Clinical pilot study on the effects of a hydrogen peroxide mouthrinse on the intraoral viral load of SARS-CoV-2 (COVID-19)
Organizational Data
- DRKS-ID:
- DRKS00022484
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2020-07-17
- Last update in DRKS:
- 2021-02-10
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
Several specialist societies have recommended to perform a hydrogen peroxide mouthrinse in SARS-CoV-2 positive patients in order to reduce the intraoral viral load of SARS-CoV-2. Until now, there are no clinical data justifying this recommendation. Therefore, the aim of this study was to investigate the effects of a hydrogen peroxide mouthrinse on reducing the intraoral viral load of SARS-CoV-2.
Brief summary in scientific language
Several specialist societies have recommended to perform a hydrogen peroxide mouthrinse in SARS-CoV-2 positive patients in order to reduce the intraoral viral load of SARS-CoV-2. Until now, there are no clinical data justifying this recommendation. Therefore, the aim of this study was to investigate the effects of a hydrogen peroxide mouthrinse on reducing the intraoral viral load of SARS-CoV-2. First, the current intraoral load is determined in SARS-CoV-2 positive patients by obtaining oropharyngeal specimens and RT-PCR analysis. Then, patients are asked to thoroughly gargle their mouth and throat with 20 mL 1% hydrogen peroxide for 30 seconds. Thirty minutes after this mouthrinse, another oropharyngeal specimen is obtained and SARS-CoV-2 viral load is determined by RT-PCR.
Health condition or problem studied
- Free text:
- U07 COVID-19
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- First, the current intraoral load is determined in SARS-CoV-2 positive patients by obtaining oropharyngeal specimens and RT-PCR analysis. Then, patients are asked to thoroughly gargle their mouth and throat with 20 mL 1% hydrogen peroxide for 30 seconds. Thirty minutes after this mouthrinse, another oropharyngeal specimen is obtained and SARS-CoV-2 viral load is determined by RT-PCR.
Endpoints
- Primary outcome:
- Reduction of the intraoral SARS-CoV-2 viral load (measurements immediately before gargling with hydrogen peroxide and 30 min after gargling with hydrogen peroxide by RT-PCR)
- Secondary outcome:
- No Entry
Study Design
- Purpose:
- Prevention
- Allocation:
- N/A (single arm study)
- Control:
-
- Uncontrolled/single arm
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Single (group)
- Sequence generation:
- No Entry
- Who is blinded:
-
- Assessor
- Data analyst
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Regensburg
Recruitment period and number of participants
- Planned study start date:
- 2020-04-09
- Actual study start date:
- 2020-04-09
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2020-07-31
- Target Sample Size:
- 50
- Final Sample Size:
- 12
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- no minimum age
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- - hospitalized patients (isolation ward of the University Hospital Regensburg) - positive SARS-CoV-2 test within the last 72 h
Exclusion Criteria
- indication for intubation or mechanical ventilation - severe stomatitis
Addresses
Primary Sponsor
- Address:
- Poliklinik für Zahnerhaltung und ParodontologieUniversitätsklinikum RegensburgPriv.-Doz. Dr. Fabian CieplikFranz-Josef-Strauß-Allee 1193053 RegensburgGermany
- Telephone:
- 0941 944 6024
- Fax:
- 0941 944 6025
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ukr.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Poliklinik für Zahnerhaltung und ParodontologieUniversitätsklinikum RegensburgPriv.-Doz. Dr. Fabian CieplikFranz-Josef-Strauß-Allee 1193053 RegensburgGermany
- Telephone:
- 0941 944 6024
- Fax:
- 0941 944 6025
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ukr.de
Contact for Public Queries
- Address:
- Poliklinik für Zahnerhaltung und ParodontologieUniversitätsklinikum RegensburgPriv.-Doz. Dr. Fabian CieplikFranz-Josef-Strauß-Allee 1193053 RegensburgGermany
- Telephone:
- 0941 944 6024
- Fax:
- 0941 944 6025
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ukr.de
Principal Investigator
- Address:
- Poliklinik für Zahnerhaltung und ParodontologieUniversitätsklinikum RegensburgPriv.-Doz. Dr. Fabian CieplikFranz-Josef-Strauß-Allee 1193053 RegensburgGermany
- Telephone:
- 0941 944 6024
- Fax:
- 0941 944 6025
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ukr.de
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsklinikum RegensburgFranz-Josef-Strauss-Allee 1193053 RegensburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinikum-regensburg.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Universität RegensburgLandshuter Straße 493047 RegensburgGermany
- Telephone:
- +49-941-9435370
- Fax:
- +49-941-9435369
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2020-04-08
- Ethics committee number:
- 20-1787-101
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-04-09
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry