Timing of Corticosteroids in COVID-19, II. Post COVID-19 Follow-up
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 752
- 试验地点
- 1
- 主要终点
- Percentage of cases that will need oxygen supplementation
研究概览
简要总结
Timing of of corticosteroids administration is very important in COVID19 cases for the recovery and decrease the mortality.
详细描述
The sickest patients with COVID-19 suffer a hyperinflammatory state-a cytokine storm-that has features in common with a rare haematological condition called haemophagocytic lymphohistiocytosis. Immune suppression should help such patients. By contrast, immune suppression during the early phase of the viral infection might allow increased viral replication and aggravate the disease.
The 3C-like proteinase on SARS-CoV-2 (nsp5) inhibits HDAC2 transport into the nucleus, and so impairs the way in which it mediates inflammation and cytokine responses, so activation of histone deacetylase by dexamethasone may directly oppose the action of SARS-CoV-2.
Timing of of corticosteroids administration is very important in COVID19 cases for the recovery and decrease the mortality.
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
- 否
入选标准
- •any case with COVID-19 more than or equal to 18 years
- •mild and moderate severity
排除标准
- •Severe to critical COVID-19
- •Any contra-indication for the interventional drug
- •Mentally disabled cases
研究组 & 干预措施
Early CS
early use of dexamethasone as early as the laboratory confirmation of inflammation.
干预措施: Early-Corticosteroids (Drug)
结局指标
主要结局
Percentage of cases that will need oxygen supplementation
时间窗: 10 days
Percentage of cases whose clinical status deteriorate that their sPO2 become less than 92%
Percentage of cases that will need hospitalization
时间窗: 10 days
Deterioration in the clinical picture of cases that necessitate hospitalization
28-days mortality
时间窗: 28 days
Percentage of cases who died within 28 days of presentation
次要结局
- Percentage of cases with increased d-dimer(10 days)
- Percentages of COVID-19 Severity according to CDC 2020(10 days)
- Time to return to daily activity(60 days)
- Percentage reduction in LDH(10 days)
- Percentage reduction in CRP(10 days)
- Percentage reduction in Ferritin(10 days)
研究者
Emad R Issak
Dr
ClinAmygate