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临床试验/NCT04445441
NCT04445441已完成不适用

An Observational Study to Assess the Effectiveness of the Standard of Care (Hydroxychloroquine+Azythromicin or Chloroquine+Azythromicin) Recommended by the Ministry of Health for the Treatment of the Coronavirus Infection in Burkina Faso

Centre Muraz2 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2020年4月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Centre Muraz
入组人数
153
试验地点
2
主要终点
Clearance of viral load

研究概览

简要总结

This is an observational study to evaluate the effectiveness of the combinations Hydroxychloroquine + Azithromycin (HCQ-AZ) and Chloroquine + Azithromycin (CQ-AZ) in the treatment of Coronavirus (Covid-19) infection in Burkina Faso.

详细描述

All patients who received one of the two combinations will be included in the study and followed-up until the patient is discharged from the hospital. They will be seen daily during the period of their active clinical follow-up at the hospital. At each visit, the medical history since the last visit (including treatments taken), signs and symptoms in progress if any, will be collected. A nasopharyngeal swab will be collected on Day 0, 3, 7 and 14 and then on day 21 if he is still positive in order to assess the evolution of the viral load. However if until the end of the follow-up on D21 the test is still positive, the sampling will be continued until the patient become negative as recommended by the national standard of care for the Covid patients management in Burkina Faso.

In terms of safety, an ECG will be performed on day 0 prior to the treatment administration and this will be repeated on day 7 and day 14 and every week until it normalizes or the patient will be recommended to see a cardiologist to check the normalization of his ECG after discharge from hospital. Adverse events will be recorded including biological parameters (biochemistry and hematology) will be monitored, as well as changes in relevant laboratory parameters.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any patient over 18 years treated according to the standard of care
  • Willing to participate in the study by giving an informed consent

排除标准

  • Patients under 18 years of age
  • Not willing to participate in the study

结局指标

主要结局

Clearance of viral load

时间窗: 14 days

The impact of the treatment on virological clearance (viral load) post-treatment

次要结局

  • Safety of the treatment(14 days)

研究者

发起方
Centre Muraz
申办方类型
Other
责任方
Sponsor

研究点 (2)

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