Real-world Effectiveness of Oral Antivirals for Treatment of COVID-19 in Ministry of Health Malaysia Institutions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 660
- 试验地点
- 8
- 主要终点
- Frequency and proportion of of study participants with COVID-19 related all-caused mortality
研究概览
简要总结
This study is a prospective observational cohort study to evaluate the benefit of oral antivirals (nirmatrelvir plus ritonavir or molnupiravir) in Ministry of Health institutions. In this study, we will observe the progress of COVID-19 study participants seen in the health clinic up to 90 days from their initial visit to the health clinic.
详细描述
This protocol is a prospective, multi-center, observational cohort study to evaluate the benefit of oral antivirals (nirmatrelvir plus ritonavir or molnupiravir) in Ministry of Health institutions in preventing progression of COVID-19 to severe COVID-19.
In this study, we will observe the clinical outcomes (COVID-19 symptoms, hospitalization admission, mortality, long term COVID-19 symptoms) of COVID-19 study participants seen in the health clinic up to 90 days from their initial visit to the health clinic . The hypothesis is that oral antiviral is beneficial in preventing disease progression and reducing long term COVID-19 symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •All SARS-CoV-2 positive individuals who are eligible for oral antiviral treatment based on current Ministry of Health Malaysia guidelines.
排除标准
- •Individual who received oral antiviral (either nirmatrelvir plus ritonavir or monupiravir) more than 5 days following their positive SARS-CoV-2 test date
研究组 & 干预措施
Oral Antiviral Group
Study participant initiated with oral antiviral (nirmatrelvir plus ritonavir or molnupiravir) for the treatment of COVID-19
干预措施: Oral Antiviral (Drug)
结局指标
主要结局
Frequency and proportion of of study participants with COVID-19 related all-caused mortality
时间窗: Within 28 days after treatment initiation
Any cause of death
Frequency and proportion of study participants with COVID-19 related Hospitalization
时间窗: Within 28 days after treatment initiation
Hospital admission due to COVID-19
次要结局
- Frequency and proportion of study participants with adverse drug reaction(Within 28 days after treatment initiation)
- Duration of Hospitalization(Within 28 days after treatment initiation)
- Frequency and proportion of study participants with of COVID-19 related symptoms(Within 28 days after treatment initiation)
- Frequency and proportion of study participants with COVID-19 ICU admission(Within 28 days after treatment initiation)
- Frequency and proportion of study participants with long-term COVID-19 symptoms(COVID-19 related symptoms lasting more than 4 weeks up to 6 months following COVID-19)