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临床试验/NCT04622891
NCT04622891已完成不适用

Efficacy of Clarithromycin in Comparison to Azithromycin in Treatment of Mild COVID-19 Infection, Randomized Controlled Trial

South Valley University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
time to fever control

研究概览

简要总结

The current study was conducted at Qena Governorate, Egypt, during the period from May 2020, to July 2020. The study included 305 COVID-19 cases diagnosed by PCR, patients were randomly assigned to one of three study limps, Azithromycin 500 mg/24 h for 7 days, Clarithromycin 500 /12 h for 7 days, or a control group with no antibiotics, All three groups received only symptomatic treatment for control of fever and cough

详细描述

The current study was conducted at Qena Governorate, Egypt, during the period from May 2020, to July 2020. The study included 305 COVID-19 cases diagnosed by PCR, patients were randomly assigned to one of three study limps, Azithromycin 500 mg/24 h for 7 days, Clarithromycin 500 /12 h for 7 days, or a control group with no antibiotics, All three groups received only symptomatic treatment for control of fever and cough.

All study participants underwent full clinical evaluation including duration of fever, cough, dyspnea, anosmia or GIT symptoms, C-reactive protein (CRP), serum ferritin, D-dimer, Complete blood count (CBC), non-contrast chest computed tomography (CT) which was repeated 2 weeks after the start of treatment.

The Azithromycin group included, 107 patients, mean age 45.8 ±18 years, 73 male and 34 female, the Clarithromycin group included 99 patients mean age 46.1±19 years, 68 males and 31 female, the control group included 99 patients, with mean age 41.1 ± 18 years, 73 male and 28 female.

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, Outcomes Assessor)

盲法说明

double-blinded

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COVID-19 cases
  • Oxygen saturation > 93%
  • Age >18 years

排除标准

  • Patients <18 years,
  • patients with Oxygen saturation < 93%, patients with
  • Diabetes mellitus or
  • heart failure,
  • patients on chemotherapy or immunosuppressive therapy

研究组 & 干预措施

clarithromycin

Experimental

clarithromycin group

干预措施: Clarithromycin 500mg (Drug)

Azithromycin

Active Comparator

azithromycin group

干预措施: Azithromycin (Drug)

control

Placebo Comparator

control group

干预措施: Placebo (Drug)

结局指标

主要结局

time to fever control

时间窗: 15 days

time to complete resolution of fever

次要结局

  • PCR conversion(15 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaa Rashad

Associate professor of chest diseases

South Valley University

研究点 (1)

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