Clinical trial NCT04410159: Povidone-Iodine Vs Essential Oil Vs Tap Water Gargling For COVID-19 Patients
Official title: A Pilot, Open-Labelled, Randomised Controlled Trial Of Povidone-Iodine Vs Essential Oil And Tap Water Gargling For COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: gargle
povidone-iodine
essential oils
tap water
Lead sponsor: Universiti Sains Islam Malaysia
Sponsor class: OTHER
Collaborators: name: Universiti Kebangsaan Malaysia Medical Centre
First posted: 2020-06-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4 arms

1. Gargle with povidone-iodine
2. Gargle with essential oils
3. Gargle with tap water
4. Control
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Early Viral Clearance
timeFrame: Day 6
Secondary outcomes:
measure: Number of Participants With Negative RT-PCR Results
timeFrame: Day 12
measure: Number of Patients That Progress to More Severe Disease
timeFrame: Day 12
measure: Number of Patients With Abnormal Radiological Findings
timeFrame: Day 0-14
measure: Number of Patients With Abnormal Laboratory Findings
timeFrame: Day 0-14
Other outcomes:
Locations:
city: Bandar Tun Razak
country: Malaysia
facility: Universiti Kebangsaan Malaysia Medical Centre
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
affiliation: Universiti Sains Islam Malaysia
name: NURUL A MOHAMED
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.