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

Coronavirus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04594330
• Other study ID #: 002/05/2020
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2020
• Source: Gadjah Mada University
• Contact: Ika Trisnawati, MD, MSc, internist
• Phone: 6281228282801
• Email: ika.trisnawati[@]ugm.ac.id
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infections
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• virgin coconut oil (VCO)
15 mL of VCO twice a day for 14 days

Other:
• placebo
15 mL of placebo twice a day for 14 days

Locations

Country	Name	City	State
Indonesia	Central Public Hospital Dr. Sardjito	Yogyakarta
Indonesia	RSUD Wonosari	Yogyakarta
Indonesia	RSUP Sleman	Yogyakarta
Indonesia	Teaching Hospital of Universitas Gadjah Mada (UGM)	Yogyakarta

Sponsors (1)

Lead Sponsor	Collaborator
Gadjah Mada University

Country where clinical trial is conducted

Indonesia, 

Outcome

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