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

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ClinicalTrials.gov Identifier: NCT04410159
Recruitment Status : Completed
First Posted : June 1, 2020
Results First Posted : July 21, 2020
Last Update Posted : July 21, 2020
Sponsor:
Collaborator:
Universiti Kebangsaan Malaysia Medical Centre
Information provided by (Responsible Party):
NURUL AZMAWATI MOHAMED, Universiti Sains Islam Malaysia

Study Description
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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.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: Povidone-Iodine Drug: Essential oils Other: Tap water Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

4 arms

  1. Gargle with povidone-iodine
  2. Gargle with essential oils
  3. Gargle with tap water
  4. Control
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot, Open-Labelled, Randomised Controlled Trial Of Povidone-Iodine Vs Essential Oil And Tap Water Gargling For COVID-19 Patients
Actual Study Start Date : June 22, 2020
Actual Primary Completion Date : June 29, 2020
Actual Study Completion Date : July 6, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arms and Interventions
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Arm Intervention/treatment
Experimental: Povidone-iodine
gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days
 Drug: Povidone-Iodine
Gargle
Other Name: Betadine
Experimental: Essential Oils
gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days
 Drug: Essential oils
Gargle
Other Name: Listerine
Experimental: Tap water
gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days
 Other: Tap water
Gargle
No Intervention: Control
This group will receive the standard treatment protocol without any additional intervention


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Early Viral Clearance [ Time Frame: 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 :
  1. Number of Participants With Negative RT-PCR Results [ Time Frame: Day 12 ]
    RT-PCR (swabs from oropharynx and nasopharynx) taken at day 12

  2. Number of Patients That Progress to More Severe Disease [ Time Frame: Day 12 ]
    Presence of signs and symptoms of more severe COVID19 Based symptoms diary and clinical evaluation

  3. Number of Patients With Abnormal Radiological Findings [ Time Frame: Day 0-14 ]
    abnormal chest x-ray or CT scan

  4. Number of Patients With Abnormal Laboratory Findings [ Time Frame: Day 0-14 ]
    Abnormal absolute lymphocytic count Abnormal C-reactive protein


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04410159


Locations
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Malaysia
Universiti Kebangsaan Malaysia Medical Centre
Bandar Tun Razak, Wilayah Persekutuan Kuala Lumpur, Malaysia, 56000
Sponsors and Collaborators
Universiti Sains Islam Malaysia
Universiti Kebangsaan Malaysia Medical Centre
Investigators
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Principal Investigator: NURUL A MOHAMED Universiti Sains Islam Malaysia
  Study Documents (Full-Text)

Documents provided by NURUL AZMAWATI MOHAMED, Universiti Sains Islam Malaysia:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] May 1, 2020

More Information
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Publications:

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Responsible Party: NURUL AZMAWATI MOHAMED, Dr, Universiti Sains Islam Malaysia
ClinicalTrials.gov Identifier: NCT04410159    
Other Study ID Numbers: USIMalaysia
First Posted: June 1, 2020    Key Record Dates
Results First Posted: July 21, 2020
Last Update Posted: July 21, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The participant data from the final research dataset used in the published manuscript will be shared upon reasonable request. The protocol and data analysis will be shared in clinicaltrial
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: September to December 2020
Access Criteria: email to drnurul@usim.edu.my

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NURUL AZMAWATI MOHAMED, Universiti Sains Islam Malaysia:
gargle
povidone-iodine
essential oils
tap water
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
 Lung Diseases
Respiratory Tract Diseases
Povidone-Iodine
Listerine
Povidone
Plasma Substitutes
Blood Substitutes
Anti-Infective Agents, Local
Anti-Infective Agents