PACTR202008855701534尚未招募2 期
A Randomized, Open Label Trial to Investigate the Efficacy and Safety of Nitazoxanide Plus Atazanavir/Ritonavir for the Treatment of COVID-19: a Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 98
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
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •Willingness and ability to provide written informed consent
- •At least 18 and not more than 75 years of age at study entry
- •SARS-CoV-2 infection confirmed by PCR test within 4 days before randomization
- •Currently symptomatic (fever or chills, cough, myalgia, sore throat, shortness of breath, or new onset of anosmia or ageusia) and at COVID-19 isolation and treatment centre
排除标准
- •Inability to take orally administered medication or food
- •Known hypersensitivity to study medication
- •Pregnant or lactating (unless practicing exclusive replacement feeding for the entire study duration)
- •Participation in any other interventional trial for COVID-19 (observational study co-enrollment allowed)
- •Concurrent treatment with other agents with actual or possible direct-acting antiviral activity against SARS-CoV-2 less than 24 hours prior to study drug dosing
- •Concurrent use of agents with known or uncertain interaction with study drugs, including ritonavir
- •Requiring mechanical ventilation at screening
- •Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) above 5 times upper limit of normal (ULN)
- •Creatinine clearance below 50 mL/min using the Cockcroft-Gault formula for participants above 18 years of age
- •Recent history of or currently having a noncommunicable disease (e.g. cardiovascular disease, cancer, chronic respiratory diseases and diabetes)
研究者
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