跳至主要内容
临床试验/NCT04527614
NCT04527614已完成不适用

Influence of Prior Infection With COVID-19 on Occurrence of Influenza-like Illness or Acute Respiratory Infection (PICOV) A Multicentre Academic Prospective Cohort Study in Nursing Home During the Winter Season 2020-2021

Sciensano1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年9月24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
发起方
Sciensano
入组人数
1,000
试验地点
1
主要终点
Time to occurrence of ILI and ARI both in participants previously exposed to SARS-COV-2 and controls

研究概览

简要总结

Background: Each Belgian winter season is characterized by a wave of influenza like and respiratory symptoms. Especially, the elderly people are more vulnerable to be infected by influenza, but also RSV. The recent COVID-19 pandemic and eventually a next wave, will increase the prevalence of influenza like and respiratory symptoms.

Method: A multicentre non-commercial cohort study will be conducted in nursing home staff and residents during the Winter season 2020-2021.

Objectives: Primary objective is the difference in incidence of influenza like and respiratory symptoms between cases (cases have evidence of past infection with SARS-CoV-2, referred to as Covid +) and controls (controls have no evidence of previous infection and are referred to as Covid -). The primary outcome analysis as well as the secondary outcome analyses will use two strata: nursing home staff and nursing home residents. The secondary objectives are the difference in incidence of COVID-19, influenza, RSV infections confirmed by PCR between cases and controls, to define a correlate of protection in the covid + group against re-infection with SARS-CoV-2 based on the study of the pre-existing antibody profile (antigen specificity, antibody type and antibody level) at the time of re-exposure. A multiplex assay will be used to assess the antibody profile. Finally, to study the COVID-19 disease severity (7 point WHO ordinal scale, this includes a.o. hospitalisation, mechanical ventilation need and ICU admission, mortality) based on the presence/absence of pre-existing antibodies and the pre-existing antibody profile. For other respiratory infections we will study the need for hospitalization and mortality.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •Being a staff member or resident from te participating nursing homes
  • •The subject should be aged 18 years or older, have a Belgian National Number and be insured by a Belgian sickness fund.
  • •All subjects that are cognitively capable to give consent themselves to participate in the study.

排除标准

  • •Insufficient knowledge of the Dutch or French language.
  • •Residents with a previous diagnosis of dementia having a mini-mental state examination (MMSE) below 18/
  • •Participants which life-expectancy is less than the time of the study.
  • •Staff members not expected to continue working at the nursing home during the winter season.
  • •Participants for whom veins are not accessible for simple periphery blood puncture.

研究组 & 干预措施

COVID+

Other

Participants with a previous SARS-CoV-2 infection

干预措施: qRT-PCR and serology (Diagnostic Test)

COVID-

Other

Participants without a previous SARS-CoV-2 infection

干预措施: qRT-PCR and serology (Diagnostic Test)

结局指标

主要结局

Time to occurrence of ILI and ARI both in participants previously exposed to SARS-COV-2 and controls

时间窗: up to 8 months

This study will assess the time to the occurrence of influenza-like illness (ILI) or acute respiratory infection (ARI) in subjects previously COVID+ compared to subjects known as COVID- (controls), more specifically subjects will belong to two subgroups: nursing home residents (65+) and nursing home staff (18-65y). COVID+ is defined as a past SARS-CoV-2 infection.

次要结局

  • Correlation of the pre-existing antibody characteristics for COVID-19 with disease severity.(up to 8 months)
  • Correlation of the level of neutralization antibodies against influenza subtypes with protection against influenza reinfection(up to 8 months)
  • Validation of (SimplySpiro) to replace nasopharyngeal swabs(up to 8 months)
  • Number of patients with ILI or ARI, diagnosed with COVID-19, influenza, RSV(up to 8 months)
  • Identify the antibody characteristics in participants with reinfection with SARS-CoV-2(up to 8 months)

研究者

发起方
Sciensano
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Maria Goossens

MD, PhD

Sciensano

研究点 (1)

Loading locations...

相似试验