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临床试验/NCT04981405
NCT04981405终止不适用

Real-world Evidence of COVID-19 Vaccine Effectiveness Against COVID-19 Hospitalization: the Case-control Study in St. Petersburg, Russia

Ivan S Moiseev2 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2021年7月16日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
182
试验地点
2
主要终点
Effectiveness of full vaccination against hospitalization with COVID-19 pneumonia

研究概览

简要总结

This is an observational case-control study to evaluate COVID-19 vaccine effectiveness against hospitalisation with COVID-19 related conditions in St. Petersburg, Russia. Two sets of cases and control will be retrospectively analyzed to compare vaccination proportions and other characteristics to infer vaccine effectiveness from odds ratios. The first set of cases will be extracted from the data on hospitalisation of patients with COVID-19 to First Pavlov State Medical University of Saint-Petersburg hospitals, and controls will be patients hospitalised with other conditions. The second set of cases and controls will be based on patients referred to Medical Institute named after Berezin Sergey for computed tomography. Cases will be patients with positive SARS-CoV-2 status computed tomography confirmed pneumonia or patients referred to hospitalisation, and control will be patients without pneumonia and not referred to hospitalisation.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Patients hospitalized to clinics of First Pavlov State Medical University of Saint-Petersburg
  • Patients referred to Medical Institute named after Berezin Sergey for computed tomography
  • Available vaccination status

排除标准

  • Refusal to provide information for research purposes at the time of hospitalization or reference to computed tomography

结局指标

主要结局

Effectiveness of full vaccination against hospitalization with COVID-19 pneumonia

时间窗: 3 months

Full vaccination effectiveness is calculated based on the odds ratio of vaccination proportions in cases and controls, adjusted for other patient characteristics. Full vaccination status is assigned after two weeks of the second dose for each vaccine separately.

次要结局

  • Effectiveness of partial vaccination against hospitalization with COVID-19 pneumonia(3 months)
  • Effectiveness of vaccination against hospitalization with COVID-19 pneumonia in different age groups(3 months)

研究者

发起方
Ivan S Moiseev
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ivan S Moiseev

Dr

St. Petersburg State Pavlov Medical University

研究点 (2)

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