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临床试验/NCT04528329
NCT04528329招募中4 期

Anosmia and / or Ageusia in COVID-19: Timeline, Treatment With Early Corticosteroid and Recovery

ClinAmygate1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年3月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
Time to recovery

研究概览

简要总结

Time to recover of Anosmia and / or ageusia and early corticosteroid use

详细描述

In a study of dexamethasone kinetics in two groups of 15 patients with community-acquired pneumonia, one group was treated with dexamethasone 6 mg/day by mouth and the other with 4 mg/day intravenously. The apparent volume of distribution was 1 L/kg in both groups, but the half-life after oral administration was approximately 7 hours, and after intravenous administration 9 hours. The bioavailability of oral dexamethasone was 81% (95% CI = 54-121%). However, the biological half-life of dexamethasone is much longer, of the order of 36-54 h compared with 18-36 h for prednisolone.

Time to recover of Anosmia and / or ageusia and early corticosteroid use

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
None

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

  • Any case with COVID-19
  • Age more than or equal to 18 years
  • Mild to moderate severity

排除标准

  • Any contra-indication for the interventional drug
  • Mentally disabled cases

研究组 & 干预措施

Early CS

Experimental

early use of dexamethasone as early as the laboratory confirmation of inflammation.

干预措施: Early-Dexamethasone (Drug)

Late CS

Active Comparator

Dexamethasone is to be used lately upon the deterioration of cases

干预措施: Late dexamethazone (Drug)

结局指标

主要结局

Time to recovery

时间窗: one to 6 weeks

Time to recovery from anosmia and / or agusia

次要结局

未报告次要终点

研究者

发起方
ClinAmygate
申办方类型
Other
责任方
Sponsor

研究点 (1)

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