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

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronavirus Infections
• Intervention / Treatment: Drug: virgin coconut oil (VCO); Other: placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Indonesia
  • Yogyakarta, Indonesia
    • Recruiting
    • Central Public Hospital Dr. Sardjito
    • Contact: Nur R Ananda, MD, internist-pulmonologist
  • Yogyakarta, Indonesia
    • Recruiting
    • RSUD Wonosari
    • Contact: Paulus Wisnu, MD, pulmonologist
  • Yogyakarta, Indonesia
    • Recruiting
    • RSUP Sleman
    • Contact: Desy NP, MD
  • Yogyakarta, Indonesia
    • Recruiting
    • Teaching Hospital of Universitas Gadjah Mada (UGM)
    • Contact: Eko Purnomo, MD, PhD, surgeon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gadjah Mada University
• Investigators: Principal Investigator: Ika Trisnawati, MD, MSc, internist, Gadjah Mada University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Actual): October 20, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: treatment; COVID-19; virgin coconut oil
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections
• Other Study ID Numbers: 002/05/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No