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. * 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Universiti Kebangsaan Malaysia Medical Centre
Bandar Tun Razak, Kuala Lumpur, Malaysia
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
Number of Participants With Negative RT-PCR Results
RT-PCR (swabs from oropharynx and nasopharynx) taken at day 12
Time frame: 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
Time frame: Day 12
Number of Patients With Abnormal Radiological Findings
abnormal chest x-ray or CT scan
Time frame: Day 0-14
Number of Patients With Abnormal Laboratory Findings
Abnormal absolute lymphocytic count Abnormal C-reactive protein
Time frame: Day 0-14
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