enamel Care -Cetylpyridinium chloride in people with Covid19 and Coronavirus, run by Queen Mary University of London at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a single-blind, parallel-group, randomized pilot study designed to evaluate and compare the efficacy of 3 different mouthwashes containing 0.2% Chlorhexidine digluconate, 1.5% Hydroxide peroxide or Cetylpyridinium chloride in reducing Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load in… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Covid19, Coronavirus
What is being tested?: Corsodyl® Alcohol free -0.2 % Chlorhexidine digluconate, Colgate Peroxyl® -1.5% Hydrogen peroxide and Oral-B® Gum & Enamel Care -Cetylpyridinium chloride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 2 sitesUnited Kingdom
Study dates: 19 May 2021to 25 Oct 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

Patients presenting with any of the following will not be included in the trial:
Known pre-existing chronic mucosal lesions e.g. lichen planus or other oropharyngeal lesions, reported by patient or recorded in the existing patient' medical notes;
Patients currently intubated or not capable of mouth rinse or spit;
History of head and neck radiotherapy or chemotherapy;
Self-reported xerostomia;
Known allergy or hypersensitivity to chlorhexidine digluconate or one of the mouthwashes constituents;
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial;
Inability to comply with study protocol.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

Newham Hospital
London
Royal London Hospital
London

Other trials in United Kingdom

About this study

Official 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

A convenient sample of up to 40 COVID-19 positive patients diagnosed via test and/or presenting COVID-19 clinical symptoms will be identified in the inpatients and/or outpatient clinics at the Newham University Hospital and at The Royal London Hospital, Barts Health National Health Service (NHS) Trust, United Kingdom (UK).

The study will consist of one visit. Unstimulated saliva samples will be collected from all COVID-19 positive patients before and at 30 minutes, 1, 2, and 3 hours after mouth rinsing (Group 1-3 ) or no rinsing (Group 4). Viral load analysis of saliva samples in the different time-points will be then assessed by Reverse Transcription quantitative PCR (RT- qPCR).

Conditions: Covid19, Coronavirus
Being tested: Corsodyl® Alcohol free -0.2 % Chlorhexidine digluconate, Colgate Peroxyl® -1.5% Hydrogen peroxide, Oral-B® Gum & Enamel Care -Cetylpyridinium chloride, No rinsing
Keywords: Mouthwash, Chlorhexidine digluconate, Hydroxide peroxide, Cetylpyridinium chloride, Viral load, SARS-CoV-2
Medical subject headings: COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Corsodyl® Alcohol free -0.2 % Chlorhexidine digluconateDrug
Corsodyl® Alcohol-free is a clear to slightly opalescent oromucosal solution with an odour of peppermint that contains 0.2% w/v chlorhexidine digluconate which is an antimicrobial preparation for external use. It is effective against a wide range of Gram negative and Gram positive vegetative bacteria, yeasts, dermatophyte fungi and lipophilic viruses. It is active against a wide range of important oral pathogens and is therefore effective in the treatment of many common oral conditions.
Colgate Peroxyl® -1.5% Hydrogen peroxideDrug
Peroxyl mouthwash is a clear aqua-blue liquid oromucosal solution which 100ml of solution contains 1.5g of Hydrogen peroxide (as 30% Hydrogen Peroxide solution). It is an oral antiseptic cleanser for external use. The principal action is brought about by contact of hydrogen peroxide with peroxidases and catalases present in tissues and saliva, which causes the rapid release of oxygen. This provides mechanical cleansing which flushes out mouth debris and helps in the treatment of oral irritations. This mouthwash is used as a cleanser in the symptomatic relief of minor mouth and gum irritations.
Oral-B® Gum & Enamel Care -Cetylpyridinium chlorideOther
Also called Cosmetic product
The Oral-B® Gum \& Enamel Care mouthwash is an oromucosal solution containing Cetylpyridinium chloride (CPC) and used as an adjunct to oral hygiene.
No rinsingOther
No rinsing

Study groups in NCT04723446
Study group	Role	What they receive
Group 1 (test group; n= up to 10 patients) - 0.2 % Chlorhexidine digluconate	Experimental	Participants will be instructed to rinse their mouth with 10 ml of Corsodyl® Alcohol free mouthwash for 1 minute. Receives: Drug: Corsodyl® Alcohol free -0.2 % Chlorhexidine digluconate
Group 2 (test group; n= up to 10 patients) - 1.5% Hydrogen peroxide	Experimental	Participants will be instructed to rinse their mouth with 10 ml of Colgate® Peroxyl mouthwash for 1 minute. Receives: Drug: Colgate Peroxyl® -1.5% Hydrogen peroxide
Group 3 (test group; n= up to 10 patients) - Cetylpyridinium chloride	Experimental	Participants will be instructed to rinse their mouth with 10 ml of Oral-B® Gum \& Enamel Care mouthwashes for 1 minute. Receives: Other: Oral-B® Gum & Enamel Care -Cetylpyridinium chloride
Group 4 (control group; n= up to 10 patients) - No rinsing	Experimental	Patients will be instructed to not rinse their mouth with any solution, not even water. Receives: Other: No rinsing

What is being measured

The primary outcome is the main question the study is designed to answer.

Viral load changes in the saliva within groups
Viral load changes in the saliva of COVID-19 positive patients assessed by RT-qPCR assays at 30 minutes, 1, 2 and 3 hours after mouth rinsing with a mouthwash containing 0.2 % Chlorhexidine digluconate, 1.5% Hydroxide peroxide or Cetylpyridinium chloride compared to baseline.
Measured: 30 minutes, 1, 2 and 3 hours after mouth rinsing or no rinsing.

Secondary outcomes (1)

Difference in the viral load changes in the saliva between groups
Difference in the viral load changes in the saliva of COVID-19 positive patients assessed by RT-qPCR assays, at the different study time-points, between groups 0.2 % Chlorhexidine digluconate, 1.5% Hydroxide peroxide, Cetylpyridinium chloride mouthwash and no rinsing (control).
Measured: 30 minutes, 1, 2 and 3 hours after mouth rinsing or no rinsing.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 May 202125 Oct 2021

First posted25 Jan 2021
Study start19 May 2021
Primary completion25 Oct 2021
Study completion25 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (25)Papers the sponsor has linked to this study.
Other trials for Covid19Studies of the same condition, open and under way.
More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04723446
Sponsor's protocol ID: TBC
Acronym: COVID-19
Status last verified: Nov 2021
First submitted: 5 Jan 2021
Last updated: 14 Sep 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Aggregated/collective data regarding the efficacy of the different mouthwashes will be shared with the scientific community as a de-identified/coded information

Publications

Bernstein D, Schiff G, Echler G, Prince A, Feller M, Briner W. In vitro virucidal effectiveness of a 0.12%-chlorhexidine gluconate mouthrinse. J Dent Res. 1990 Mar;69(3):874-6. doi: 10.1177/00220345900690030901.
PubMed 2109001
Caruso AA, Del Prete A, Lazzarino AI, Capaldi R, Grumetto L. Might hydrogen peroxide reduce the hospitalization rate and complications of SARS-CoV-2 infection? Infect Control Hosp Epidemiol. 2020 Nov;41(11):1360-1361. doi: 10.1017/ice.2020.170. Epub 2020 Apr 22. No abstract available.
PubMed 32319881
Cheng VCC, Wong SC, Kwan GSW, Hui WT, Yuen KY. Disinfection of N95 respirators by ionized hydrogen peroxide during pandemic coronavirus disease 2019 (COVID-19) due to SARS-CoV-2. J Hosp Infect. 2020 Jun;105(2):358-359. doi: 10.1016/j.jhin.2020.04.003. Epub 2020 Apr 8. No abstract available.
PubMed 32277965
Corman VM, Landt O, Kaiser M, Molenkamp R, Meijer A, Chu DK, Bleicker T, Brunink S, Schneider J, Schmidt ML, Mulders DG, Haagmans BL, van der Veer B, van den Brink S, Wijsman L, Goderski G, Romette JL, Ellis J, Zambon M, Peiris M, Goossens H, Reusken C, Koopmans MP, Drosten C. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill. 2020 Jan;25(3):2000045. doi: 10.2807/1560-7917.ES.2020.25.3.2000045.
PubMed 31992387
Costa X, Laguna E, Herrera D, Serrano J, Alonso B, Sanz M. Efficacy of a new mouth rinse formulation based on 0.07% cetylpyridinium chloride in the control of plaque and gingivitis: a 6-month randomized clinical trial. J Clin Periodontol. 2013 Nov;40(11):1007-15. doi: 10.1111/jcpe.12158. Epub 2013 Sep 11.
PubMed 24024983
Eggers M, Eickmann M, Zorn J. Rapid and Effective Virucidal Activity of Povidone-Iodine Products Against Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and Modified Vaccinia Virus Ankara (MVA). Infect Dis Ther. 2015 Dec;4(4):491-501. doi: 10.1007/s40121-015-0091-9. Epub 2015 Sep 28.
PubMed 26416214
Gottsauner MJ, Michaelides I, Schmidt B, Scholz KJ, Buchalla W, Widbiller M, Hitzenbichler F, Ettl T, Reichert TE, Bohr C, Vielsmeier V, Cieplik F. A prospective clinical pilot study on the effects of a hydrogen peroxide mouthrinse on the intraoral viral load of SARS-CoV-2. Clin Oral Investig. 2020 Oct;24(10):3707-3713. doi: 10.1007/s00784-020-03549-1. Epub 2020 Sep 2.
PubMed 32876748
Gusberti FA, Sampathkumar P, Siegrist BE, Lang NP. Microbiological and clinical effects of chlorhexidine digluconate and hydrogen peroxide mouthrinses on developing plaque and gingivitis. J Clin Periodontol. 1988 Jan;15(1):60-7. doi: 10.1111/j.1600-051x.1988.tb01556.x.
PubMed 3422246
Hossainian N, Slot DE, Afennich F, Van der Weijden GA. The effects of hydrogen peroxide mouthwashes on the prevention of plaque and gingival inflammation: a systematic review. Int J Dent Hyg. 2011 Aug;9(3):171-81. doi: 10.1111/j.1601-5037.2010.00492.x. Epub 2011 Jan 31.
PubMed 21356027
Kampf G, Todt D, Pfaender S, Steinmann E. Persistence of coronaviruses on inanimate surfaces and their inactivation with biocidal agents. J Hosp Infect. 2020 Mar;104(3):246-251. doi: 10.1016/j.jhin.2020.01.022. Epub 2020 Feb 6.
PubMed 32035997
Kronbichler A, Kresse D, Yoon S, Lee KH, Effenberger M, Shin JI. Asymptomatic patients as a source of COVID-19 infections: A systematic review and meta-analysis. Int J Infect Dis. 2020 Sep;98:180-186. doi: 10.1016/j.ijid.2020.06.052. Epub 2020 Jun 17.
PubMed 32562846
Marui VC, Souto MLS, Rovai ES, Romito GA, Chambrone L, Pannuti CM. Efficacy of preprocedural mouthrinses in the reduction of microorganisms in aerosol: A systematic review. J Am Dent Assoc. 2019 Dec;150(12):1015-1026.e1. doi: 10.1016/j.adaj.2019.06.024.
PubMed 31761015
Naik S, Tredwin CJ, Scully C. Hydrogen peroxide tooth-whitening (bleaching): review of safety in relation to possible carcinogenesis. Oral Oncol. 2006 Aug;42(7):668-74. doi: 10.1016/j.oraloncology.2005.10.020. Epub 2006 Feb 20.
PubMed 16488181
Pan Y, Zhang D, Yang P, Poon LLM, Wang Q. Viral load of SARS-CoV-2 in clinical samples. Lancet Infect Dis. 2020 Apr;20(4):411-412. doi: 10.1016/S1473-3099(20)30113-4. Epub 2020 Feb 24. No abstract available.
PubMed 32105638
Pan Y, Liu H, Chu C, Li X, Liu S, Lu S. Transmission routes of SARS-CoV-2 and protective measures in dental clinics during the COVID-19 pandemic. Am J Dent. 2020 Jun;33(3):129-134.
PubMed 32470237

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT04723446
Acronym / sponsor ID: COVID-19 / TBC
Conditions: Covid19, Coronavirus
Keywords: Mouthwash, Chlorhexidine digluconate, Hydroxide peroxide, Cetylpyridinium chloride, Viral load, SARS-CoV-2
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Queen Mary University of LondonUniversity, hospital or other
Collaborators: GlaxoSmithKline
Study start: 19 May 2021 (actual)
Primary completion: 25 Oct 2021 (actual)
Study completion: 25 Oct 2021 (actual)
First posted: 25 Jan 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 4

Arm	Type	Receives
Group 1 (test group; n= up to 10 patients) - 0.2 % Chlorhexidine digluconate	Experimental	Drug: Corsodyl® Alcohol free -0.2 % Chlorhexidine digluconateParticipants will be instructed to rinse their mouth with 10 ml of Corsodyl® Alcohol free mouthwash for 1 minute.
Group 2 (test group; n= up to 10 patients) - 1.5% Hydrogen peroxide	Experimental	Drug: Colgate Peroxyl® -1.5% Hydrogen peroxideParticipants will be instructed to rinse their mouth with 10 ml of Colgate® Peroxyl mouthwash for 1 minute.
Group 3 (test group; n= up to 10 patients) - Cetylpyridinium chloride	Experimental	Other: Oral-B® Gum & Enamel Care -Cetylpyridinium chlorideParticipants will be instructed to rinse their mouth with 10 ml of Oral-B® Gum \& Enamel Care mouthwashes for 1 minute.
Group 4 (control group; n= up to 10 patients) - No rinsing	Experimental	Other: No rinsingPatients will be instructed to not rinse their mouth with any solution, not even water.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (8 listed)

Known pre-existing chronic mucosal lesions e.g. lichen planus or other oropharyngeal lesions, reported by patient or recorded in the existing patient' medical notes;
Patients currently intubated or not capable of mouth rinse or spit;
History of head and neck radiotherapy or chemotherapy;
Self-reported xerostomia;
Known allergy or hypersensitivity to chlorhexidine digluconate or one of the mouthwashes constituents;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Corsodyl® Alcohol free -0.2 % Chlorhexidine digluconateCorsodyl® Alcohol-free is a clear to slightly opalescent oromucosal solution with an odour of peppermint that contains 0.2% w/v chlorhexidine digluconate which is an antimicrobial preparation for external use. It is effective against a wide range of Gram negative and Gram positive vegetative bacteria, yeasts, dermatophyte fungi and lipophilic viruses. It is active against a wide range of important oral pathogens and is therefore effective in the treatment of many common oral conditions.	Drug	Group 1 (test group; n= up to 10 patients) - 0.2 % Chlorhexidine digluconate
Colgate Peroxyl® -1.5% Hydrogen peroxidePeroxyl mouthwash is a clear aqua-blue liquid oromucosal solution which 100ml of solution contains 1.5g of Hydrogen peroxide (as 30% Hydrogen Peroxide solution). It is an oral antiseptic cleanser for external use. The principal action is brought about by contact of hydrogen peroxide with peroxidases and catalases present in tissues and saliva, which causes the rapid release of oxygen. This provides mechanical cleansing which flushes out mouth debris and helps in the treatment of oral irritations. This mouthwash is used as a cleanser in the symptomatic relief of minor mouth and gum irritations.	Drug	Group 2 (test group; n= up to 10 patients) - 1.5% Hydrogen peroxide
Oral-B® Gum & Enamel Care -Cetylpyridinium chlorideAlso: Cosmetic productThe Oral-B® Gum \& Enamel Care mouthwash is an oromucosal solution containing Cetylpyridinium chloride (CPC) and used as an adjunct to oral hygiene.	Other	Group 3 (test group; n= up to 10 patients) - Cetylpyridinium chloride
No rinsingNo rinsing	Other	Group 4 (control group; n= up to 10 patients) - No rinsing

Primary outcome

Viral load changes in the saliva within groups
Time frame: 30 minutes, 1, 2 and 3 hours after mouth rinsing or no rinsing.
Viral load changes in the saliva of COVID-19 positive patients assessed by RT-qPCR assays at 30 minutes, 1, 2 and 3 hours after mouth rinsing with a mouthwash containing 0.2 % Chlorhexidine digluconate, 1.5% Hydroxide peroxide or Cetylpyridinium chloride compared to baseline.

1 secondary outcome

Difference in the viral load changes in the saliva between groups
Time frame: 30 minutes, 1, 2 and 3 hours after mouth rinsing or no rinsing.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
Background: PubMed 2109001Bernstein D, Schiff G, Echler G, Prince A, Feller M, Briner W. In vitro virucidal effectiveness of a 0.12%-chlorhexidine gluconate mouthrinse. J Dent Res. 1990 Mar;69(3):874-6. doi: 10.1177/00220345900690030901.
Background: PubMed 32319881Caruso AA, Del Prete A, Lazzarino AI, Capaldi R, Grumetto L. Might hydrogen peroxide reduce the hospitalization rate and complications of SARS-CoV-2 infection? Infect Control Hosp Epidemiol. 2020 Nov;41(11):1360-1361. doi: 10.1017/ice.2020.170. Epub 2020 Apr 22. No abstract available.
Background: PubMed 32277965Cheng VCC, Wong SC, Kwan GSW, Hui WT, Yuen KY. Disinfection of N95 respirators by ionized hydrogen peroxide during pandemic coronavirus disease 2019 (COVID-19) due to SARS-CoV-2. J Hosp Infect. 2020 Jun;105(2):358-359. doi: 10.1016/j.jhin.2020.04.003. Epub 2020 Apr 8. No abstract available.
Background: PubMed 31992387Corman VM, Landt O, Kaiser M, Molenkamp R, Meijer A, Chu DK, Bleicker T, Brunink S, Schneider J, Schmidt ML, Mulders DG, Haagmans BL, van der Veer B, van den Brink S, Wijsman L, Goderski G, Romette JL, Ellis J, Zambon M, Peiris M, Goossens H, Reusken C, Koopmans MP, Drosten C. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill. 2020 Jan;25(3):2000045. doi: 10.2807/1560-7917.ES.2020.25.3.2000045.
Background: PubMed 24024983Costa X, Laguna E, Herrera D, Serrano J, Alonso B, Sanz M. Efficacy of a new mouth rinse formulation based on 0.07% cetylpyridinium chloride in the control of plaque and gingivitis: a 6-month randomized clinical trial. J Clin Periodontol. 2013 Nov;40(11):1007-15. doi: 10.1111/jcpe.12158. Epub 2013 Sep 11.
Background: PubMed 26416214Eggers M, Eickmann M, Zorn J. Rapid and Effective Virucidal Activity of Povidone-Iodine Products Against Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and Modified Vaccinia Virus Ankara (MVA). Infect Dis Ther. 2015 Dec;4(4):491-501. doi: 10.1007/s40121-015-0091-9. Epub 2015 Sep 28.
Background: PubMed 32876748Gottsauner MJ, Michaelides I, Schmidt B, Scholz KJ, Buchalla W, Widbiller M, Hitzenbichler F, Ettl T, Reichert TE, Bohr C, Vielsmeier V, Cieplik F. A prospective clinical pilot study on the effects of a hydrogen peroxide mouthrinse on the intraoral viral load of SARS-CoV-2. Clin Oral Investig. 2020 Oct;24(10):3707-3713. doi: 10.1007/s00784-020-03549-1. Epub 2020 Sep 2.
Background: PubMed 3422246Gusberti FA, Sampathkumar P, Siegrist BE, Lang NP. Microbiological and clinical effects of chlorhexidine digluconate and hydrogen peroxide mouthrinses on developing plaque and gingivitis. J Clin Periodontol. 1988 Jan;15(1):60-7. doi: 10.1111/j.1600-051x.1988.tb01556.x.
Background: PubMed 21356027Hossainian N, Slot DE, Afennich F, Van der Weijden GA. The effects of hydrogen peroxide mouthwashes on the prevention of plaque and gingival inflammation: a systematic review. Int J Dent Hyg. 2011 Aug;9(3):171-81. doi: 10.1111/j.1601-5037.2010.00492.x. Epub 2011 Jan 31.
Background: PubMed 32035997Kampf G, Todt D, Pfaender S, Steinmann E. Persistence of coronaviruses on inanimate surfaces and their inactivation with biocidal agents. J Hosp Infect. 2020 Mar;104(3):246-251. doi: 10.1016/j.jhin.2020.01.022. Epub 2020 Feb 6.
Background: PubMed 32562846Kronbichler A, Kresse D, Yoon S, Lee KH, Effenberger M, Shin JI. Asymptomatic patients as a source of COVID-19 infections: A systematic review and meta-analysis. Int J Infect Dis. 2020 Sep;98:180-186. doi: 10.1016/j.ijid.2020.06.052. Epub 2020 Jun 17.
Background: PubMed 31761015Marui VC, Souto MLS, Rovai ES, Romito GA, Chambrone L, Pannuti CM. Efficacy of preprocedural mouthrinses in the reduction of microorganisms in aerosol: A systematic review. J Am Dent Assoc. 2019 Dec;150(12):1015-1026.e1. doi: 10.1016/j.adaj.2019.06.024.
Efficacy of three antimicrobial mouthwashes in reducing SARS-CoV-2 viral load in the saliva of hospitalized patients: a randomized controlled pilot studyLink provided by the sponsor.
Individual participant dataSharing planned: No. Aggregated/collective data regarding the efficacy of the different mouthwashes will be shared with the scientific community as a de-identified/coded information

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Prof Nikos Donos, PhD principal investigator

Queen Mary University London

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Viral load changes in the saliva within groups (time frame: 30 minutes, 1, 2 and 3 hours after mouth rinsing or no rinsing.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04723446, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.