Virgin Coconut Oil (VCO) contains multiple compounds which have antibacterial, antiviral, and immunomodulatory properties. The role of VCO as an antivirus to treat COVID-19 requires further studies. A previous study has investigated the used of 30 ml of VCO to healthy volunteers for a month and reported no side effect. Here the investigators conduct a pilot trial to investigate the effect of VCO towards the clinical outcomes of COVID-19 patients in Indonesia.
The subjects of this pilot study are patients diagnosed with COVID-19 in Central Public Hospital Dr. Sardjito, Teaching Hospital of Universitas Gadjah Mada (UGM), and Yogyakarta COVID-19 referral hospitals (RSUD Wonosari and Sleman). The COVID-19 patients are recruited according to the inclusion and exclusion criteria, then divided randomly into two groups. Group I, the intervention group, consists of COVID-19 patients receiving standard therapy and 15 mL of VCO twice a day for 14 days. Group II, the control group, consists of COVID-19 patients receiving standard therapy and 15 mL of placebo twice a day for 14 days. Both groups are monitored for four weeks with a nasopharyngeal or oropharyngeal Polymerase Chain Reaction (PCR) swab test.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
15 mL of VCO twice a day for 14 days
15 mL of placebo twice a day for 14 days
Central Public Hospital Dr. Sardjito
Yogyakarta, Indonesia
RECRUITINGRSUD Wonosari
Yogyakarta, Indonesia
RECRUITINGRSUP Sleman
Yogyakarta, Indonesia
RECRUITINGOrdinal scale for measuring clinical improvement by the World Health Organization (WHO)
Clinical improvement determined by the World Health Organization (WHO) in ordinal scale (0-8)
Time frame: 14 days
Clinical symptoms improvement, determined with interview and examination
Duration of symptoms (fever, respiratory rate or shortness of breath, and cough) that is calculated according to the start of VCO or placebo administration until symptoms disappear, obtained based on anamnesis and physical examination
Time frame: 14 days
Pain as side effects of the drugs, measured by Visual Analog Scale
Probable side effects of the virgin coconut oil, i.e. headache, stomachache, muscle pain, measured in Visual Analog Scale (0-10)
Time frame: 14 days
Allergic reaction severity in mild, moderate, or severe
Probable side effects of the virgin coconut oil, i.e. allergic reaction severity, categorized in mild, moderate, or severe reaction.
Time frame: 14 days
Laboratory outcome of leucocyte count
leucocyte count, measured in 1000/micro liter
Time frame: 14 days
Laboratory outcome of lymphocyte count
lymphocyte count, measured in percentage
Time frame: 14 days
Laboratory outcome of neutrophil count
Neutrophil count, measured in percentage
Time frame: 14 days
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Teaching Hospital of Universitas Gadjah Mada (UGM)
Yogyakarta, Indonesia
RECRUITINGLaboratory outcome of neutrophil to lymphocyte ratio, in scale
neutrophil to lymphocyte ratio, in scale
Time frame: 14 days
Laboratory outcome of D-dimer
D-dimer measured in microgram/Liter
Time frame: 14 days
Laboratory outcome of TNF-alpha
TNF-alpha, measured in pg/ml
Time frame: 14 days
Laboratory outcome of CRP value
CRP value measured in qualitative value
Time frame: 14 days
Laboratory outcome of IL-6
IL-6 value measured in pg/ml
Time frame: 14 days
Laboratory outcome of ferritin
Ferritin value measured in mcg/liter
Time frame: 14 days
Laboratory outcome of procalcitonin
procalcitonin in microgram/liter
Time frame: 14 days
chest radiology outcome, measured as improvement of infiltrate based on expert assessment
chest radiology outcome, measured as improvement of infiltrate based on expert assessment in day 1 and 14
Time frame: 14 days