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临床试验/IRCT20200318046812N1
IRCT20200318046812N1已完成3 期

Evaluation of safety and efficacy of hydroxychloroquine plus favipiravir drug regimen in comparison with hydroxychloroquine plus kaletra on the need for intensive care unit treatment in patients with COVID-19; a randomized, multicenter, parallel groups, open label study

Iran University of Medical Sciences0 个研究点目标入组 324 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
已完成
入组人数
324

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
16 years 至 100 years(—)
性别
All

入选标准

  • Diagnosis of COVID-19 based on either ground glass appearance in chest CT scan or positive RT-PCR test for COVID-19
  • Requiring hospitalization because of: Patient's oxygen saturation less than 93% OR
  • Requiring hospitalization because of: GCS score less than 15 OR
  • Requiring hospitalization because of: systolic blood pressure less than 100 or 30 mmHg decrease in systolic blood pressure from the level prior to current illness OR
  • Requiring hospitalization because of: renal failure (creatinine 1.5 times the previous measurement in the last 7 days OR
  • Requiring hospitalization because of: liver failure (AST and ALT 3 times upper limit of normal)
  • Patient's age between 16 and 100 years
  • Signed informed consent form.

排除标准

  • Receiving other antiviral medications such as (Kaletra, Ribavirin, Oseltamivir, ...)
  • Chronic liver failure
  • Chronic Renal Failure
  • Patients with acute problems whose survival is expected to be less than 48 hours
  • HIV patients
  • A history of gastrointestinal bleeding
  • Pregnancy and lactation
  • QT interval exceeds 500 ms

研究者

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