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COVID-19Phase 2GARGLESNCT04410159

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

A Phase 2 study testing Povidone-Iodine, Essential oils and Tap water in people with COVID-19, run by Universiti Sains Islam Malaysia at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
Povidone-Iodine, Essential oils and Tap water
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteMalaysia
Study dates
22 Jun 2020to 6 Jul 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adult aged 18 years and above
  • able to understand instructions
  • Stage 1 COVID-19
  • < 5 days of illness or diagnosis

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • Universiti Kebangsaan Malaysia Medical Centre

    Bandar Tun Razak, Kuala Lumpur, 56000

Other trials in Malaysia

About this study

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

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.

Read the 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.
Conditions
COVID-19
Being tested
Povidone-Iodine, Essential oils, Tap water
Keywords
gargle, povidone-iodine, essential oils, tap water
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Povidone-IodineDrug

    Also called Betadine

    Gargle

  • Essential oilsDrug

    Also called Listerine

    Gargle

  • Tap waterOther

    Gargle

Study groups in NCT04410159
Study groupRoleWhat they receive
Povidone-iodineExperimentalgargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days
Receives: Drug: Povidone-Iodine
Essential OilsExperimentalgargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days
Receives: Drug: Essential oils
Tap waterExperimentalgargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days
Receives: Other: Tap water
ControlNo interventionThis group will receive the standard treatment protocol without any additional intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Day 6

Secondary outcomes (4)

  1. Number of Participants With Negative RT-PCR Results

    RT-PCR (swabs from oropharynx and nasopharynx) taken at day 12

    Measured: Day 12

  2. Number of Patients That Progress to More Severe Disease

    Presence of signs and symptoms of more severe COVID19 Based symptoms diary and clinical evaluation

    Measured: Day 12

  3. Number of Patients With Abnormal Radiological Findings

    abnormal chest x-ray or CT scan

    Measured: Day 0-14

  4. Number of Patients With Abnormal Laboratory Findings

    Abnormal absolute lymphocytic count Abnormal C-reactive protein

    Measured: Day 0-14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2020
  2. Study start22 Jun 2020
  3. Primary completion29 Jun 2020
  4. Study completion6 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04410159
Sponsor's protocol ID
USIMalaysia
Acronym
GARGLES
Status last verified
Jul 2020
First submitted
27 May 2020
Last updated
21 Jul 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 29633177

  • 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.

    PubMed 31414403

  • 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. doi: 10.1016/s1079-2104(05)80124-6.

    PubMed 7614202

  • 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. doi: 10.1016/j.amepre.2005.06.013.

    PubMed 16242593

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Povidone-Iodine, Essential oils and Tap water in people with COVID-19, run by Universiti Sains Islam Malaysia at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Early Viral Clearance (time frame: Day 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04410159, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.

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