跳至主要内容
临床试验/NCT04788433
NCT04788433已完成不适用

ROCCO - Registry of Coronavirus Complications. Prospective Observational Study on Coronavirus Complications and Correlation With Glycomic Profile in COVID-19 Patients

Papa Giovanni XXIII Hospital1 个研究点 分布在 1 个国家目标入组 374 人开始时间: 2021年3月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
374
试验地点
1
主要终点
Glycomic profile as predictor of long-term morbidity

研究概览

简要总结

COVID infection has resulted in multi-organ injury and may result in cardiovascular, pulmonary, neurological, and muscular damage. It is associated with significant asthenia and the long-term effects of the infection are still unclear, particularly for the development of pain and delayed functional rehabilitation.

Glycomics "is the systematic study of the structure of glycans in a given cell type or organism. Glycans are complex oligosaccharides attached to proteins and lipids that regulate a variety of organic processes, including immunity Thus, glycans may influence different moments of the response to the virus and involved in the clinical severity of the disease, but may also change depending on the severity of symptoms and the organic response to SARS-CoV-2 infection.

Glycomic data could provide important insights into interindividual differences at the molecular level that directly interact with SARS-CoV-2 and the development of mid- and long-term side effects. The ability to identify early those susceptible to developing COVID-19 infection and at higher risk for COVID-19 with unfavorable outcomes long after infection would help guide therapeutic strategy and provide important guidance for rational health care organization, which is of outmost importance.

Long-term outcome data regarding post-COVID patient functional capacity and glycomics will be compared to assess whether there may be differences in protein glycosylation that may predict patient outcome.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Confirmed diagnosis of COVID19 virus infection (buffer/BAL/positive IgG serology)
  • Age >18 years
  • Able to express informed consent to participate in the study

排除标准

  • patients unable to express consent,
  • patients aged <18 yr,
  • with signs and symptoms compatible with Covid-19 but without certified diagnosis by swab/BAL or serological examination of presence of COVID IgG antibodies

结局指标

主要结局

Glycomic profile as predictor of long-term morbidity

时间窗: 1 year

Analysis of total plasmatic and IgG glycans composition; analysis of IgG glycopeptides. Correlation with pain, severity of the disease and long-term functional rehabilitation

次要结局

未报告次要终点

研究者

发起方
Papa Giovanni XXIII Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dario Bugada

Anesthesiologist

Papa Giovanni XXIII Hospital

研究点 (1)

Loading locations...

相似试验