Coronavirus Infections
Conditions
Keywords
COVID-19, treatment, virgin coconut oil
Brief summary
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
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.
Interventions
15 mL of VCO twice a day for 14 days
OTHERplacebo
15 mL of placebo twice a day for 14 days
Sponsors
Gadjah Mada University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
The participants and care provider are blinded to the type of treatment that the participants receive.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ordinal scale for measuring clinical improvement by the World Health Organization (WHO) | 14 days | Clinical improvement determined by the World Health Organization (WHO) in ordinal scale (0-8) |
| Clinical symptoms improvement, determined with interview and examination | 14 days | 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 |
| Pain as side effects of the drugs, measured by Visual Analog Scale | 14 days | Probable side effects of the virgin coconut oil, i.e. headache, stomachache, muscle pain, measured in Visual Analog Scale (0-10) |
| Allergic reaction severity in mild, moderate, or severe | 14 days | Probable side effects of the virgin coconut oil, i.e. allergic reaction severity, categorized in mild, moderate, or severe reaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Laboratory outcome of neutrophil to lymphocyte ratio, in scale | 14 days | neutrophil to lymphocyte ratio, in scale |
| Laboratory outcome of D-dimer | 14 days | D-dimer measured in microgram/Liter |
| Laboratory outcome of CRP value | 14 days | CRP value measured in qualitative value |
| Laboratory outcome of TNF-alpha | 14 days | TNF-alpha, measured in pg/ml |
| Laboratory outcome of ferritin | 14 days | Ferritin value measured in mcg/liter |
| Laboratory outcome of procalcitonin | 14 days | procalcitonin in microgram/liter |
| chest radiology outcome, measured as improvement of infiltrate based on expert assessment | 14 days | chest radiology outcome, measured as improvement of infiltrate based on expert assessment in day 1 and 14 |
| Laboratory outcome of IL-6 | 14 days | IL-6 value measured in pg/ml |
| Laboratory outcome of leucocyte count | 14 days | leucocyte count, measured in 1000/micro liter |
| Laboratory outcome of lymphocyte count | 14 days | lymphocyte count, measured in percentage |
| Laboratory outcome of neutrophil count | 14 days | Neutrophil count, measured in percentage |
Countries
Indonesia
Contacts
Primary ContactIka Trisnawati, MD, MSc, internist
Outcome results
None listed