Post-COVID-19 Outpatient Care and Biomarkers for Persisting Symptoms of Post-COVID-19 Disease - A Prospective Registry and Biobank
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Change in circulating biomarkers
研究概览
简要总结
The aims of this case-control, non-randomized study including patients with post-COVID-19 persisting symptoms are 1) to establish the large blood biobank, 2) to examine levels of circulating inflammatory biomarkers and different classes of non-coding RNAs (ncRNA), such as selected circRNAs and miRNAs, in plasma and serum samples collected from patients with post- COVID-19, 3) to test the levels of cfDNA in plasma and serum, 4) to define correlation between ncRNAs and cf-DNA with persistent clinical symptoms, and type of symptoms, and 5) to investigate diagnostic and prognostic performances of these circulating biomarkers.
Study design. This is a prospective registry including biobank.
详细描述
Currently, several studies are ongoing to investigate different treatment modalities of post-COVID-19 symptoms, but there is a complete lack of investigations on biomarkers predicting type, duration or severity of post-COVID-19 symptoms. The aim of this study is to investigate circulatory biomarkers diagnostic or predictive for long/post-COVID-19 syndrome.
Study patients. Patients with at least 3 weeks after proven infection by SARS-CoV-2, reflected by at least one positive PCR-test in nose throat swabs, who visits at the Post-COVID-19 outpatient clinic of the Medical University of Vienna, will be consequently recruited into the presented registry. Additionally, 100 vaccinated patients with HFrEF and 100 healthy vaccinated volunteers will be recruited to serve as comparison groups.
Methods. Identity of the registry patients will be protected by pseudonymization. During the ambulatory visit, basic clinical examination, electrocardiogram, chest X-ray, routine laboratory tests will be performed. Additionally, venous blood will be collected for biobank.
Expected Outcome This registry will provide further insights regarding pathophysiology, risk stratification and treatment of complex post-COVID-19 symptoms. Specific therapies and search of prognostic factors will enable to select patients with high risk of persistence or worsening of their symptoms thereby improve patient care.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For post-COVID patient group:
- •Age≥18to90years
- •Proven infection by SARS-CoV2, at least 3 weeks after recovery from the infection
- •Signed informed consent For HFrEF patient group:
- •For vaccinated healthy volunteer control group:
- •Full vaccination against SARS-CoV2 at least 3 weeks before inclusion in the study
- •Signed informed consent
排除标准
- •non-willingness to participate or withdrawal of informed consent
- •Clinically confirmed HFrEF (EF <40%)
- •participation in any SARS-CoV-2 medical treatment trial
- •pregnancy
结局指标
主要结局
Change in circulating biomarkers
时间窗: 3 years
circularRNA
次要结局
- Change in circulating proteins(3 years)
- Change in neutralizing antibodies(3 years)
- Changes in ECGs(3 years)
- Cardiac magnetic resonance imaging abnormalities(3 years)
研究者
Mariann Gyongyosi
Principal Investigator
Medical University of Vienna