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临床试验/NCT06401720
NCT06401720Enrolling By Invitation不适用

Respiratory Immune Responses in Human Influenza Virus Infection Across Age to Understand What Dictates Disease Severity

Karolinska Institutet5 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
800
试验地点
5
主要终点
Frequency of immune cells

研究概览

简要总结

The goal of this observational study is to understand immune responses to viral airway infection in adults, including the elderly. The main question(s) to answer is/are:

Why do some individuals acquire only asymptomatic or mild Influenza A virus (IAV) infection while others become severely ill and even succumb to the same disease?

Participants will be asked to donate samples when seeking health care for influenza-like symptoms or if hospitalized for IAV or SARS-CoV-2. Samples asked for are:

  • Blood sample by venepuncture
  • Blood sample by capillary sampling
  • Nasopharyngeal aspirate
  • Nasopharyngeal swab
  • Endotracheal tube aspirate
  • Nasal swab
  • Nasal curette
  • Breath Explor (sampling of expired air)

Researchers will compare obtained results with the same type of samples from healthy controls.

详细描述

This observational study will specifically investigate different immunological parameters in blood and at the site of infection in patients with IAV symptoms or confirmed infection to understand parameters related to disease course. Blood and airway samples will be analyzed for immune cell subsets and their functionality, antibodies and other soluble mediators and linked to clinical data. Immune cells will be analyzed using multi-color flow cytometry, RNA sequencing, and in vitro functionality assays. Fluids (plasma, serum, supernatants from airway samples and cell culture supernatants) will be analyzed using ELISA (and or similar methods), proximity extension assay (Olink), etc.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Frequency of immune cells

时间窗: Samples are taken at several different occasions when the patient is experiencing an airway infection and during convalescence. Samples are taken during a time frame of up to 6 months.

Flow cytometric analysis of white blood cell phenotype and frequency in PBMC, nasopharyngeal aspirate, nasopharyngeal swab, nasal swab, nasal curette, and endotracheal tube aspirate samples.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Smed Sörensen

Professor

Karolinska Institutet

研究点 (5)

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