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| Name | Class |
|---|---|
| Universiti Kebangsaan Malaysia Medical Centre | OTHER |
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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.
Experimental plan
After consent is taken, all groups will be briefed regarding the study protocol separately.
Monitoring
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Povidone-iodine | Experimental | gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days |
|
| Essential Oils | Experimental | gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days |
|
| Tap water | Experimental | gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days |
|
| Control | No Intervention | This group will receive the standard treatment protocol without any additional intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povidone-Iodine | Drug | Gargle |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Negative RT-PCR Results | RT-PCR (swabs from oropharynx and nasopharynx) taken at day 12 | Day 12 |
| Number of Patients That Progress to More Severe Disease | Presence of signs and symptoms of more severe COVID19 Based symptoms diary and clinical evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| NURUL A MOHAMED | Universiti Sains Islam Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universiti Kebangsaan Malaysia Medical Centre | Bandar Tun Razak | Kuala Lumpur | 56000 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29633177 | Background | 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. | |
| 31414403 | Background | 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. |
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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
September to December 2020
email to drnurul@usim.edu.my
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No significant event occurred after enrollment
All patients were recruited 2 to 3 days after date of diagnosis (nasophryngeal swab postive for SARS-C0V-2. All patients were asymptomatic and admitted to the hospital for observation
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| ID | Title | Description |
|---|---|---|
| FG000 | Povidone-iodine | gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days Povidone-Iodine: Gargle |
| FG001 | Essential Oils | gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days Essential oils: Gargle |
| FG002 | Tap Water | gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days Tap water: Gargle |
| FG003 | Control | This group will receive the standard treatment protocol without any additional intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Povidone-iodine | gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days Povidone-Iodine: Gargle |
| BG001 | Essential Oils | gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days Essential oils: Gargle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Day 6 |
|
Adverse event data were collected from day 1 of intervention until day 14
Similar to clinicaltrial.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Povidone-iodine | gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days Povidone-Iodine: Gargle |
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Inadequate budget for laboratory test lead to small numbers of subjects analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| NURUL AZMAWATI MOHAMED | UNIVERSITI SAINS ISLAM MALAYSIA | +603 42892400 | 2417 | drnurul@usim.edu.my |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 1, 2020 | Jul 17, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D011206 | Povidone-Iodine |
| D009822 | Oils, Volatile |
| C057473 | Listerine |
| ID | Term |
|---|---|
| D007466 | Iodophors |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
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4 arms
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| Essential oils | Drug | Gargle |
|
|
| Tap water | Other | Gargle |
|
| Day 12 |
| Number of Patients With Abnormal Radiological Findings | abnormal chest x-ray or CT scan | Day 0-14 |
| Number of Patients With Abnormal Laboratory Findings | Abnormal absolute lymphocytic count Abnormal C-reactive protein | Day 0-14 |
| 7614202 | Background | 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. |
| 16242593 | Background | 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. |
| BG002 | Tap Water | gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days Tap water: Gargle |
| BG003 | Control | This group received the standard treatment protocol without any additional intervention |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days Tap water: Gargle |
| OG003 | Control | This group will receive the standard treatment protocol without any additional intervention |
|
|
| Secondary | Number of Participants With Negative RT-PCR Results | RT-PCR (swabs from oropharynx and nasopharynx) taken at day 12 | Posted | Count of Participants | Participants | Day 12 |
|
|
|
| Secondary | Number of Patients That Progress to More Severe Disease | Presence of signs and symptoms of more severe COVID19 Based symptoms diary and clinical evaluation | Posted | Count of Participants | Participants | Day 12 |
|
|
|
| Secondary | Number of Patients With Abnormal Radiological Findings | abnormal chest x-ray or CT scan | Posted | Count of Participants | Participants | Day 0-14 |
|
|
|
| Secondary | Number of Patients With Abnormal Laboratory Findings | Abnormal absolute lymphocytic count Abnormal C-reactive protein | Posted | Count of Participants | Participants | Day 0-14 |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Essential Oils | gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days Essential oils: Gargle | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | Tap Water | gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days Tap water: Gargle | 0 | 5 | 0 | 5 | 0 | 5 |
| EG003 | Control | This group will receive the standard treatment protocol without any additional intervention | 0 | 5 | 0 | 5 | 0 | 5 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D014753 |
| Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D009821 | Oils |
| D008055 | Lipids |