Virgin Coconut Oil as Adjunctive Therapy for Hospitalized COVID-19 Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Duration of hospital stay
研究概览
简要总结
This is a research that will investigate the safety and efficacy of virgin coconut oil (VCO) as an adjunctive therapy for Coronavirus Disease 2019 (COVID-19)
详细描述
This study will be a randomized controlled trial among hospitalized COVID-19 patients, aged 18 years old and above, admitted at the Philippine General hospital. Patients will be grouped into the following:
- Group receiving standard of care
- Group receiving standard of care plus virgin coconut oil (15ml, 3x/day for 2 weeks) as adjunctive therapy.
Patients will be observed as regards to primary outcomes such as recovery/resolution of symptoms and duration of hospital stay
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
- Single (Outcomes Assessor)
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
- •symptomatic and asymptomatic COVID-19 hospitalized patients
- •has laboratory-confirmed illness during the time of recruitment
- •able to take food and medicines enterally
排除标准
- •uncontrolled or newly diagnosed diabetes mellitus
- •with chronic heart disease
- •having elevated lipid profile at baseline (admission)
研究组 & 干预措施
Standard of care plus adjunctive virgin coconut oil supplementation
Standard of care plus virgin coconut oil
干预措施: Virgin Coconut Oil (Drug)
结局指标
主要结局
Duration of hospital stay
时间窗: Two weeks
To determine if the VCO intervention can lessen the duration of stay in the hospital by at least 2 days
Time to recovery/resolution of symptoms
时间窗: Two weeks
Patient will be assessed based on the following secondary outcome: time interval before ventilation, ICU and negative results on PCR swab test
次要结局
- Time to first receipt of ventilation and admission to intensive care unit(Two weeks)
- IL-6 levels (pg/mL)(Two weeks)
- CRP levels (mg/dL)(Two weeks)
- LDH levels (mg/dL0(Two weeks)
- TNF-Alpha levels (pg/mL)(Two weeks)
- Interferon-gamma levels (pg/mL)(Two weeks)
- Monocyte chemoattractant protein levels (pg/mL)(Two weeks)
- Immunoglobulin levels (mg/L)(Two weeks)
- Ferritin levels (ng/mL)(Two weeks)
- CD4+ counts (cells/L)(Two weeks)