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临床试验/NCT05439044
NCT05439044已完成不适用

A Real-World Study of Anti-SARS-CoV-2 Monoclonal Antibodies in Patients at High Risk of Severe Forms of Covid-19

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 4,235 人开始时间: 2021年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
4,235
试验地点
2
主要终点
Mortality rate

研究概览

简要总结

Absence of anti-SARS-CoV-2 vaccine response or insufficient vaccine response may occur in immunocompromised patients. Being at high risk of a severe form of Covid-19, they may be eligible to receive recombinant anti-SARS-CoV-2 monoclonal antibodies (mAbs). This study aims to describe patients who received anti-SARS-CoV-2 mAbs, in prophylaxis and/or curative of covid-19, and to analyze the hospitalization and mortality rates. This study is multicentric on all the university hospitals of Paris (AP-HP).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult ≥ 18 years old
  • Patients who received at least one administration of the following therapies: casirivimab-imdevimab, bamlanivimab-etesevimab, tixagevimab-cilgavimab, regdanvimab, sotrovimab or adintrevimab

排除标准

  • Patients opposed to the collection of their personal data

研究组 & 干预措施

Patients who have received an anti-SARS-CoV-2 monoclonal antibody

Patients who have received an anti-SARS-CoV-2 monoclonal antibody, either prophylactically or curatively.

干预措施: Data collection (Other)

结局指标

主要结局

Mortality rate

时间窗: 29 days after last administration

Covid-19 mortality : Explore the mortality rate related to COVID-19 in patients treated with anti-SARS-CoV-2 monoclonal antibodies

次要结局

  • Hospitalizations rate(90 days after last administration)
  • Proportion of deaths(90 days after last administration)
  • Proportion of hospitalizations(90 days after last administration)
  • Mortality rate(90 days after last administration)
  • Hospitalizations rate(29 days after last administration)
  • Mortality rate(29 days after last administration)
  • Proportion of hospitalizations(29 days after last administration)
  • Proportion of deaths(29 days after last administration)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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