An International Randomized Trial of Additional Treatments for COVID-19 in Hospitalized Patients Who Are All Receiving the Local Standard of Care Philippines
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,314
- 试验地点
- 25
- 主要终点
- All-cause mortality
研究概览
简要总结
This study is an adaptive, randomized, open-label, controlled clinical trial utilizing an adaptive design to compare effects of repurposed drugs with local standard of care alone on major inpatient hospital outcomes. This is performed worldwide in collaboration with WHO.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Consenting adults (age ≥18) hospitalised with the following criteria will be included in the study:
- •Probable or confirmed COVID-19 regardless of severity, i.e., mild, moderate and severe cases
- •Not already receiving any of the study drugs
- •Without known allergy or contraindications to any of the study drugs (in the view of the physician responsible for their care), and
- •Without anticipated transfer within 72 hours to a non-study hospital.
排除标准
- •Patients with contraindications to any of the study drugs.
研究组 & 干预措施
ACB+LSoC
Acalabrutinib with Local Standard of Care
干预措施: Acalabrutinib (Drug)
IFN+LSoC
Interferon Beta 1a with Local Standard of Care
干预措施: Interferon beta-1a (Drug)
Rem+LSoC
Remdesivir with Local Standard of Care
干预措施: Remdesivir (Drug)
HCQ+LSoC
Hydroxychloroquine with Local Standard of Care
干预措施: Hydroxychloroquine (Drug)
Lopi/Rito+LSoC
Lopinavir/Ritonavir with Local Standard of Care
干预措施: Lopinavir / Ritonavir (Drug)
Lopi/Rito+IFN+LSoC
Lopinavir/Ritonavir and Interferon Beta 1a with Local Standard of Care
干预措施: Lopinavir / Ritonavir (Drug)
Lopi/Rito+IFN+LSoC
Lopinavir/Ritonavir and Interferon Beta 1a with Local Standard of Care
干预措施: Interferon beta-1a (Drug)
结局指标
主要结局
All-cause mortality
时间窗: Number of days from hospital admission up to 28 days post discharge
次要结局
- Time to first receiving ventilation(Number of days from hospital admission to day of receiving ventilatory support up to 28 days post admission)
- Duration of hospital stay(Number of days from hospital admission to discharge up to 28 days post admission)
研究者
Marissa Alejandria MD
Professor
University of the Philippines