NCT04369365已完成2 期
A Single-blinded, Randomized, Placebo Controlled Phase II Trial of Prophylactic Treatment With Oral Azithromycin Versus Placebo in Cancer Patients Undergoing Antineoplastic Treatment During the Corona Virus Disease 19 (COVID-19) Pandemic
Prof. Dr. Matthias Preusser1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2020年4月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Cumulative number of severe acute respiratory syndrome corona virus 2 (SARS-COV-2) infections
研究概览
简要总结
Prophylactic treatment in cancer patients undergoing antineoplastic therapy during the COVID-19 pandemic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed cancer diagnosis
- •Ongoing systemic antineoplastic treatment irrespective of application route
- •Age ≥ 18 years
- •Life expectancy of at least 3 months
- •Adequate renal, cardiac and liver function
- •Corrected QT time (QTc) ≤ 450 ms
- •Eastern Cooperative Oncology Group (ECOG) performance status of < 3
- •Capable of understanding the study and giving informed consent
- •Negative COVID-19 test at study entry as measured by routine testing
排除标准
- •Use of any investigational agent within 28 days prior to study start
- •Patients with active opportunistic infections
- •Pregnant or lactating women
- •Women of childbearing potential and male subjects not willing to use adequate contraception methods during the study period
- •Hypersensitivity to azithromycin or other macrolides
- •Concurrent medication with ergotamine, theophylline, digitalis
- •Inability to swallow tablets
研究组 & 干预措施
Arm A: Azithromycin
Active Comparator
weekly oral azithromycin 1500mg for a maximum of 8 weeks
干预措施: Azithromycin 500 milligram (mg) oral Tablet (Drug)
Arm B: Placebo
Placebo Comparator
weekly oral placebo for a maximum of 8 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Cumulative number of severe acute respiratory syndrome corona virus 2 (SARS-COV-2) infections
时间窗: 12 weeks after initiation of therapy
assessed by positive polymerase chain reaction (PCR) from routine nasal swabs (performed every 28 days)
次要结局
- Number of severe COVID-19 cases(12 weeks after initiation of therapy)
- Severity of COVID-19 cases(12 weeks after initiation of therapy)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](12 weeks after initiation of therapy)
- Number of viral and bacterial infections(12 weeks after initiation of therapy)
- Number of participants with azithromycin-resistant bacterial strains in nasal swabs test(12 weeks after initiation of therapy)
研究者
Prof. Dr. Matthias Preusser
Prof. Dr.
Medical University of Vienna
研究点 (1)
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