COVID-19Phase 4NCT05214196
The Efficacy of Oral Antiseptics Against COVID-19
A Phase 4 study testing Hypochlorous Acid 0.02% Soln,Top (Crystaline) (HClO) in people with COVID-19, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Hypochlorous Acid 0.02% Soln,Top (Crystaline) (HClO)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 7 Dec 2021
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk University Faculty of Dentistry
Erzurum, 25240
About this study
Official title: The Effectiveness of Oral Antiseptics on the Intraoral Viral Load of SARS-CoV-2
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Hypochlorous Acid 0.02% Soln,Top (Crystaline) (HClO)
- Keywords
- COVID-19, Viral load, Antiseptic, Povidone-iodine, Hypochlorous acid
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypochlorous Acid 0.02% Soln,Top (Crystaline) (HClO)Drug
Also called Povidone-iodine 0.5% (Betadine) (PVP-I), Isotonic saline 0.9% (Gifrer)
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.
| Study group | Role | What they receive |
|---|---|---|
| Hypochlorous acid group | Experimental | 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. Receives: Drug: Hypochlorous Acid 0.02% Soln,Top (Crystaline) (HClO) |
| Povidone-iodine group | Active comparator | 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. Receives: Drug: Hypochlorous Acid 0.02% Soln,Top (Crystaline) (HClO) |
| Saline group | Placebo comparator | 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. Receives: Drug: Hypochlorous Acid 0.02% Soln,Top (Crystaline) (HClO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Sep 2021
- Primary completion1 Dec 2021
- Study completion7 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sema Nur Sevinc, Ataturk University
- Investigators
- Alparslan Dilsiz, Prof., Principal investigator, Atatürk University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214196
- Sponsor's protocol ID
- MIC1
- Status last verified
- Jan 2022
- First submitted
- 25 Jan 2022
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sevinc Gul SN, Dilsiz A, Saglik I, Aydin NN. Effect of oral antiseptics on the viral load of SARS-CoV-2: A randomized controlled trial. Dent Med Probl. 2022 Jul-Sep;59(3):357-363. doi: 10.17219/dmp/150831.
PubMed 35904769
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Oral Antiseptics on the Intraoral Viral Load of SARS-CoV-2
- ClinicalTrials.gov ID
- NCT05214196
- Acronym / sponsor ID
- MIC1
- Conditions
- COVID-19
- Keywords
- COVID-19, Viral load, Antiseptic, Povidone-iodine, Hypochlorous acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 7 Dec 2021 (actual)
- First posted
- 28 Jan 2022 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypochlorous acid group | Experimental | Drug: Hypochlorous Acid 0.02% Soln,Top (Crystaline) (HClO)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. |
| Povidone-iodine group | Active comparator | Drug: Hypochlorous Acid 0.02% Soln,Top (Crystaline) (HClO)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. |
| Saline group | Placebo comparator | Drug: Hypochlorous Acid 0.02% Soln,Top (Crystaline) (HClO)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
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 |
|---|---|---|
| Hypochlorous Acid 0.02% Soln,Top (Crystaline) (HClO)Also: Povidone-iodine 0.5% (Betadine) (PVP-I), Isotonic saline 0.9% (Gifrer)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. | Drug | Hypochlorous acid group, Povidone-iodine group, Saline group |
Primary outcome
RT-PCR analysis
Time frame: two weeks
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.
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 11 Feb 2022.
- Derived from this study: PubMed 35904769Sevinc Gul SN, Dilsiz A, Saglik I, Aydin NN. Effect of oral antiseptics on the viral load of SARS-CoV-2: A randomized controlled trial. Dent Med Probl. 2022 Jul-Sep;59(3):357-363. doi: 10.17219/dmp/150831.
- Individual participant dataSharing planned: No
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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.
Alparslan Dilsiz, Prof. principal investigator
Atatürk University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hypochlorous Acid 0.02% Soln,Top (Crystaline) (HClO) in people with COVID-19, run by Ataturk University at 1 site in Turkey (Türkiye).
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 3 inclusion and 7 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 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
RT-PCR analysis (time frame: two weeks). 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 NCT05214196, which also lists 1 linked publication.
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 11 Feb 2022.