We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE October 5, 2020
First Posted Date  ICMJE October 20, 2020
Last Update Posted Date October 20, 2020
Actual Study Start Date  ICMJE June 1, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2020)
  • 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)
  • 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
  • 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)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2020)
  • Laboratory outcome of leucocyte count [ Time Frame: 14 days ]
    leucocyte count, measured in 1000/micro liter
  • Laboratory outcome of lymphocyte count [ Time Frame: 14 days ]
    lymphocyte count, measured in percentage
  • Laboratory outcome of neutrophil count [ Time Frame: 14 days ]
    Neutrophil count, measured in percentage
  • Laboratory outcome of neutrophil to lymphocyte ratio, in scale [ Time Frame: 14 days ]
    neutrophil to lymphocyte ratio, in scale
  • Laboratory outcome of D-dimer [ Time Frame: 14 days ]
    D-dimer measured in microgram/Liter
  • Laboratory outcome of TNF-alpha [ Time Frame: 14 days ]
    TNF-alpha, measured in pg/ml
  • Laboratory outcome of CRP value [ Time Frame: 14 days ]
    CRP value measured in qualitative value
  • Laboratory outcome of IL-6 [ Time Frame: 14 days ]
    IL-6 value measured in pg/ml
  • Laboratory outcome of ferritin [ Time Frame: 14 days ]
    Ferritin value measured in mcg/liter
  • Laboratory outcome of procalcitonin [ Time Frame: 14 days ]
    procalcitonin in microgram/liter
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Virgin Coconut Oil (VCO) as a Potential Adjuvant Therapy in COVID-19 Patients
Official Title  ICMJE Pilot Trial for the Benefit of Virgin Coconut Oil (VCO) as a Potential Adjuvant Therapy in COVID-19 Patients
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Coronavirus Infections
Intervention  ICMJE
  • Drug: virgin coconut oil (VCO)
    15 mL of VCO twice a day for 14 days
    Other Name: virgin coconut oil
  • Other: placebo
    15 mL of placebo twice a day for 14 days
    Other Name: mineral water
Study Arms  ICMJE
  • 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)
    Intervention: Drug: virgin coconut oil (VCO)
  • 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
    Intervention: Other: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 19, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04594330
Other Study ID Numbers  ICMJE 002/05/2020
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Ika Trisnawati, Gadjah Mada University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Gadjah Mada University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ika Trisnawati, MD, MSc, internist Gadjah Mada University
PRS Account Gadjah Mada University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP