临床试验/NCT04556318

NCT04556318已完成不适用

Study to Identify Differences of Exhaled Breath Components Using Ion Mobility Spectrometry (IMS) in Patients Tested Positive or Negative on SARS-CoV-2

B. Braun Melsungen AG2 个研究点分布在 1 个国家目标入组 396 人开始时间: 2020年9月23日最近更新: 2021年7月8日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: B. Braun Melsungen AG
入组人数: 396
试验地点: 2
主要终点: SARS-CoV-2 related volatile organic compounds (VOC)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Breath analysis is the evaluation of exhaled air of humans. It aims to get information about the clinical status of a human being by monitoring its volatile organic compounds (VOCs) in exhaled air.

In this feasibility study it is intended to find specific biomarker(s) in exhaled breath indicating an infection with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).

研究设计

研究类型: Observational
观察模型: Cohort
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: 否

入选标准

•SARS-CoV-2-Polymerase chain reaction (PCR) test result is available
•Signs or symptoms of any respiratory system infection or Signs or symptoms indicating SARS-CoV-2 infection or Radiological findings suggesting viral lung infection
•Breath test (Study intervention) must be performed within a 2 day time period after latest SARS-CoV-2 PCR

排除标准

•History of SARS-CoV-2 outside the current respiratory episode (known from medical history)
•Participation in another clinical study prior to breath analysis which could influence the result of the breath analysis

结局指标

主要结局

SARS-CoV-2 related volatile organic compounds (VOC)

时间窗: 1 hour after breath gas sampling

次要结局

To compare the SARS-CoV-2 specific VOC with the clinical symptoms of COVID-19 and diagnostic findings(Within 3 days)

研究者

发起方

B. Braun Melsungen AG

申办方类型

Industry

责任方

Sponsor

研究点 (2)

Loading locations...

相似试验

招募中

不适用

Analysis of Exhaled Breath From Patients With Lung-/Airway Diseases (BigExBrESs)Lung-/Airway Diseases

NCT05458934University of Zurich5,000

已完成

不适用

Differences in Exhaled Breath by Using Ion Mobility Spectrometry (IMS) in Subjects Tested for SARS-CoV-2 Infection (COVID-19 Disease)SARS (Severe Acute Respiratory Syndrome)Covid19

NCT04649931B. Braun Melsungen AG450

已完成

不适用

Breath Analysis in Healthy ControlsExhaled BreathMass SpectrometryHealthy Subjects

NCT02595632University of Zurich183

终止

不适用

Exhaled Breath Analysis to Predict Risk of Symptomatic PneumonitisPneumonitisNonsmall Cell Lung Cancer Stage III

NCT04040244Wake Forest University Health Sciences16

招募中

不适用

Exhaled Breath Analysis in Human SubjectsExhaled Breath Pattern After Medication Intake, in OSA Patients, or Other Pulmonary Diseases

NCT05456009University of Zurich1,500