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

• ClinicalTrials.gov Identifier: NCT04594330
• Recruitment Status: Unknown
• First Posted: October 20, 2020
• Last Update Posted: October 20, 2020
• Sponsor: Gadjah Mada University
• Information provided by (Responsible Party): Ika Trisnawati, Gadjah Mada University

Tracking Information

• First Submitted Date: October 5, 2020
• First Posted Date: October 20, 2020
• Last Update Posted Date: October 20, 2020
• Actual Study Start Date: June 1, 2020
• Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 2

Study Design

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: Coronavirus Infections

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 19, 2020): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2020
• Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Indonesia

Administrative Information

• NCT Number: NCT04594330
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Ika Trisnawati, Gadjah Mada University
• Original Responsible Party: Same as current
• Current Study Sponsor: Gadjah Mada University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ika Trisnawati, MD, MSc, internist; Gadjah Mada University

• PRS Account: Gadjah Mada University
• Verification Date: October 2020