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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04594330
Recruitment Status : Unknown
Verified October 2020 by Ika Trisnawati, Gadjah Mada University.
Recruitment status was:  Recruiting
First Posted : October 20, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Ika Trisnawati, Gadjah Mada University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronavirus Infections Drug: virgin coconut oil (VCO) Other: placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Participant, Care Provider)
Masking Description: The participants and care provider are blinded to the type of treatment that the participants receive.
Primary Purpose: Treatment
Official Title: Pilot Trial for the Benefit of Virgin Coconut Oil (VCO) as a Potential Adjuvant Therapy in COVID-19 Patients
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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)
 Drug: virgin coconut oil (VCO)
15 mL of VCO twice a day for 14 days
Other Name: virgin coconut oil
Placebo Comparator: Group 2 - 30 COVID-19 patients aged ≥ 18 years old receiving placebo
Group 2 - 30 COVID-19 patients receiving standard therapy and placebo
 Other: placebo
15 mL of placebo twice a day for 14 days
Other Name: mineral water


Outcome Measures
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Primary Outcome Measures :
  1. Ordinal scale for measuring clinical improvement by the World Health Organization (WHO) [ Time Frame: 14 days ]
    Clinical improvement determined by the World Health Organization (WHO) in ordinal scale (0-8)

  2. Clinical symptoms improvement, determined with interview and examination [ Time Frame: 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

  3. Pain as side effects of the drugs, measured by Visual Analog Scale [ Time Frame: 14 days ]
    Probable side effects of the virgin coconut oil, i.e. headache, stomachache, muscle pain, measured in Visual Analog Scale (0-10)

  4. Allergic reaction severity in mild, moderate, or severe [ Time Frame: 14 days ]
    Probable side effects of the virgin coconut oil, i.e. allergic reaction severity, categorized in mild, moderate, or severe reaction.


Secondary Outcome Measures :
  1. Laboratory outcome of leucocyte count [ Time Frame: 14 days ]
    leucocyte count, measured in 1000/micro liter

  2. Laboratory outcome of lymphocyte count [ Time Frame: 14 days ]
    lymphocyte count, measured in percentage

  3. Laboratory outcome of neutrophil count [ Time Frame: 14 days ]
    Neutrophil count, measured in percentage

  4. Laboratory outcome of neutrophil to lymphocyte ratio, in scale [ Time Frame: 14 days ]
    neutrophil to lymphocyte ratio, in scale

  5. Laboratory outcome of D-dimer [ Time Frame: 14 days ]
    D-dimer measured in microgram/Liter

  6. Laboratory outcome of TNF-alpha [ Time Frame: 14 days ]
    TNF-alpha, measured in pg/ml

  7. Laboratory outcome of CRP value [ Time Frame: 14 days ]
    CRP value measured in qualitative value

  8. Laboratory outcome of IL-6 [ Time Frame: 14 days ]
    IL-6 value measured in pg/ml

  9. Laboratory outcome of ferritin [ Time Frame: 14 days ]
    Ferritin value measured in mcg/liter

  10. Laboratory outcome of procalcitonin [ Time Frame: 14 days ]
    procalcitonin in microgram/liter

  11. chest radiology outcome, measured as improvement of infiltrate based on expert assessment [ Time Frame: 14 days ]
    chest radiology outcome, measured as improvement of infiltrate based on expert assessment in day 1 and 14


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04594330


Contacts
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Contact: Ika Trisnawati, MD, MSc, internist 6281228282801 ika.trisnawati@ugm.ac.id

Locations
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Indonesia
Central Public Hospital Dr. Sardjito Recruiting
Yogyakarta, Indonesia
Contact: Nur R Ananda, MD, internist-pulmonologist         
RSUD Wonosari Recruiting
Yogyakarta, Indonesia
Contact: Paulus Wisnu, MD, pulmonologist         
RSUP Sleman Recruiting
Yogyakarta, Indonesia
Contact: Desy NP, MD         
Teaching Hospital of Universitas Gadjah Mada (UGM) Recruiting
Yogyakarta, Indonesia
Contact: Eko Purnomo, MD, PhD, surgeon         
Sponsors and Collaborators
Gadjah Mada University
Investigators
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Principal Investigator: Ika Trisnawati, MD, MSc, internist Gadjah Mada University
More Information
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Responsible Party: Ika Trisnawati, dr., MSc., internist-pulmonologist, Gadjah Mada University
ClinicalTrials.gov Identifier: NCT04594330    
Other Study ID Numbers: 002/05/2020
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ika Trisnawati, Gadjah Mada University:
COVID-19
treatment
virgin coconut oil
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
 Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases