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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - 30 COVID-19 patients aged ≥ 18 years old receiving the investigational drug | Active Comparator | Group 1 - 30 COVID-19 patients receiving standard therapy and the investigational drug (Virgin Coconut Oil) |
|
| Group 2 - 30 COVID-19 patients aged ≥ 18 years old receiving placebo | Placebo Comparator | Group 2 - 30 COVID-19 patients receiving standard therapy and placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| virgin coconut oil (VCO) | Drug | 15 mL of VCO twice a day for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ordinal 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) | 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 | 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) | 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. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Laboratory outcome of leucocyte count | leucocyte count, measured in 1000/micro liter | 14 days |
| Laboratory outcome of lymphocyte count | lymphocyte count, measured in percentage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ika Trisnawati, MD, MSc, internist | Contact | 6281228282801 | ika.trisnawati@ugm.ac.id |
| Name | Affiliation | Role |
|---|---|---|
| Ika Trisnawati, MD, MSc, internist | Gadjah Mada University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Public Hospital Dr. Sardjito | Recruiting | Yogyakarta | Indonesia |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D008900 | Mineral Waters |
| ID | Term |
|---|---|
| D014867 | Water |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 |
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The COVID-19 patients are recruited according to the inclusion and exclusion criteria, then divided 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.
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The participants and care provider are blinded to the type of treatment that the participants receive.
| placebo | Other | 15 mL of placebo twice a day for 14 days |
|
|
| 14 days |
| Laboratory outcome of neutrophil count | Neutrophil count, measured in percentage | 14 days |
| Laboratory outcome of neutrophil to lymphocyte ratio, in scale | neutrophil to lymphocyte ratio, in scale | 14 days |
| Laboratory outcome of D-dimer | D-dimer measured in microgram/Liter | 14 days |
| Laboratory outcome of TNF-alpha | TNF-alpha, measured in pg/ml | 14 days |
| Laboratory outcome of CRP value | CRP value measured in qualitative value | 14 days |
| Laboratory outcome of IL-6 | IL-6 value measured in pg/ml | 14 days |
| Laboratory outcome of ferritin | Ferritin value measured in mcg/liter | 14 days |
| Laboratory outcome of procalcitonin | procalcitonin in microgram/liter | 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 | 14 days |
| RSUD Wonosari | Recruiting | Yogyakarta | Indonesia |
|
| RSUP Sleman | Recruiting | Yogyakarta | Indonesia |
|
| Teaching Hospital of Universitas Gadjah Mada (UGM) | Recruiting | Yogyakarta | Indonesia |
|
| D007239 |
| Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |