Geriatrics Unit and the GeroCovid Working Group, Department of Medicine (DIMED), University of Padua, Italy.
Bluecompanion Ltd, London, UK.
Eur J Intern Med. 2021 May;87:29-35. doi: 10.1016/j.ejim.2021.01.017. Epub 2021 Jan 31.
Despite the growing evidence on COVID-19, there are still many gaps in the understanding of this disease, especially in individuals in advanced age. We describe the study protocol of GeroCovid Observational, a multi-purpose, multi-setting and multicenter initiative that aims at investigating: risk factors, clinical presentation and outcomes of individuals affected by COVID-19 in acute and residential care settings; best strategies to prevent infection in long-term care facilities; and, impact of the pandemic on neuropsychologic, functional and physical health, and on medical management in outpatients and home care patients at risk of COVID-19, with a special focus on individuals with dementia.
GeroCovid involves individuals aged ≥60 years, at risk of or affected by COVID-19, prospectively or retrospectively observed since March 1, 2020. Data are collected in multiple investigational sites across Italy, Spain and Norway, and recorded in a de-identified clinical e-Registry. A common framework was adapted to different care settings: acute wards, long-term care facilities, geriatric outpatient and home care, and outpatient memory clinics.
At September 16, 2020, 66 investigational sites obtained their Ethical Committee approval and 1618 cases (mean age 80.6 [SD=9.0] years; 45% men) have been recorded in the e-Registry. The average inclusion rate since the study start on April 25, 2020, is 11.2 patients/day. New cases enrollment will ended on December 31 , 2020, and the clinical follow-up will end on June 30, 2021.
GeroCovid will explore relevant aspects of COVID-19 in adults aged ≥60 years with high-quality and comprehensive data, which will help to optimize COVID-19 prevention and management, with practical implications for ongoing and possible future pandemics.
NCT04379440 (clinicaltrial.gov).
尽管关于 COVID-19 的证据不断增加，但人们对这种疾病的认识仍存在许多空白，尤其是在老年人中。我们描述了 GeroCovid 观察研究的研究方案，这是一项多用途、多环境和多中心的倡议，旨在研究：在急性和住院护理环境中感染 COVID-19 的个体的危险因素、临床表现和结局；在长期护理机构中预防感染的最佳策略；以及大流行对神经心理、功能和身体健康的影响，以及对门诊和有 COVID-19 风险的家庭护理患者的医疗管理，特别关注痴呆症患者。
GeroCovid 涉及年龄≥60 岁的个体，自 2020 年 3 月 1 日起，前瞻性或回顾性观察这些个体感染 COVID-19 的风险或已感染 COVID-19。数据在意大利、西班牙和挪威的多个研究地点收集，并记录在一个匿名的临床电子登记处。一个共同的框架被改编用于不同的护理环境：急性病房、长期护理机构、老年门诊和家庭护理，以及门诊记忆诊所。
截至 2020 年 9 月 16 日，66 个研究地点获得了伦理委员会的批准，1618 例患者（平均年龄 80.6[SD=9.0]岁；45%为男性）已被记录在电子登记处。自 2020 年 4 月 25 日研究开始以来，平均每天纳入 11.2 例患者。新病例的入组将于 2020 年 12 月 31 日结束，临床随访将于 2021 年 6 月 30 日结束。
GeroCovid 将使用高质量和全面的数据探索 COVID-19 对年龄≥60 岁成年人的相关方面，这将有助于优化 COVID-19 的预防和管理，对当前和未来可能的大流行具有实际意义。
NCT04379440（clinicaltrial.gov）。
