Clinical trial NCT04594330: Virgin Coconut Oil (VCO) as a Potential Adjuvant Therapy in COVID-19 Patients
Official title: Pilot Trial for the Benefit of Virgin Coconut Oil (VCO) as a Potential Adjuvant Therapy in COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Coronavirus Infections
Keywords: COVID-19
treatment
virgin coconut oil
Lead sponsor: Gadjah Mada University
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ordinal scale for measuring clinical improvement by the World Health Organization (WHO)
timeFrame: 14 days
measure: Clinical symptoms improvement, determined with interview and examination
timeFrame: 14 days
measure: Pain as side effects of the drugs, measured by Visual Analog Scale
timeFrame: 14 days
measure: Allergic reaction severity in mild, moderate, or severe
timeFrame: 14 days
Secondary outcomes:
measure: Laboratory outcome of leucocyte count
timeFrame: 14 days
measure: Laboratory outcome of lymphocyte count
timeFrame: 14 days
measure: Laboratory outcome of neutrophil count
timeFrame: 14 days
measure: Laboratory outcome of neutrophil to lymphocyte ratio, in scale
timeFrame: 14 days
measure: Laboratory outcome of D-dimer
timeFrame: 14 days
measure: Laboratory outcome of TNF-alpha
timeFrame: 14 days
measure: Laboratory outcome of CRP value
timeFrame: 14 days
measure: Laboratory outcome of IL-6
timeFrame: 14 days
measure: Laboratory outcome of ferritin
timeFrame: 14 days
measure: Laboratory outcome of procalcitonin
timeFrame: 14 days
measure: chest radiology outcome, measured as improvement of infiltrate based on expert assessment
timeFrame: 14 days
Other outcomes:
Locations:
city: Yogyakarta
country: Indonesia
facility: Central Public Hospital Dr. Sardjito
city: Yogyakarta
country: Indonesia
facility: RSUD Wonosari
city: Yogyakarta
country: Indonesia
facility: RSUP Sleman
city: Yogyakarta
country: Indonesia
facility: Teaching Hospital of Universitas Gadjah Mada (UGM)
Study officials:
affiliation: Gadjah Mada University
name: Ika Trisnawati, MD, MSc, internist
role: PRINCIPAL_INVESTIGATOR
References: