The Use of Brazilian Green Propolis Extract (EPP-AF) in Patients Affected by COVID-19: a Randomized, Open and Pilot Clinical Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Composite clinical outcome with oxygen therapy dependency time or hospitalization time
研究概览
简要总结
The COVID-19 pandemic is of grave concern due its impact on human health and on the economy. Propolis, a natural resin produced by bees from plant materials, has anti-inflammatory, immunomodulatory, anti-oxidant properties, and various aspects of the SARS-CoV-2 infection mechanism are potential targets for propolis compounds. Propolis components have inhibitory effects on the ACE2, TMPRSS2 and PAK1 signaling pathways; in addition, antiviral activity has been proven in vitro and in vivo. This is a pilot randomized study that aims to assess the impact of using Brazilian green propolis extract against the deleterious effects of the new coronavirus.
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)
盲法说明
The individual who evaluates the results of interest to the study will not have access to the study steps before the analysis.
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
- •Hospitalized patients;
- •Positive RT-PCR for SARS-CoV-2;
- •18 Years and older.
排除标准
- •Pregnant women;
- •People with active cancer;
- •Patients undergoing transplantation of solid organs or bone marrow or who use immunosuppressive medications;
- •HIV carriers;
- •Allergy to propolis or any of its components;
- •Bacterial infection at randomization;
- •Sepsis or septic shock before randomization;
- •Patients unable to use medication orally or via nasoenteral tube;
- •Patients with severe chronic liver disease (Child B or C);
- •Patients with advanced heart failure;
研究组 & 干预措施
Control
standard care.
干预措施: Standard care (Other)
EPP-AF 400mg/day
Green propolis extract (EPP-AF) at a dose of 400mg / day in addition to the standard treatment.
干预措施: Brazilian Green Propolis Extract (EPP-AF) (Drug)
EPP-AF 800mg/day
Green propolis extract (EPP-AF) at a dose of 800mg / day in addition to the standard treatment.
干预措施: Brazilian Green Propolis Extract (EPP-AF) (Drug)
结局指标
主要结局
Composite clinical outcome with oxygen therapy dependency time or hospitalization time
时间窗: 1-28 days
Composite clinical outcome with oxygen therapy dependency time (in days) or hospitalization time (in days) after randomization.
次要结局
- Percentage of participants with adverse events during the use of propolis(1-28 days)
- Rate and severity of acute kidney injury during the study(1-28 days)
- Rate of need for vasopressor use(1-28 days)
- Intensive care unit (ICU) readmission(1-28 days)
- Invasive oxygenation time(1-28 days)
- Variation of plasma c-reactive protein(1-7 days)
- Renal replacement therapy.(1-28 days)
- Need for intensive care unit (ICU)(1-28 days)
研究者
Marcelo Silveira
Principal Investigator
D'Or Institute for Research and Education