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

Gadjah Mada University

Status and phase: Unknown; Phase 2

Conditions: Coronavirus Infections

Treatments: Drug: virgin coconut oil (VCO); Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04594330

002/05/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Group 1 - 30 COVID-19 patients aged ≥ 18 years old receiving the investigational drug

Active Comparator group

Description:

Group 1 - 30 COVID-19 patients receiving standard therapy and the investigational drug (Virgin Coconut Oil)

Treatment:

Drug: virgin coconut oil (VCO)

Group 2 - 30 COVID-19 patients aged ≥ 18 years old receiving placebo

Placebo Comparator group

Description:

Group 2 - 30 COVID-19 patients receiving standard therapy and placebo

Treatment:

Other: placebo