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

Study Overview
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Brief Summary
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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.

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

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

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Povidone-Iodine
* Drug: Essential oils
* Other: Tap water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult aged 18 years and above able to understand instructions Stage 1 COVID-19 < 5 days of illness or diagnosis Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 4 arms Gargle with povidone-iodine Gargle with essential oils Gargle with tap water Control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Povidone-iodine<br>gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days | Drug: Povidone-Iodine<br>* Gargle<br>* Other names: Betadine;|
| Experimental: Essential Oils<br>gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days | Drug: Essential oils<br>* Gargle<br>* Other names: Listerine;|
| Experimental: Tap water<br>gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days | Other: Tap water<br>* Gargle<br>|
| No Intervention: Control<br>This group will receive the standard treatment protocol without any additional intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Negative RT-PCR Results | RT-PCR (swabs from oropharynx and nasopharynx) taken at day 12 | Day 12 | 
| 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 | 
| Number of Patients With Abnormal Radiological Findings | abnormal chest x-ray or CT scan | Day 0-14 | 
| Number of Patients With Abnormal Laboratory Findings | Abnormal absolute lymphocytic count Abnormal C-reactive protein | Day 0-14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gargle, povidone-iodine, essential oils, tap water