Assessment of the Clinical Effectiveness of Standardized Olive Leaf Capsules; as a Co-therapy in the Treatment of Non-hospitalized COVID-19 Patients; a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Viral clearance in mild to moderate COVID -19 patients
研究概览
简要总结
Starting from December 2019, novel coronavirus disease 2019 (COVID-19) pandemic has caused a tremendous economic loss and unprecedented health crisis across the globe. Discovering an effective and safe drug candidates for the treatment of COVID-19 and its associated symptoms became a global urgent demand especially due to limited data that have been released regarding the vaccine efficacy and safety in humans. Reviewing the recent research, Olive leaf was selected as a potential co-therapy supplement for the treatment and the improvement of clinical manifestations in COVID-19 patients. Olive leaves reported to be rich in phenolic compounds such as oleuropein, hydroxy tyrosol, verbascoside, apigenin-7-glucoside and luteolin-7-glucoside which has been reported as anti-SARS-CoV-2 metabolites in recent In silico, computational and in vitro studies. In addition, olive leaf extract was previously reported in several in vivo studies for its anti-inflammatory, analgesic, antipyretic, immunomodulatory and anti-thrombotic activities which is of a great benefit in the control of associated inflammatory cytokine storm and disseminated intravascular coagulation in COVID-19 patients.
A placebo-controlled, randomized clinical trial at Fayoum University Hospital in Egypt will be conducted. RT-PCR confirmed COVID-19 adults showing mild to moderate disease will be enrolled in the study. Patients presenting with multi-organ failure, ventilator support, and chronic diseases (except diabetes mellitus and hypertension) were excluded. Patients were randomly assigned in 1:1 ratio to receive standardized olive leaves capsules (containing 20-50% oleuropein) or placebo up-to 10 days along with standard care. The expected outcomes included symptom alleviation, viral clearance, improvement of analysis (CBC, CRP, LDH, ESR, Ferritin, D-dimer, creatinine, ALT and AST) and a 10-day mortality in intention-to-treat population.
详细描述
Objectives:
We will evaluate the efficacy of standardized olive leaf capsules as additive therapy to the standard therapeutic regimen (for a period 10 days) on clinical symptoms, viral clearance, improvement of analysis:
- Complete blood count (CBC).
- C-Reactive Protein (CRP)
- Lactate dehydrogenase (LDH).
- Erythrocyte Sedimentation rate (ESR).
- Serum Ferritin
- D-dimer
- Serum creatinine.
- Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST).
- Also, a 30-day mortality in patients with confirmed COVID-19, who are mild to moderately ill.
Trial design:
This is a single-center, randomized, double-blind, placebo-controlled clinical trial with a parallel-group design conducted at Fayoum university Hospital, Fayoum, Egypt.
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)
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
- •Confirmed SARS-CoV-2 diagnosis (positive polymerase chain reaction by nasopharyngeal swab).
- •Mild to Moderate COVID-19 patients.
- •No history of the current use of olive leaf capsules supplement.
排除标准
- •Severe and critical COVID-19 patients who need hospitalization.
- •Patients need ventilatory support or showing chronic obstructive pulmonary disease (COPD).
- •Patients showing any chronic disease (except hypertension and diabetes mellitus).
- •Patients who have multiorgan failure.
- •Use of alcohol, other investigational medicines, and illegal drugs (during the last 30 days).
结局指标
主要结局
Viral clearance in mild to moderate COVID -19 patients
时间窗: 10 days after treatment
It is expected that the examined drug will make the Polymerase chain reaction (PCR ) results for the test group negative within 10 days of treatment
Improving the clinical symptoms in mild to moderate COVID -19 patients
时间窗: 10 days after treatment
It is expected that the examined drug will alleviate symptoms such as fever, cough, sore throat and muscles ache
Improvement of analysis (CRP)
时间窗: 10 days after treatment
It is expected that the treatment will improve the lab analysis for treatment group and prevent elevation and/or decrease the elevated values of C-reactive protein (CRP).
Improvement of analysis (LDH)
时间窗: 10 days after treatment
It is expected that the treatment will improve the lab analysis for treatment group and prevent elevation and/or decrease the elevated values of Lactate dehydrogenase (LDH).
Improvement of analysis (ESR)
时间窗: 10 days after treatment
It is expected that the treatment will improve the lab analysis for treatment group and prevent elevation and/or decrease the elevated values of Erythrocyte sedimentation rate (ESR).
Improvement of analysis (D-dimer)
时间窗: 10 days after treatment
It is expected that the treatment will improve the lab analysis for treatment group and prevent elevation and/or decrease the elevated values of D-dimer.
Improvement of analysis (CBC)
时间窗: 10 days after treatment
It is expected that the treatment will improve the lab analysis for treatment group such as increase lymphocyte count in complete blood count (CBC).
Improvement of analysis (Ferritin)
时间窗: 10 days after treatment
It is expected that the treatment will improve the lab analysis for treatment group and prevent elevation and/or decrease the elevated values of Ferritin.
次要结局
- Evaluate mortality rate in patients with confirmed COVID-19 moderately ill(10 days after treatment)
- Improvement of analysis (creatinine)(10 days after treatment)
- Improvement of analysis (ALT)(10 days after treatment)
- improvement of analysis (AST)(10 days after treatment)
研究者
Shimaa M. Abdelgawad
Assisting lecturer, Pharmacognosy Department, Faculty of Pharmacy, Fayoum University, Egypt
Fayoum University