A Multi-centre, Multi-country Retrospective Cohort Study to Evaluate the Clinical Outcomes in Adults With Covid-19 Who Have Been Treated With Remdesivir.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 451
- 试验地点
- 12
- 主要终点
- All Case Mortality by Day 28
研究概览
简要总结
This is a multi-centre, multi-country retrospective cohort study. At least 450COVID-19 cases from up to 20 participating study sites who meet all eligibility criteria will be included in the analysis. Deidentified data will be extracted from electronic medical record (EMR) databases, clinical registries, case series or additional sources from participating sites and countries, and then entered into a structured e-CRF system. addition, each site/country will be surveyed to determine the local standard of care therapy for COVID-19 infection and to determine if standard protocols were/are in place for the use of Remdesivir and if/how the protocols changed over time.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All Adult participants with COVID-19 confirmed by PCR who meet the following criteria:
- •Hospitalised after August 31st,2020
- •Receivedat least one dose of Remdesivir(RDV)at anytime during hospitalisation
排除标准
- •Received Remdesivir as part of a clinical trial, compassionate use or expanded access program
- •Received Remdesivir prior to this admission at any other health facility than the research sites and whose health records are available.
研究组 & 干预措施
Target Population
Adults with COVID-19 diagnosed and treated with Remdesivir after Aug 31st2020.
干预措施: Remdesivir (Drug)
结局指标
主要结局
All Case Mortality by Day 28
时间窗: Day 28
Occurrence of death within 28 days.
Duration of Hopitalisation
时间窗: Day 28
Number of hospital discharges by day 28.
次要结局
- Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale(Day 7)
- Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14(Day 14)
- Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score(Day 7, 14, and 28)
- Timing of Remdesivir Exposure(Day 28)
- Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28(Day 28)
- SpO2 > 94% on Room Air(Day 28)
- Duration of Oxygen Therapy(Day 28)
- ICU Admission(Day 28)
- Duration of ICU(through study completion, 28 days)
- Mechanical Ventilation/ECMO Use(Day 28)
- Timing From Hospitalisation to Remdesivir Exposure(Day 28)
- Duration of Remdesivir Use(Day 28)
- Readmission With COVID-19 Complications(Day 28)