Geriatric Population COVID-19 Syndromic Characteristics and Clinical Outcomes: a Multi-setting, Multi-domain Observational Study (GEROCOVID Observational)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,500
- 试验地点
- 7
- 主要终点
- Incidence of Serious Adverse Events
研究概览
简要总结
The GeroCovid e-Registry is a European de-identified clinical data electronic registry of geriatric patients at risk or suffering from COVID-19 (suspected and confirmed cases) observed since 1st March 2020 in the participating investigational sites.
详细描述
Older adults (≥ 65 years) and pre-geriatric population (≥60 years and <65 years) are the ones most at risk from complications of COVID-19, including increased mortality, possibly in relationship with their comorbidity and frailty status.
The GeroCovid e-registry is intended to track Covid-19 pandemic impact on the general geriatric population and on age/care-setting related sub-populations.
The analysis of results is expected to facilitate the adoption of optimal standard of geriatric care during the pandemic.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Applying only to the " Acute Ward Patients " cohort:
- •Hospitalised patients
- •Suspected or known SARS-CoV-2 infection
- •Applying only to the "Nursing Homes (RSA)" cohort:
- •Nursing Home Resident Older Adults
- •Suspected or known SARS-CoV-2 infection
- •Applying only to the" Home and outpatients' care " cohort:
- •a. Outpatients at risk of SARS-CoV-2 infection
- •Applying only to the" Dementia outpatients " cohort:
- •Outpatients suffering from dementia according to NIA-AA criteria
- •At risk of SARS-CoV-2 infection
- •Ongoing treatment with anti-cholinesterase- dugs and/or anti-psychotics
- •Applying only to the" At home " cohort:
- •a. Outpatients at risk of SARS-CoV-2 infection
- •Applying only to the " Outcomes " cohort:
- •Age≥65 years
- •Hospitalised patients diagnosed with SARS-CoV-2 infection
排除标准
- •Lack of a signed Informed Consent if the patient received and understood the information about the study.
- •Lack of a signed declaration by the responsible physician stating that no explicit opt-out advanced directives by the subject were known to be in place at the moment of inclusion if it had been impossible to inform the patient due to her/his state of consciousness and/or awareness of disease condition.
结局指标
主要结局
Incidence of Serious Adverse Events
时间窗: 60 days or less in case of early termination
Incidence and duration of hospitalisation, incidence of Death and other Serious Adverse Events;
Health status (WHO classification)
时间窗: 60 days or less in case of early termination
Change of health status according to WHO classification versus baseline after 60 days, or after any interval (last performed observation) in the event of early study termination (whole sample).
次要结局
- Incidence of outcomes in the " Outcomes " cohort per Frailty Status(60 days or less in case of early termination)
- COVID-19 prevalent symptoms at onset(Day0)
- Instrumental Daily Life function in the "Dementia" and "At home " cohorts(60 days or less in case of early termination)
- Incidence of COVID-19 in the RSA cohort(60 days or less in case of early termination)
- COVID-19 Prognostic Factors(Day0)
- Cognitive function in the "Dementia" and "At home " cohorts(60 days or less in case of early termination)
- Affective/mood state change from baseline in the " At home " cohort(60 days or less in case of early termination)
- Residual signs and symptoms in the " Outcomes " cohort(60 days or less in case of early termination)
- Incidence of outcomes in the " Outcomes " cohort per Comorbidity burden at baseline(60 days or less in case of early termination)
- Daily Life Function in the "Dementia" and "At home " cohorts(60 days or less in case of early termination)
研究者
Raffaele Antonelli Incalzi
Full Professor in Internal Medicine, Director of Geriatrics Department and Acting Director of Chronic Diseases Department
Campus Bio-Medico University