COVID-19
Conditions
Keywords
gargle, povidone-iodine, essential oils, tap water
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.
Interventions
Sponsors
Universiti Kebangsaan Malaysia Medical Centre
Universiti Sains Islam Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
4 arms 1. Gargle with povidone-iodine 2. Gargle with essential oils 3. Gargle with tap water 4. Control
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Malaysia
Participant flow
Recruitment details
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
Pre-assignment details
No significant event occurred after enrollment
Participants by arm
| Arm | Count |
|---|---|
| Povidone-iodine gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days
Povidone-Iodine: Gargle | 5 |
| Essential Oils gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days
Essential oils: Gargle | 5 |
| Tap Water gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days
Tap water: Gargle | 5 |
| Control This group received the standard treatment protocol without any additional intervention | 5 |
| Total | 20 |
Baseline characteristics
| Characteristic | Essential Oils | Tap Water | Control | Povidone-iodine | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 20 Participants |
| Age, Continuous | 34.4 years STANDARD_DEVIATION 12.5 | 30.8 years STANDARD_DEVIATION 3.77 | 24.8 years STANDARD_DEVIATION 2.68 | 32.4 years STANDARD_DEVIATION 7.44 | 30.6 years STANDARD_DEVIATION 7.91 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 20 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Malaysia | 5 participants | 5 participants | 5 participants | 5 participants | 20 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 0 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 5 Participants | 2 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 |
Outcome results
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
Time frame: Day 6
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Povidone-iodine | Number of Participants With Early Viral Clearance | 5 Participants |
| Essential Oils | Number of Participants With Early Viral Clearance | 4 Participants |
| Tap Water | Number of Participants With Early Viral Clearance | 1 Participants |
| Control | Number of Participants With Early Viral Clearance | 0 Participants |
Secondary
Number of Participants With Negative RT-PCR Results
RT-PCR (swabs from oropharynx and nasopharynx) taken at day 12
Time frame: Day 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Povidone-iodine | Number of Participants With Negative RT-PCR Results | 5 Participants |
| Essential Oils | Number of Participants With Negative RT-PCR Results | 4 Participants |
| Tap Water | Number of Participants With Negative RT-PCR Results | 2 Participants |
| Control | Number of Participants With Negative RT-PCR Results | 1 Participants |
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
Time frame: Day 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Povidone-iodine | Number of Patients That Progress to More Severe Disease | 0 Participants |
| Essential Oils | Number of Patients That Progress to More Severe Disease | 0 Participants |
| Tap Water | Number of Patients That Progress to More Severe Disease | 0 Participants |
| Control | Number of Patients That Progress to More Severe Disease | 0 Participants |
Secondary
Number of Patients With Abnormal Laboratory Findings
Abnormal absolute lymphocytic count Abnormal C-reactive protein
Time frame: Day 0-14
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Povidone-iodine | Number of Patients With Abnormal Laboratory Findings | 0 Participants |
| Essential Oils | Number of Patients With Abnormal Laboratory Findings | 0 Participants |
| Tap Water | Number of Patients With Abnormal Laboratory Findings | 0 Participants |
| Control | Number of Patients With Abnormal Laboratory Findings | 0 Participants |
Secondary
Number of Patients With Abnormal Radiological Findings
abnormal chest x-ray or CT scan
Time frame: Day 0-14
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Povidone-iodine | Number of Patients With Abnormal Radiological Findings | 0 Participants |
| Essential Oils | Number of Patients With Abnormal Radiological Findings | 0 Participants |
| Tap Water | Number of Patients With Abnormal Radiological Findings | 0 Participants |
| Control | Number of Patients With Abnormal Radiological Findings | 0 Participants |