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

Primary Purpose

Coronavirus Infections

Status
Unknown status
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
virgin coconut oil (VCO)
placebo
Sponsored by
Gadjah Mada University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus Infections focused on measuring COVID-19, treatment, virgin coconut oil

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Central Public Hospital Dr. SardjitoRecruiting
  • RSUD WonosariRecruiting
  • RSUP SlemanRecruiting
  • Teaching Hospital of Universitas Gadjah Mada (UGM)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

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

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

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)
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
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)
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.

Secondary Outcome Measures

Laboratory outcome of leucocyte count
leucocyte count, measured in 1000/micro liter
Laboratory outcome of lymphocyte count
lymphocyte count, measured in percentage
Laboratory outcome of neutrophil count
Neutrophil count, measured in percentage
Laboratory outcome of neutrophil to lymphocyte ratio, in scale
neutrophil to lymphocyte ratio, in scale
Laboratory outcome of D-dimer
D-dimer measured in microgram/Liter
Laboratory outcome of TNF-alpha
TNF-alpha, measured in pg/ml
Laboratory outcome of CRP value
CRP value measured in qualitative value
Laboratory outcome of IL-6
IL-6 value measured in pg/ml
Laboratory outcome of ferritin
Ferritin value measured in mcg/liter
Laboratory outcome of procalcitonin
procalcitonin in microgram/liter
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

Full Information

First Posted
October 5, 2020
Last Updated
October 19, 2020
Sponsor
Gadjah Mada University
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1. Study Identification

Unique Protocol Identification Number
NCT04594330
Brief Title
Virgin Coconut Oil (VCO) as a Potential Adjuvant Therapy in COVID-19 Patients
Official Title
Pilot Trial for the Benefit of Virgin Coconut Oil (VCO) as a Potential Adjuvant Therapy in COVID-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gadjah Mada University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infections
Keywords
COVID-19, treatment, virgin coconut oil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantCare Provider
Masking Description
The participants and care provider are blinded to the type of treatment that the participants receive.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 - 30 COVID-19 patients aged ≥ 18 years old receiving the investigational drug
Arm Type
Active Comparator
Arm Description
Group 1 - 30 COVID-19 patients receiving standard therapy and the investigational drug (Virgin Coconut Oil)
Arm Title
Group 2 - 30 COVID-19 patients aged ≥ 18 years old receiving placebo
Arm Type
Placebo Comparator
Arm Description
Group 2 - 30 COVID-19 patients receiving standard therapy and placebo
Intervention Type
Drug
Intervention Name(s)
virgin coconut oil (VCO)
Other Intervention Name(s)
virgin coconut oil
Intervention Description
15 mL of VCO twice a day for 14 days
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
mineral water
Intervention Description
15 mL of placebo twice a day for 14 days
Primary Outcome Measure Information:
Title
Ordinal scale for measuring clinical improvement by the World Health Organization (WHO)
Description
Clinical improvement determined by the World Health Organization (WHO) in ordinal scale (0-8)
Time Frame
14 days
Title
Clinical symptoms improvement, determined with interview and examination
Description
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
Time Frame
14 days
Title
Pain as side effects of the drugs, measured by Visual Analog Scale
Description
Probable side effects of the virgin coconut oil, i.e. headache, stomachache, muscle pain, measured in Visual Analog Scale (0-10)
Time Frame
14 days
Title
Allergic reaction severity in mild, moderate, or severe
Description
Probable side effects of the virgin coconut oil, i.e. allergic reaction severity, categorized in mild, moderate, or severe reaction.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Laboratory outcome of leucocyte count
Description
leucocyte count, measured in 1000/micro liter
Time Frame
14 days
Title
Laboratory outcome of lymphocyte count
Description
lymphocyte count, measured in percentage
Time Frame
14 days
Title
Laboratory outcome of neutrophil count
Description
Neutrophil count, measured in percentage
Time Frame
14 days
Title
Laboratory outcome of neutrophil to lymphocyte ratio, in scale
Description
neutrophil to lymphocyte ratio, in scale
Time Frame
14 days
Title
Laboratory outcome of D-dimer
Description
D-dimer measured in microgram/Liter
Time Frame
14 days
Title
Laboratory outcome of TNF-alpha
Description
TNF-alpha, measured in pg/ml
Time Frame
14 days
Title
Laboratory outcome of CRP value
Description
CRP value measured in qualitative value
Time Frame
14 days
Title
Laboratory outcome of IL-6
Description
IL-6 value measured in pg/ml
Time Frame
14 days
Title
Laboratory outcome of ferritin
Description
Ferritin value measured in mcg/liter
Time Frame
14 days
Title
Laboratory outcome of procalcitonin
Description
procalcitonin in microgram/liter
Time Frame
14 days
Title
chest radiology outcome, measured as improvement of infiltrate based on expert assessment
Description
chest radiology outcome, measured as improvement of infiltrate based on expert assessment in day 1 and 14
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ika Trisnawati, MD, MSc, internist
Phone
6281228282801
Email
ika.trisnawati@ugm.ac.id
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ika Trisnawati, MD, MSc, internist
Organizational Affiliation
Gadjah Mada University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Public Hospital Dr. Sardjito
City
Yogyakarta
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nur R Ananda, MD, internist-pulmonologist
Facility Name
RSUD Wonosari
City
Yogyakarta
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paulus Wisnu, MD, pulmonologist
Facility Name
RSUP Sleman
City
Yogyakarta
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Desy NP, MD
Facility Name
Teaching Hospital of Universitas Gadjah Mada (UGM)
City
Yogyakarta
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eko Purnomo, MD, PhD, surgeon

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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