NCT04302766No Longer Available不适用
Intermediate-Size Patient Population Expanded Access Treatment Protocol for Coronavirus Disease 2019 (COVID-19) Remdesivir (RDV; GS-5734™)
U.S. Army Medical Research and Development Command22 个研究点 分布在 8 个国家开始时间: 2020年3月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
- 试验地点
- 22
研究概览
简要总结
Disease caused by 2019 Novel Coronavirus also known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
详细描述
The treatment of communicable Novel Coronavirus (CODIV-19) of 2019 with Remdesivir (RDV; GS-5734™) also known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
研究设计
- 研究类型
- Expanded Access
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DoD-affiliated personnel as defined in DoDI 6200.02, which includes emergency-essential civilian employees and/or contractor personnel accompanying the Armed Forces who are subject to the same health risk as military personnel
- •Have a laboratory-confirmed COVID-19 diagnosis with moderate to severe disease presentation as determined by the principal investigator
- •Patient or legally authorized representative (LAR) provides written informed consent, except as noted in 21 CFR 50.23
- •Understands and agrees to comply with planned study procedures
- •Available for clinical follow-up for duration of the treatment and follow-up period
- •Woman of childbearing potential must
- •Have a negative pregnancy test within 24 hours before starting treatment
- •Agree not to become pregnant during treatment and for 1 months after receiving remdesivir (Treatment will be a maximum of 10 doses given over a 10-day interval)
- •Use at least 2 reliable forms of effective contraception, including 1 barrier method, during treatment and for 1 month after the treatment period
排除标准
- •ALT/AST ≥ 5 times the upper limit of normal
- •Stage 4 severe kidney disease or requiring dialysis (i.e. eGFR <30)
- •Anticipated transfer to another hospital that is not a study site within 72 hours
- •Allergy to any components of the study medication [GS-5734, sulfobutylether β-cyclodextrin sodium (SBECD) and hydrochloric acid and/or sodium hydroxide]
- •Concomitant antiviral therapy (lopinavir/ritonavir [Kaletra])
- •Pregnant or nursing
研究者
研究点 (22)
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