IRCT20171122037571N2招募中2 期
A single-arm multicenter clinical trial to evaluate the safety and efficacy of Remdesivir in COVID-19 patients with progressive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 no limit（—）
- 性别
- All
入选标准
- •Ablility to fully understand, willingness to participate, and signing the informed consent form (in case of decreased level of consciousness or/ and cognitive impairment, informed consent is obtained from their legal representative)
- •Ages over 18 years
- •Patients with a definitive diagnosis of SARS-CoV-2 virus based on PCR with specific pulmonary involvement in radiography who have progressive hospital course (SpO2 <85% or RR > 30) despite receiving standard of care treatment protocols within 72 hours
排除标准
- •Participants in any other clinical trial for COVID-19
- •Concomitant treatment with other antiviral drugs other than those recommended in the national protocol
- •Patients undergoing mechanical ventilation at the time of baseline
- •Evidence of multiorgan failure in the patient's clinical record based on the physician's diagnosis
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above 5 times the upper limit of normal (ULN)
- •Creatinine clearance less than 50 ml/min
- •The presence of any concurrent major diseases including malignancy, advanced heart failure, cirrhosis, chronic kidney disease, stroke, Alzheimer's, chronic progressive neurological diseases, etc.
- •Pregnant and lactating women
- •Possibility of being transferred to another hospital with no access to the study drug (for any reason)
研究者
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