NCT05214196

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P25-P50 for phase_4 covid19

Timeline
Completed

Started Sep 2021

Shorter than P25 for phase_4 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
Last Updated

February 11, 2022

Status Verified

January 1, 2022

Enrollment Period

3 months

First QC Date

January 25, 2022

Last Update Submit

January 28, 2022

Conditions

COVID-19

Keywords

COVID-19Viral loadAntisepticPovidone-iodineHypochlorous acid

Outcome Measures

Primary Outcomes (1)

  • 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.

    two weeks

Study Arms (3)

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.

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.

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.

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

Interventions

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

Also known as: Povidone-iodine 0.5% (Betadine) (PVP-I), Isotonic saline 0.9% (Gifrer)
Hypochlorous acid groupPovidone-iodine groupSaline group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk University Faculty of Dentistry

Erzurum, 25240, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 35904769DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Hypochlorous AcidPovidone-IodineSodium Chloride

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acids, NoncarboxylicAcidsInorganic ChemicalsChlorine CompoundsReactive Oxygen SpeciesFree RadicalsOxidesOxygen CompoundsIodophorsIodine CompoundsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureChloridesHydrochloric AcidSodium Compounds

Study Officials

  • Alparslan Dilsiz, Prof.

    Atatürk University, Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 25, 2022

First Posted

January 28, 2022

Study Start

September 1, 2021

Primary Completion

December 1, 2021

Study Completion

December 7, 2021

Last Updated

February 11, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)