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

NCT04594330 | Unknown Phase 2

• 1 other identifier: 002/05/2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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.

Conditions

Coronavirus Infections

Keywords

COVID-19; treatment; virgin coconut oil

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (11)

• Laboratory outcome of leucocyte count

  14 days

• Laboratory outcome of lymphocyte count

  14 days

• Laboratory outcome of neutrophil count

  14 days

• Laboratory outcome of neutrophil to lymphocyte ratio, in scale

  14 days

• Laboratory outcome of D-dimer

  14 days

Study Arms (2)

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

ACTIVE COMPARATOR

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

Drug: virgin coconut oil (VCO)

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

PLACEBO COMPARATOR

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

Other: placebo

Interventions

virgin coconut oil (VCO) DRUG

15 mL of VCO twice a day for 14 days

Also known as: virgin coconut oil

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

placebo OTHER

15 mL of placebo twice a day for 14 days

Also known as: mineral water

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gadjah Mada University: lead

Study Sites (4)

Central Public Hospital Dr. Sardjito

Yogyakarta, Indonesia

RECRUITING

RSUD Wonosari

Yogyakarta, Indonesia

RECRUITING

RSUP Sleman

Yogyakarta, Indonesia

RECRUITING

Teaching Hospital of Universitas Gadjah Mada (UGM)

Yogyakarta, Indonesia

RECRUITING

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Interventions

Mineral Waters

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Ika Trisnawati, MD, MSc, internist

  Gadjah Mada University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ika Trisnawati, MD, MSc, internist

CONTACT

6281228282801; ika.trisnawati@ugm.ac.id

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The participants and care provider are blinded to the type of treatment that the participants receive.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr., MSc., internist-pulmonologist

Model Details: 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.

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 20, 2020
• Study Start: June 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: October 20, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

ID (4)