Evaluation of Sofosbuvir and Daclatasvir Combo in COIVD-19 Patients in Egypt (Single Center Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- evaluate the combined effect of Sofosbuvir and Daclatasvir in treatment of patients with mild-moderate Covid-19.
研究概览
简要总结
Sofosbuvir has been recently recommended as a possible antiviral for COVID-19, based on structural studies and multiple alignment analysis. By comparing the positive-stranded RNA genomes of HCV and SARS-CoV-2, it has been postulated that sofosbuvir might be an optimal nucleotide analogue to repurpose for COVID-19 treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mild- moderate COVID-19 confirmed by PCR
排除标准
- •Patients on renal dialysis
- •Severe COVID-19 cases
- •Patients on amiodarone therapy (given the reported FDA warning of an interaction between amiodarone and sofosbuvir that might lead to severe bradycardia).
- •Children < 12 years
- •Pregnant and breast feeding women
- •Exacerbation of hepatitis B
研究组 & 干预措施
Sofosbuvir / Daclatsvir
A drug used in the treatment of HCV infection, given in the same dose 400mg and 60 mg respectively once daily for 14 days
干预措施: Sofosbuvir 400 MG/ Daclatasvir 60mg (Drug)
结局指标
主要结局
evaluate the combined effect of Sofosbuvir and Daclatasvir in treatment of patients with mild-moderate Covid-19.
时间窗: it is estimated to be 2 weeks
The study assesses the incidence of resolution of symptoms in COVID patients after taking Sofosbuvir and Daclatasvir for 14 days by doing PCR and the result to be negative
次要结局
未报告次要终点
研究者
Amr Aly Abd Elmoety
Professor, Internal Medicine Department
Alexandria University