A Non-interventional, Prospective, Cross-sectional Study of the Incidence of Pulmonary, Cardiovascular and Renal System Non-communicable Complications Associated With the Post-acute Phase of the Infection by Sars-Cov-2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 345
- 试验地点
- 6
- 主要终点
- The incidence of any organ dysfunction during the first 48 months among patients of group C compared to group B
研究概览
简要总结
More than 660 million cases of COVID-19 have been reported worldwide, with 183 million cases in the EU alone. In several people, after recovery, the effects of the first waves of COVID-19 persisted beyond the acute phase and increased the risk of chronic multiorgan symptoms and disease. Up to 70% of people affected by COVID-19 showed reduced organ function even four months or more after COVID-19 diagnosis. Such a functional decline is associated with an increased risk of the development of non-communicable diseases (NCDs). Thus, there is an essential need for a better knowledge, tools, clinical guidelines and recommendations that it will make it possible to reduce this overrepresentation of NCDs as a consequence of the post-acute phase (PAP) of COVID-19.
The overall concept underpinning "POINT" is to i) build detailed knowledge on the link between the PAP of COVID-19 caused by previous, current, and future SARS-CoV-2 variants in vaccinated and unvaccinated people, and NCDs, ii) identify robust biomarkers and build predictive tools that help early identification and management of risk of NCDs, and iii) develop guidelines and recommendations for all parts of the healthcare value chain, allowing best prevention and care acknowledging vulnerability. The investigators will focus on the NCDs affecting pulmonary, cardiovascular and renal systems.
详细描述
Post-acute phase of COVID and Non-communicable diseases
Following the emergence of SARS-CoV-2, more than 660 million cases of COVID-19 have been reported worldwide, with 183 million cases in the EU alone. These numbers will continue to grow even after the disease becomes endemic. In some people, after recovery, the effects of the first waves of COVID-19 persisted beyond the acute phase and increased the risk of chronic multiorgan symptoms and disease. Up to 70% of people affected by COVID-19 showed reduced organ function even four months or more after COVID-19 diagnosis. Such a functional decline is associated with an increased risk of the development of non-communicable diseases (NCDs). This is especially true for individuals aged 65 and older as the risk of NCDs increases with age.
Diseases of the pulmonary, cardiovascular, and renal systems are the three major NCDs carrying the most significant burden for the individual as well as society. Studies have documented compromised function of these 3 organ systems in the PAP of COVID-19 in 30%-70% of patients, regardless of the severity of the acute-phase. As homeostasis of these three organs depends on interorgan communication with each other, the impact of PAP of COVID-19 on one will impact the others. The added stress of the PAP of COVID-19 increases the risk of a higher incidence and/or the risk of an accelerated progression of disease.
The prevalence and socioeconomic cost of the three NCDs is already extremely high. Without a strong focus on minimmising the increased risk of incidence and accelerated progression of the NCDs as a result of the PAP of COVID-19, up to 9 million Europeans may be affected and result in an added direct attributable cost of between 19.564 € - 31.064 € per year for each person who develop an NCD.
Beyond state of the art: pulmonary, cardiovascular and renal complications after the PAP of COVID-19
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group A (comparators)
- •Adults (18 years or more) of both genders
- •Negative history of acute COVID-19
- •Group B (patients with ΝΟ dysfunction)
- •Adults (18 years or more) of both genders
- •History of acute COVID-19 hospitalized or non-hospitalized. All cases appearing from start of the pandemic until the last six months may apply
- •Absence of any current overt organ dysfunction
- •Absence of signs of any organ dysfunction during acute COVID-19
- •Group C (patients with dysfunctions)
- •Adults (18 years or more) of both genders
- •History of acute COVID-19 hospitalized or non-hospitalized. All cases appearing from start of the pandemic until the last six months may apply
- •Presence of signs of organ dysfunction of the lung, the kidneys or the heart during acute COVID-19
排除标准
- •Group A (comparators)
- •Any other co-existing disorder generating clinical symptoms
- •Failure to thrive according to the attending physicians
- •Pregnancy or lactation
- •Group B (patients with ΝΟ dysfunction)
- •Any other co-existing disorder generating clinical symptoms
- •Failure to thrive according to the attending physicians
- •Pregnancy or lactation
- •Group C (patients with dysfunctions)
- •Any other co-existing disorder generating clinical symptoms
- •Medical history of any of:
- •stage III or IV chronic obstructive pulmonary disease according to the GOLD criteria
- •pulmonary fibrosis or pulmonary hypertension
- •stage IV solid tumour malignancy under chemotherapy or radiotherapy
- •systemic sclerosis
- •congestive heart failure
- •stage II, III or IV dyspnoea according to the New York Heart Association classification before the acute COVID-19
- •Limited chance of survival for at least six months due to co-existing comorbidity(-ies) according to the judgement of the attending physicians
- •Pregnancy or lactation
结局指标
主要结局
The incidence of any organ dysfunction during the first 48 months among patients of group C compared to group B
时间窗: From enrollment to Month 48
This is a composite endpoint which includes the development of chronic failures of at least one of lung, heart and/or kidneys
次要结局
- The incidence of any organ dysfunction during the first 48 months among patients of group C compared to group A.(From enrollment to Month 48.)
- The incidence of any organ dysfunction during the first 48 months among patients of group B compared to group A.(From enrollment to Month 48.)
- The incidence of chronic lung failure during the first 48 months among patients of group C compared to group B.(From enrollment to Month 48.)
- • The incidence of chronic heart failure during the first 48 months among patients of group C compared to group B.(From enrollment to Month 48.)
- • The incidence of chronic renal disease during the first 48 months among patients of group C compared to group B.(From enrollment to Month 48.)