The Use of the Standardized Brazilian Green Propolis Extract (EPP-AF) as an Adjunct Treatment for Hospitalized COVID-19 Patients: A Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Length of hospital stay
研究概览
简要总结
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) promotes challenging immune and inflammatory phenomena. Though various therapeutic possibilities have been tested against coronavirus disease 2019 (COVID-19), the most adequate treatment has not yet been established. Among candidate adjunct treatment options, propolis, produced by honey bees from bioactive plant exudates, has shown potential against viral targets and has demonstrated immunoregulatory properties.
详细描述
To evaluate the efficacy and safety of oral propolis as an adjunct treatment for SARS-CoV-2 infection, we designed a randomized, double-blind, placebo-controlled trial (Bee-Covid2) (The Use of Brazilian Green Propolis Extract (EPP-AF®) in Patients Affected by COVID-19).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The capsules will be coated, in opaque and equal packaging, so that the researchers involved in the care of patients could not distinguish between propolis and placebo. Neither the participants, nor the principal investigator, nor the health professionals involved in the care will know which group the patients will be allocated.
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
- •Older than 18 years;
- •Diagnosis of coronavirus infection confirmed by polymerase chain reaction - reverse transcriptase testing;
- •Symptoms started within 14 days of the randomization date
排除标准
- •Pregnant or lactating women;
- •Known hypersensitivity to propolis;
- •Propolis use less than 30 days from the randomization date;
- •Active cancer;
- •Human immunodeficiency virus carriers;
- •Patients undergoing transplantation of solid organs or bone marrow or who were using immunosuppressive medications;
- •Bacterial infection at randomization, sepsis or septic shock related to bacterial infection at randomization;
- •Impossibility of using the medication orally or by nasoenteral tube;
- •Known hepatic failure or advanced heart failure (New York Heart Association [NYHA] class III or IV).
- •End Stage Renal Disease (ESRD).
研究组 & 干预措施
Placebo
Patients in the Placebo group will receive an identical number of capsules containing 900 mg / day of placebo (3 capsules of 100 mg each, divided into 3 daily doses); for 10 days.
干预措施: Placebo (Drug)
Propolis
Participants in the Propolis group will receive propolis EPP-AF at a dose of 900 mg / day (3 capsules of 100 mg each, divided into 3 daily doses); for 10 days.
干预措施: Standardized Brazilian Green Propolis Extract (Drug)
结局指标
主要结局
Length of hospital stay
时间窗: 1-28 days
Hospitalization time after randomization (in days)
次要结局
- Percentage of participants with adverse events during the use of propolis or placebo(1-28 days)
- Rate and severity of acute kidney injury during the study(1-28 days)
- Renal replacement therapy.(1-28 days)
- Invasive oxygenation time(1-28 days)
- Need for Intra-Aortic Balloon Pump(1-28 days)
- Rate of need for vasopressor use.(1-28 days)
- Intensive care unit (ICU) readmission(1-28 days)
- Need for Extracorporeal Oxygenation Membrane (ECMO)(1-28 days)
研究者
Marcelo Augusto Duarte Silveira, MD, PhD
Principal Investigator
D'Or Institute for Research and Education