Pilot Trial for the Benefit of Virgin Coconut Oil (VCO) as a Potential Adjuvant Therapy in COVID-19 Patients
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Allergic reaction severity in mild, moderate, or severe
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
The participants and care provider are blinded to the type of treatment that the participants receive.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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)
干预措施: virgin coconut oil (VCO) (Drug)
Group 2 - 30 COVID-19 patients aged ≥ 18 years old receiving placebo
Group 2 - 30 COVID-19 patients receiving standard therapy and placebo
干预措施: placebo (Other)
结局指标
主要结局
Allergic reaction severity in mild, moderate, or severe
时间窗: 14 days
Probable side effects of the virgin coconut oil, i.e. allergic reaction severity, categorized in mild, moderate, or severe reaction.
Ordinal scale for measuring clinical improvement by the World Health Organization (WHO)
时间窗: 14 days
Clinical improvement determined by the World Health Organization (WHO) in ordinal scale (0-8)
Clinical symptoms improvement, determined with interview and examination
时间窗: 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
时间窗: 14 days
Probable side effects of the virgin coconut oil, i.e. headache, stomachache, muscle pain, measured in Visual Analog Scale (0-10)
次要结局
- Laboratory outcome of TNF-alpha(14 days)
- Laboratory outcome of CRP value(14 days)
- Laboratory outcome of D-dimer(14 days)
- Laboratory outcome of IL-6(14 days)
- Laboratory outcome of procalcitonin(14 days)
- Laboratory outcome of leucocyte count(14 days)
- Laboratory outcome of neutrophil to lymphocyte ratio, in scale(14 days)
- chest radiology outcome, measured as improvement of infiltrate based on expert assessment(14 days)
- Laboratory outcome of lymphocyte count(14 days)
- Laboratory outcome of neutrophil count(14 days)
- Laboratory outcome of ferritin(14 days)
研究者
Ika Trisnawati
dr., MSc., internist-pulmonologist
Gadjah Mada University