COVID-19 and Disease Progression to the Severe Form: a Multicentre Observational Study on the Use of Monoclonal Antibodies Against SARS-CoV-2 in Outpatients and Inpatients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 251
- 试验地点
- 1
- 主要终点
- Estimating the time to hospitalisation of patients with a confirmed diagnosis of SARS-CoV-2 infection receiving treatment with anti-SARS-CoV-2 monoclonal antibodies up to 30 days
研究概览
简要总结
This is a national multicentre observational study with retrospective and prospective data collection to assess the time to hospitalisation of patients with a confirmed diagnosis of SARS-CoV-2 infection receiving treatment with anti-SARS-CoV-2 monoclonal antibodies.
The subjects enrolled will be patients with early infection of SARS-CoV-2, paucisymptomatic, with risk factors for evolution to the severe form (according to AIFA criteria). Also, hospitalised subjects will be enrolled to receive SARS-CoV-2 monoclonal antibodies because of negative serology (according to AIFA criteria).
It is estimated to enrol about 1000 subjects.
Patients will be evaluated at enrollment and 28 days following administration to collect data on symptoms, possible hospitalization and final clinical outcome (alive with symptoms, alive without symptoms, alive with symptoms and hospitalized or deceased).
Data will be collected using a dedicated electronic Case Report Form (eCRF).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •>/= 18 years
- •Confirmed diagnosis of SARS-CoV-2 infection
- •Having received or receiving any anti-SARS-CoV-2 monoclonal antibody (or combination of monoclonal antibodies) prescribed through the AIFA registry
- •Signature of informed consent (for subjects enrolled in the prospective part)
排除标准
- •Absence of criteria for prescribing monoclonal antibodies as determined by AIFA
- •Patients already hospitalised for non-COVID reason at the time of monoclonal antibody administration
结局指标
主要结局
Estimating the time to hospitalisation of patients with a confirmed diagnosis of SARS-CoV-2 infection receiving treatment with anti-SARS-CoV-2 monoclonal antibodies up to 30 days
时间窗: 0-30 days
次要结局
- Estimating the COVID-19 lethality rate in patients receiving monoclonal antibodies (mAb) at 30 days.(0-30 days)
- Describing the evolution of COVID-19 symptoms in patients receiving mAb up to 30 days(0-30 days)
- Identifying possible predictive factors of hospitalisation(0-30 days)
- Describing the clinical progression of patients receiving casirivimab/imdevimab while hospitalized up to 30 days(0-30 days)
研究者
Paolo Bonfanti
Director of Infectious Diseases Department
University of Milano Bicocca