CTRI/2021/05/033742招募中不适用
A Retrospective study of Comparing outcomes of Moderate and severe COVID-19 Pneumonia in patients treated with guideline based remdesivir regimen and non-remdesivir regimen†RESCUER study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- 1. Time to clinical recovery
研究概览
简要总结
Remdesivir is a nucleotide analogue which inhibits viral RNA polymerases, is the best prospect among currently available antivirals against SARS-CoV-2 virus. It is effective in viral replication phase than in immune dysregulation phase of COVID-19 infection. Hence, patients received this drug in the appropriate phase will have benefit.
Results of the study will give inputs to the efficacy and side effects of this drug. Even though the level of Evidence for retrospective study is III, when compare the randomised prospective study, results of this study will have and impact in the future use of this drug Remdesivir in COVID-19 pneumonia.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 13.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Age ≥12 years with Confirmed COVID-
- •(Laboratory (RT-PCR) – Positive) Moderate COVID pneumonia: Moderate Pneumonia (frequent fever, cough) with no obvious hypoxemia, chest CT with lesions.
- •Severe COVID pneumonia: Severe Pneumonia with hypoxemia (SpO2 < 92%).
- •Patients received Remdesivir (Case) and also not received it (Control group).
排除标准
- •Mild infection (without CT lesions) Critical pneumonias (CT involvement > 75%).
- •Patients with moderate and Severe pneumonia but died within 3 days of hospital admission.
- •Patient who received Tocilizumab (critical pts) Severe liver disease (AST > 5 times upper limit) Patients with severe renal impairment (estimated GFR ≤30 mL/min/1.73 m2) or receiving continuous Dialysis Pregnant or breastfeeding mothers.
- •Patient transferred to another hospital within 72 hours.
- •Cases with inadequate datas.
结局指标
主要结局
1. Time to clinical recovery
时间窗: one month
2. All cause mortality
时间窗: one month
次要结局
- 1. Duration of invasive mechanical ventilation(2. Duration of noninvasive ventilation or use of high-flow Nasal oxygen devices (HFNO);)
研究者
研究点 (1)
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