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

Universiti Sains Islam Malaysia

Status and phase: Completed; Phase 2

Conditions: COVID-19

Treatments: Drug: Povidone-Iodine; Other: Tap water; Drug: Essential oils

Study type: Interventional

Funder types: Other

Identifiers

NCT04410159

USIMalaysia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

Povidone-iodine

Experimental group

Description:

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

Treatment:

Drug: Povidone-Iodine

Essential Oils

Experimental group

Description:

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

Treatment:

Drug: Essential oils

Tap water

Experimental group

Description:

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

Treatment:

Other: Tap water

Control

No Intervention group

Description:

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