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临床试验/NCT05642923
NCT05642923已完成4 期

Post-COVID-19 Chronic Fatigue Syndrome

ClinAmygate1 个研究点 分布在 1 个国家目标入组 528 人开始时间: 2023年1月8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
已完成
发起方
入组人数
528
试验地点
1
主要终点
Fatigue scale

研究概览

简要总结

Fatigue is recognized as one of the most commonly presented long-term complaints in individuals previously infected with SARS-CoV-2.

详细描述

It has become increasingly clear that infected patients have symptoms not only in the acute phase, but also after recovery from the initial infection.

A recent meta-analysis including 4828 patients with post-COVID-19 showed that symptoms and post-acute sequelae of SARS-CoV-2 can persist weeks to months after the infection.

These patients who reported persistent symptoms have been termed "long haulers" or described as having long COVID, post-acute COVID-19, persistent COVID-19 symptoms, post COVID-19 manifestations, long-term COVID-19 effects, post-acute sequelae of COVID-19 (PASC), or post-COVID-19 syndrome.

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
Single (Outcomes Assessor)

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

  • Male or female
  • Post-Covid-19 Fatigue

排除标准

  • 未提供

研究组 & 干预措施

Synthetic Vitamin B1

Active Comparator

Synthetic Vitamin B1, 400 mg per day

干预措施: Synthetic Vitamin B1 (Drug)

结局指标

主要结局

Fatigue scale

时间窗: three month

chalder fatigue scale: the minimum = 0 and maximum values = 33, and whether higher scores mean a worse outcome.

次要结局

  • Incidence of adverse events(6 months)

研究者

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

Emad R Issak

Dr

ClinAmygate

研究点 (1)

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