Virgin Coconut Oil (VCO) as a Potential Adjuvant Therapy in COVID-19 Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Trial for the Benefit of Virgin Coconut Oil (VCO) as a Potential Adjuvant Therapy in COVID-19 Patients

Conditions
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Coronavirus Infections

Intervention / Treatment
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* Drug: virgin coconut oil (VCO)
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients, age ≥ 18 years old. COVID-19 patients diagnosed with nasopharyngeal/oropharyngeal PCR swab specimens that are treated in Central Public Hospital Dr. Sardjito, Teaching Hospital of Universitas Gadjah Mada (UGM), and Yogyakarta COVID-19 referral hospitals. Patients with mild and moderate pneumonia symptoms that are treated in Central Public Hospital Dr. Sardjito, Teaching Hospital of Universitas Gadjah Mada (UGM), and Yogyakarta COVID-19 referral hospitals. Exclusion Criteria: Patients with liver function disorder. VCO hypersensitivity. Patients with severe pneumonia and/or Acute Respiratory Distress Syndrome (ARDS). Pregnant patients. Patients with malignant comorbidity. Critical or unconscious patients. Patients using other immunomodulators similar to VCO within less than three days before VCO administration.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 - 30 COVID-19 patients aged ≥ 18 years old receiving the investigational drug<br>Group 1 - 30 COVID-19 patients receiving standard therapy and the investigational drug (Virgin Coconut Oil) | Drug: virgin coconut oil (VCO)<br>* 15 mL of VCO twice a day for 14 days<br>* Other names: virgin coconut oil;|
| Placebo Comparator: Group 2 - 30 COVID-19 patients aged ≥ 18 years old receiving placebo<br>Group 2 - 30 COVID-19 patients receiving standard therapy and placebo | Other: placebo<br>* 15 mL of placebo twice a day for 14 days<br>* Other names: mineral water;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, treatment, virgin coconut oil