Back to resultsThe Efficacy of Oral Antiseptics Against COVID-19
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Hypochlorous Acid 0.02% Soln,Top (Crystaline) (HClO)
Sponsored by
About this trial
This is an interventional supportive care trial for COVID-19 focused on measuring COVID-19, Viral load, Antiseptic, Povidone-iodine, Hypochlorous acid
Eligibility Criteria
Inclusion Criteria:
- Positive SARS-CoV-2 RT-PCR result,
- Adult hospitalized patient,
- The participants have the physical and psychological ability to follow the instructions in the study.
Exclusion Criteria:
- Patients intubated and supported by a mechanical respirator,
- Severe acute or chronic medical or psychiatric condition,
- History of significant adverse effects following use of oral hygiene products such as toothpaste and mouth rinses,
- Active uncontrolled thyroid disease,
- Developmental/cognitive disability,
- Pregnancy,
- Undergoing radioactive iodine therapy.
Sites / Locations
- Atatürk University Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Hypochlorous acid group
Povidone-iodine group
Saline group
Arm Description
The effect of 0.02% Hypochlorous acid solution on viral load was investigated by using 25 COVID-19 patients as an oral antiseptic for 30 seconds.
The effect on viral load was investigated by using 0.5% Povidone-iodine solution as an oral antiseptic for 30 seconds in 25 COVID-19 patients.
The effect on viral load was investigated by using 0.9% isotonic saline solution as a placebo for 30 seconds in 25 COVID-19 patients.
Outcomes
Primary Outcome Measures
RT-PCR analysis
For the quantitative analysis of the amount of SARS-CoV-2 RNA in the obtained samples, the Real-time Reverse Transcyptase Polymerase Chain Reaction method was used.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05214196
Brief Title
The Efficacy of Oral Antiseptics Against COVID-19
Official Title
The Effectiveness of Oral Antiseptics on the Intraoral Viral Load of SARS-CoV-2
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In a study conducted on 75 COVID-19 patients, the effect of SARS-CoV-2 on viral load was investigated as a result of the use of hypochlorous acid and povidone-iodine as an oral antiseptic.
Detailed Description
Before and 30 minutes after rinsing with mouth antiseptics, the participants were asked to rinse the mouth and throat for 30 seconds with 0.9% isotonic saline. The sample was sputtered into a sterile plastic container. The participants were grouped according to the type of oral antiseptics used. The effectiveness of SARS-CoV-2 viral load was investigated by rinsing the mouth and throat for 30 seconds with 20 ml of hypochlorous acid, povidone-iodine, and isotonic saline. Viral load was analyzed by RT-PCR analysis. The results were evaluated by statistical analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Viral load, Antiseptic, Povidone-iodine, Hypochlorous acid
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypochlorous acid group
Arm Type
Experimental
Arm Description
The effect of 0.02% Hypochlorous acid solution on viral load was investigated by using 25 COVID-19 patients as an oral antiseptic for 30 seconds.
Arm Title
Povidone-iodine group
Arm Type
Active Comparator
Arm Description
The effect on viral load was investigated by using 0.5% Povidone-iodine solution as an oral antiseptic for 30 seconds in 25 COVID-19 patients.
Arm Title
Saline group
Arm Type
Placebo Comparator
Arm Description
The effect on viral load was investigated by using 0.9% isotonic saline solution as a placebo for 30 seconds in 25 COVID-19 patients.
Intervention Type
Drug
Intervention Name(s)
Hypochlorous Acid 0.02% Soln,Top (Crystaline) (HClO)
Other Intervention Name(s)
Povidone-iodine 0.5% (Betadine) (PVP-I), Isotonic saline 0.9% (Gifrer)
Intervention Description
SARS-CoV-2 sample was obtained from COVID-19 patients by rinsing the mouth and throat with 5 ml of isotonic saline before and 30 minutes after rinsing. In the hypochlorous acid group, 20 ml of HClO was asked to be rinsed in the mouth and throat for 30 seconds in 25 participants. In the povidone-iodine group, 20 ml of PVP-I was asked to be rinsed in the mouth and throat for 30 seconds in 25 participants. In the saline group, 20 ml of saline was asked to be rinsed in the mouth and throat for 30 seconds in 25 participants.
Primary Outcome Measure Information:
Title
RT-PCR analysis
Description
For the quantitative analysis of the amount of SARS-CoV-2 RNA in the obtained samples, the Real-time Reverse Transcyptase Polymerase Chain Reaction method was used.
Time Frame
two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Positive SARS-CoV-2 RT-PCR result,
Adult hospitalized patient,
The participants have the physical and psychological ability to follow the instructions in the study.
Exclusion Criteria:
Patients intubated and supported by a mechanical respirator,
Severe acute or chronic medical or psychiatric condition,
History of significant adverse effects following use of oral hygiene products such as toothpaste and mouth rinses,
Active uncontrolled thyroid disease,
Developmental/cognitive disability,
Pregnancy,
Undergoing radioactive iodine therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alparslan Dilsiz, Prof.
Organizational Affiliation
Atatürk University, Faculty of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atatürk University Faculty of Dentistry
City
Erzurum
ZIP/Postal Code
25240
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy of Oral Antiseptics Against COVID-19
We'll reach out to this number within 24 hrs