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临床试验/NCT05794412
NCT05794412已完成不适用

Mucosal Immunity: Influence on Infectious Viral Load: a Prospective Observational Study

University Hospital, Geneva1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2023年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
320
试验地点
1
主要终点
SARS-CoV-2 infectious viral load

研究概览

简要总结

The goal of this observational study is to learn about the influence of pre-existing mucosal immunity, i.e. antibodies and immune cells that are present at the nasal mucosa before infection, on the infectious viral load after infection with SARS-CoV-2, influenza virus and RSV. The investigators will include app. 320 participants which will be followed for up to 17 months. During this time, the investigators will monitor their nasal mucosal antibodies at regular intervals and compare them to their infectious viral load if they are infected with SARS-CoV-2, influenza virus or RSV. Participants are invited to take a test for SARS-CoV-2, influenza virus or RSV in case of respiratory symptoms. If participants are positive the investigators will follow their viral load kinetics by taking nasopharyngeal swabs every 2-3 days. The investigators will also record the duration and strength of the following symptoms:

  • Cough
  • Fever
  • Tired
  • Sore throat
  • Difficulty breathing
  • Respiratory distress
  • Headache
  • Loss (or alteration) of smell
  • Loss (or alteration) of sense of taste
  • Myalgias
  • Chills
  • Subjective fever
  • Pink sputum (or coughing up blood)
  • Thoracic pain
  • Runny nose
  • Abdominal pain
  • Nausea
  • Vomiting
  • Diarrhea
  • Constipation
  • Irritated or watery eyes
  • Rashes
  • Other

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • In general good health, as determined by study investigators
  • All participants must be living in the canton of Geneva or working/studying in the canton of Geneva and living in neighboring communities that are within one hour travelling distance by car.

排除标准

  • Inability to provide written consent.
  • Severely immunocompromised subjects as determined by the study investigator
  • Treated with inhaled drugs by nasal route within the last month

结局指标

主要结局

SARS-CoV-2 infectious viral load

时间窗: up to 14 days post symptom onset

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

Isabella Eckerle

Prof.

University Hospital, Geneva

研究点 (1)

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