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

Phase 2

• Conditions: Coronavirus Infections
• Interventions: Drug: virgin coconut oil (VCO); Other: placebo

• Registration Number: NCT04594330
• Lead Sponsor: Gadjah Mada University

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.

Study Timeline

• Study Start: 2020-06-01
• Status Verified: 2020-10
• Study First Submitted: 2020-10-05
• Study First Submitted QC: 2020-10-19
• Last Update Submitted: 2020-10-19
• Study First Posted: 2020-10-20
• Last Update Posted: 2020-10-20
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 - 30 COVID-19 patients aged ≥ 18 years old receiving the investigational drug	virgin coconut oil (VCO)	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	Group 2 - 30 COVID-19 patients receiving standard therapy and placebo

Primary Outcome Measures

Name	Time	Method
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.
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)

Secondary Outcome Measures

Name	Time	Method
Laboratory outcome of TNF-alpha	14 days	TNF-alpha, measured in pg/ml
Laboratory outcome of CRP value	14 days	CRP value measured in qualitative value
Laboratory outcome of D-dimer	14 days	D-dimer measured in microgram/Liter
Laboratory outcome of IL-6	14 days	IL-6 value measured in pg/ml
Laboratory outcome of procalcitonin	14 days	procalcitonin in microgram/liter
Laboratory outcome of leucocyte count	14 days	leucocyte count, measured in 1000/micro liter
Laboratory outcome of neutrophil to lymphocyte ratio, in scale	14 days	neutrophil to lymphocyte ratio, in scale
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 lymphocyte count	14 days	lymphocyte count, measured in percentage
Laboratory outcome of neutrophil count	14 days	Neutrophil count, measured in percentage
Laboratory outcome of ferritin	14 days	Ferritin value measured in mcg/liter

Trial Locations

Locations (4)

RSUD Wonosari; 🇮🇩 Yogyakarta, Indonesia

RSUP Sleman; 🇮🇩 Yogyakarta, Indonesia

Teaching Hospital of Universitas Gadjah Mada (UGM); 🇮🇩 Yogyakarta, Indonesia

Central Public Hospital Dr. Sardjito; 🇮🇩 Yogyakarta, Indonesia