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

Phase 2

Completed

• Conditions: COVID-19
• Interventions: Drug: Essential oils; Other: Tap water; Drug: Povidone-Iodine

• Registration Number: NCT04410159
• Lead Sponsor: Universiti Sains Islam Malaysia

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-05-27
• Study First Submitted QC: 2020-05-28
• Study First Posted: 2020-06-01
• Study Start: 2020-06-22
• Primary Completion: 2020-06-29
• Status Verified: 2020-07
• Study Completion: 2020-07-06
• Results First Submitted: 2020-07-08
• Results First Submitted QC: 2020-07-17
• Last Update Submitted: 2020-07-17
• Results First Posted: 2020-07-21
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Essential Oils	Essential oils	gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days
Tap water	Tap water	gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days
Povidone-iodine	Povidone-Iodine	gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days

Primary Outcome Measures

Name	Time	Method
Number of Participants With Early Viral Clearance	Day 6	Viral clearance is defined as two negative RT-PCR (of swabs from oropharynx and nasopharynx) results at least 24 hours apart

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universiti Kebangsaan Malaysia Medical Centre; 🇲🇾 Bandar Tun Razak, Wilayah Persekutuan Kuala Lumpur, Malaysia