Non-Interventional Observational Study Assessing Safety And Efficacy Of Neutralizing Monoclonal Antibody (Casirivimab/ Imdevimab) Treatment In A Real-World-Setting Of Mild/Moderate Covid-19 Patients In India
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 9
- 主要终点
- The purpose of this study is to assess the real-world safety and efficacy of neutralizing monoclonal antibody (casirivimab/imdevimab) treatment in mild/moderate COVID-19 patients in India, who are at high risk of severe COVID-19 and do not require oxygen
研究概览
简要总结
This is a non-interventional, single-arm, observational study with primary prospectivedata collection (NIS PDC) and retrospective collection of prior medical/treatment historydata from medical records. Mild/moderate Covid-19 patients, who are prescribedtreatment with the neutralizing monoclonal antibody (casirivimab and imdevimab) as perthe Emergency Use Authorization in India will be followed up for safety and efficacy upto Day 90. All treatment choices in this study will be at the discretion of the treatingphysician according to local standard of care or best practice and are independent ofparticipation in this study. No additional laboratory or other diagnostic tests will beperformed on patients due to their participation in this study. No study-specific site visitsare mandated by the study protocol
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 12.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •confirmed covid-19 infection
- •Does not require oxygen
- •Symptoms are mil/moderate 4 At high risk for sever Covid 19 infection.
排除标准
- •hospitalized due to COVID-19
- •Require oxygen therapy due to Covid-19
- •Require an increase in baseline oxygen flow rate due to Covid-19.
结局指标
主要结局
The purpose of this study is to assess the real-world safety and efficacy of neutralizing monoclonal antibody (casirivimab/imdevimab) treatment in mild/moderate COVID-19 patients in India, who are at high risk of severe COVID-19 and do not require oxygen
时间窗: The neutralizing antibody will be administered at the baseline visit (Day 0). Visits 1, 2, 3 and 4 will be conducted by phone, at days 7, 14, 28 and 90. Data Collected during Observational Period.
次要结局
- the rate of Covid-19 related healthcare resource utilization including, but not limited(to emergency room visits, urgent care/unscheduled visits, and rehabilitation)