Non-interventional, Retrospective, Multicenter, Follow-up Study Evaluating the Effect of C21 on Lung Pathology in Subjects Previously Hospitalized With COVID-19 and Enrolled in the VP-C21-006 Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 4
- 主要终点
- Averaged total lung score for both lungs percent measured by per lung percent scores
研究概览
简要总结
Non-interventional, retrospective, multi-center, follow-up study evaluating the effect of C21 on lung pathology in subjects previously hospitalised with COVID-19 and enrolled in the VP-C21-006 trial.
详细描述
The study will collect available HRCT scans obtained prior to, during treatment with C21 or placebo and up to 24 weeks after trial completion.
HRCT scans will be assessed for ground glass opacity, reticulation, band opacity, fibrosis and consolidation by a central, blinded HRCT reader.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Previously included in the VP-C21-006 trial and received at least one dose of investigational medicinal product (IMP)
- •Available record of at least one HRCT performed within 24 weeks after completion of VP-C21-006.
排除标准
- •Participation in another interventional trial during the historical period covered by this study that could interfere with the study objectives or evaluation
研究组 & 干预措施
C21
Participants treated with C21 in the VP-C21-006 trial
干预措施: C21 (Drug)
Placebo
Participants treated with placebo in the VP-C21-006 trial
干预措施: Placebo (Drug)
结局指标
主要结局
Averaged total lung score for both lungs percent measured by per lung percent scores
时间窗: Up to 24 weeks after completion of VP-C21-006
Based on ground glass opacity, reticulation, band opacity, fibrosis, and consolidation, on HRCT
Change from baseline in percent lung involvement measured totally (averaged total lung score for both lungs percent) and by each of ground glass opacity, reticulation, band opacity, fibrosis, and consolidation on follow-up HRCT
时间窗: Up to 24 weeks after completion of VP-C21-006
次要结局
未报告次要终点