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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronavirus Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

The participants and care provider are blinded to the type of treatment that the participants receive.

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

virgin coconut oil (VCO)

Intervention Type DRUG

15 mL of VCO twice a day for 14 days

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

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

15 mL of placebo twice a day for 14 days

Interventions

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virgin coconut oil (VCO)

15 mL of VCO twice a day for 14 days

Intervention Type DRUG

placebo

15 mL of placebo twice a day for 14 days

Intervention Type OTHER

Other Intervention Names

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virgin coconut oil mineral water

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No