Povidone-Iodine Vs Essential Oil Vs Tap Water Gargling For COVID-19 Patients

NCT04410159 | Completed Phase 2 Results

• 1 other identifier: USIMalaysia
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the ability of regular gargling to eliminate severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the throat and nasopharynx. This 4 arms interventional study compares the effect of gargling using povidone-iodine, essential oils- based, tap water with control (no intervention) among Stage 1 coronavirus disease-2019 (COVID-19) patients. Findings from this study will provide new insight into the importance of gargling in the treatment and prevention of COVID-19.

Conditions

COVID-19

Keywords

gargle; povidone-iodine; essential oils; tap water

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Early Viral Clearance

  Viral clearance is defined as two negative RT-PCR (of swabs from oropharynx and nasopharynx) results at least 24 hours apart

  Day 6

Secondary Outcomes (4)

• Number of Participants With Negative RT-PCR Results

  Day 12

• Number of Patients That Progress to More Severe Disease

  Day 12

• Number of Patients With Abnormal Radiological Findings

  Day 0-14

• Number of Patients With Abnormal Laboratory Findings

  Day 0-14

Study Arms (4)

Povidone-iodine

EXPERIMENTAL

gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days

Drug: Povidone-Iodine

Essential Oils

EXPERIMENTAL

gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days

Drug: Essential oils

Tap water

EXPERIMENTAL

gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days

Other: Tap water

Control

NO INTERVENTION

This group will receive the standard treatment protocol without any additional intervention

Interventions

Povidone-Iodine DRUG

Gargle

Also known as: Betadine

Povidone-iodine

Essential oils DRUG

Gargle

Also known as: Listerine

Essential Oils

Tap water OTHER

Gargle

Tap water

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult aged 18 years and above
• able to understand instructions
• Stage 1 COVID-19
• \< 5 days of illness or diagnosis

You may not qualify if:

• Less than 18 years old
• Unable to understand instructions
• Stage 2 \& 3 COVID-19
• Respiratory symptoms or fever on admission
• Abnormal chest radiograph or computed tomography (CT) findings on admission

Sponsors & Collaborators

• Universiti Sains Islam Malaysia: lead
• Universiti Kebangsaan Malaysia Medical Centre: collaborator

Study Sites (1)

Universiti Kebangsaan Malaysia Medical Centre

Bandar Tun Razak, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (4)

• Eggers M, Koburger-Janssen T, Eickmann M, Zorn J. In Vitro Bactericidal and Virucidal Efficacy of Povidone-Iodine Gargle/Mouthwash Against Respiratory and Oral Tract Pathogens. Infect Dis Ther. 2018 Jun;7(2):249-259. doi: 10.1007/s40121-018-0200-7. Epub 2018 Apr 9.

  PMID: 29633177 BACKGROUND

• Eggers M. Infectious Disease Management and Control with Povidone Iodine. Infect Dis Ther. 2019 Dec;8(4):581-593. doi: 10.1007/s40121-019-00260-x. Epub 2019 Aug 14.

  PMID: 31414403 BACKGROUND

• Dennison DK, Meredith GM, Shillitoe EJ, Caffesse RG. The antiviral spectrum of Listerine antiseptic. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1995 Apr;79(4):442-8. doi: 10.1016/s1079-2104(05)80124-6.

  PMID: 7614202 BACKGROUND

• Satomura K, Kitamura T, Kawamura T, Shimbo T, Watanabe M, Kamei M, Takano Y, Tamakoshi A; Great Cold Investigators-I. Prevention of upper respiratory tract infections by gargling: a randomized trial. Am J Prev Med. 2005 Nov;29(4):302-7. doi: 10.1016/j.amepre.2005.06.013.

  PMID: 16242593 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Povidone-Iodine; Oils, Volatile; Listerine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Oils; Lipids

Limitations and Caveats

Inadequate budget for laboratory test lead to small numbers of subjects analyzed

Results Point of Contact

• Title: NURUL AZMAWATI MOHAMED
• Organization: UNIVERSITI SAINS ISLAM MALAYSIA

drnurul@usim.edu.my

+603 42892400

Study Officials

• NURUL A MOHAMED

  Universiti Sains Islam Malaysia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: 4 arms 1. Gargle with povidone-iodine 2. Gargle with essential oils 3. Gargle with tap water 4. Control

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 1, 2020
• Study Start: June 22, 2020
• Primary Completion: June 29, 2020
• Study Completion: July 6, 2020
• Last Updated: July 21, 2020
• Results First Posted: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: September to December 2020
• Access Criteria: email to drnurul@usim.edu.my

Locations

MY (1)