The Efficacy of Oral Antiseptics Against COVID-19

NCT ID: NCT05214196

Last Updated: 2022-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2021-12-07

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Hypochlorous acid group

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.

Group Type: EXPERIMENTAL

Hypochlorous Acid 0.02% Soln,Top (Crystaline) (HClO)

Intervention Type: DRUG

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.

Povidone-iodine group

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.

Group Type: ACTIVE_COMPARATOR

Hypochlorous Acid 0.02% Soln,Top (Crystaline) (HClO)

Intervention Type: DRUG

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.

Saline group

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.

Group Type: PLACEBO_COMPARATOR

Hypochlorous Acid 0.02% Soln,Top (Crystaline) (HClO)

Intervention Type: DRUG

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.

Interventions

Hypochlorous Acid 0.02% Soln,Top (Crystaline) (HClO)

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.

Intervention Type: DRUG

Other Intervention Names

Povidone-iodine 0.5% (Betadine) (PVP-I); Isotonic saline 0.9% (Gifrer)

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

Sema Nur Sevinc

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alparslan Dilsiz, Prof.

Role: PRINCIPAL_INVESTIGATOR

Atatürk University, Faculty of Dentistry

Locations

Atatürk University Faculty of Dentistry

Erzurum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 35904769 (View on PubMed)

Other Identifiers

MIC1

Identifier Type: -

Identifier Source: org_study_id