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

COVID-19 Clinical Trial

— GARGLES  

Official title:

A Pilot, Open-Labelled, Randomised Controlled Trial Of Povidone-Iodine Vs Essential Oil And Tap Water Gargling For COVID-19 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04410159
• Other study ID #: USIMalaysia
• Status: Completed
• Phase: Phase 2
• Start date: June 22, 2020
• Est. completion date: July 6, 2020

Study information

• Verified date: July 2020
• Source: Universiti Sains Islam Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Experimental plan

After consent is taken, all groups will be briefed regarding the study protocol separately.

• Group A will be briefed on the correct procedures of gargling with Betadine®. The participants will be instructed to take 10ml of povidone-iodine (PVP-I), tilt their heads backward and gargle for 30 seconds, three times per day for 7 days

• Group B will be briefed on the correct technique of gargling with Listerine®. The participants will be instructed to take 20ml of essential oils, tilt their heads backward and gargle for 30 seconds, three times per day for 7 days

• Group C will be briefed on the correct technique of gargling with hydrogen peroxide. The participants will be instructed to take 10ml of hydrogen peroxide, tilt their heads backward and gargle for 30 seconds, three times per day for 7 days

• Group D will be briefed about the involvement in this study. They will be managed according to the standard protocol of the hospital with no additional intervention.

Monitoring

1. Oropharyngeal and nasopharyngeal swabs will be taken on day 4, 6 of intervention, and day 12 post-intervention. The swabs will be subjected to detection of SARS-CoV-2 by real-time reverse transcriptase-polymerase chain reaction (rt RT-PCR).

2. Patients will be given a chart for them to record their gargling practice and symptoms (if any) during the intervention period ( 7 days)

3. Clinical data collection sheet will be provided to attending clinicians. The required information includes demographic data, daily vital signs, serial absolute lymphocytic count, LDH, chest radiograph, and symptoms. Clinical monitoring will be done until day 14 of the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 6, 2020
• Est. primary completion date: June 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. adult aged 18 years and above

2. able to understand instructions

3. Stage 1 COVID-19

4. < 5 days of illness or diagnosis

Exclusion Criteria:

1. Less than 18 years old

2. Unable to understand instructions

3. Stage 2 & 3 COVID-19

4. Respiratory symptoms or fever on admission

5. Abnormal chest radiograph or computed tomography (CT) findings on admission

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Povidone-Iodine
Gargle
• Essential oils
Gargle

Other:
• Tap water
Gargle

Locations

Country	Name	City	State
Malaysia	Universiti Kebangsaan Malaysia Medical Centre	Bandar Tun Razak	Wilayah Persekutuan Kuala Lumpur

Sponsors (2)

Lead Sponsor	Collaborator
Universiti Sains Islam Malaysia	Universiti Kebangsaan Malaysia Medical Centre

Country where clinical trial is conducted

Malaysia, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. Review. Erratum in: Infect Dis Ther. 2019 Aug 22;:. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Negative RT-PCR Results	RT-PCR (swabs from oropharynx and nasopharynx) taken at day 12	Day 12
Secondary	Number of Patients That Progress to More Severe Disease	Presence of signs and symptoms of more severe COVID19 Based symptoms diary and clinical evaluation	Day 12
Secondary	Number of Patients With Abnormal Radiological Findings	abnormal chest x-ray or CT scan	Day 0-14
Secondary	Number of Patients With Abnormal Laboratory Findings	Abnormal absolute lymphocytic count Abnormal C-reactive protein	Day 0-14