The Clinical Trial of Application of Ezrin Peptide (HEP-1) for Treatment of Coronavirus Disease (COVID-19) Infection
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Time to clinical improvement of disease symptoms
研究概览
简要总结
Currently, SARS-CoV-2 the novel member of the corona virus family, affecting the world leading to COVID-19 disease. It can result life-threatening condition by developing severe acute respiratory distress syndrome (ARDS). Based on previous evidence a group of patients with severe COVID-19 develop a cytokine storm syndrome which leads to hyper-inflammation lung tissue damage. Supportive care is the current management of COVID-19 is and management of ARDS as a main cause of mortality has been remained challenging. Therefore, an urgent effective treatment of COVID-19 regarding hyper-inflammation mechanism is required. Currently, development of novel anti-viral agents and vaccines are the main issues. However, it needs long time, from months to years, until suitable new medications and vaccines have been developed. An immune-modulatory tetra deca peptide (14-mer peptide) named Human Ezrin Peptide 1 (HEP-1) (trade name Gepon) was introduced by the group of Ataullakhanov in Russia. Regarding its proved anti-viral and anti-inflammatory effect, Russian authorities approved Gepon for treatment of ulcerative colitis treatment and Hepatitis -C.
In this regard, it seems that Hep-1 is a very safe immune-modulatory agent which can be effective in the management of COVID-19 infection without any adverse effect for the patient.
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)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients hospitalized with a positive SARS-CoV-2 PCR test and presenting with one or more clear clinical symptoms of COVID-19 disease
- •No contraindication to HEP-1
- •Obtained informed consent
排除标准
- •Patients who had received any immuno-modulator therapy
- •Active or chronic kidney/ liver diseases,
- •Oncological diseases
- •Other viral infection including HIV and hepatitis.
- •Any allergic reaction or sensitivity to HEP-1
- •Breast feeding or pregnancy
研究组 & 干预措施
No intervention:control group
干预措施: Placebo (Drug)
Experimental:Intervention group
干预措施: Human Ezrin Peptide 1 (HEP1) (Drug)
结局指标
主要结局
Time to clinical improvement of disease symptoms
时间窗: 7 days
Duration of Hospitalization
时间窗: 28 days
Duration of artificial ventilation
时间窗: 28 days
次要结局
- IL-6(28 days)
- CT Severity score(28 days)
- TNF(28 days)
- CRP(28 days)
- IL-1(28 days)
- CBC(28 days)