KCT0008328招募中Unknown
A multicenter, Adaptive, Randomised, Controlled Trial Platform to Evaluated Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Respiratory Infections
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 50
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(Year) 至 o Limit(—)
- 性别
- All
入选标准
- •1. Confirmation of SARS-CoV-2 infection by nucleic acid test (NAT) or equivalent non-NAT test [list of approved tests is in the PIM] collected within the prior 14 days.
- •2. Onset of symptoms attributable to SARS-CoV-2 infection occurred within 14 days before randomization.
- •3. Hospitalized for the management of COVID-19, with signs and/or symptoms suggestive of lower respiratory tract infection.
排除标准
- •1. Allergy to investigational agent or vehicle
- •2. Use of a concomitant medication that is contraindicated due to a drug-drug interaction with S-217622 (see section 6.3 and protocol instruction materials)
- •3. Moderate to severe hepatic impairment (i.e., Child-Pugh class B or C) or acute liver failure.
- •4. Known estimated glomerular filtration rate (eGRF) <30 mL/min/1.73m2
- •5. Continuous renal replacement therapy or chronic dialysis
- •6. Current pregnancy
- •7. Current breastfeeding and unwillingness to defer breastfeeding for 30 days after the last dose of investigational agent.
- •8. Women of child-bearing potential who are unwilling to abstain from sexual intercourse with men or practice appropriate contraception through 30 days from the last dose of the investigational agent.
- •9. Men who are unwilling to abstain from sexual intercourse with women of child-bearing potential or to use barrier contraception through 30 days from the last dose of the investigational agent.
- •10. Inability to take investigational agent in tablet form by mouth.
研究者
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