Markers of Neurological Damage Post Covid-19 in People Living With HIV (PLWH)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Impact on neurological damage of COVID-19 in PLWH
研究概览
简要总结
Both HIV infection and Covid-19 are associated to cognitive and psychiatric impairment, like anxiety and depression. These disturbs are well-known in HIV infection and partially characterized in Covid-19.
详细描述
HIV has an high neurotropism and the HIV-associated dementia was one of the most frequent clinical complications and principal cause of death before the introduction of antiretroviral theraphy (ART). However, also in PLWH taking ART and with suppressed viral load over years, the proportion of neuro-cognitive impairment, anxiety and depression remain higher then the general population.
These problems may be the consequence of a persistent systemic and central nervous system (CNS) immuno-activation caused by the persistence of viral reservoir in the peripheric and tissutal lymphocytes.
Neurological and psychiatric problems have been described in a variable proportion in patients with corona virus disease 19 (COVID-19) and in the complex it doesn't seems to be the direct consequence of CNS cellular infection, but rather of inflammation and coagulations disorder due to COVID-19 in the nervous tissue.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HIV+ COVID+: people living with HIV that get corona virus disease 19 (COVID19) diagnosed at least 9 month ago with a positive rino-pharyngeal swab (molecular or antigenic), or with compatible clinic and a positive serologic test for Sars-CoV2 before the vaccination; Age > 50 years old, no gender.
- •HIV+ COVID-: people living with HIV that had not get COVID
- •Age>50 years; no gender.
- •HIV- COVID+: people without HIV that get COVID19 diagnosed at least 9 month ago with a positive rino-pharyngeal swab (molecular or antigenic), or with compatible clinic and a positive serologic test for Sars-CoV2 before the vaccination; Age > 50 years old, no gender.
- •HIV- COVID-: people without HIV that had not get COVID19 (healthy people and volunteers) Age>50 years; no gender.
排除标准
- •Inability to perform the neuro-cognitive or functional tests due to neurologic deficit (inability to writing, reading, understand how to perform the tests)
结局指标
主要结局
Impact on neurological damage of COVID-19 in PLWH
时间窗: Through study completion, an average of 1 year
Assessing the impact of COVID-19 in PLWH concerning the neurological damage, by measuring blood's markers like the Neurofilament Light Protein (NfL) and the Glial Fibrillary Acidic Protein (gFAP)
次要结局
- Frequency of neurocognitive and muscular (strength and balance) impairment(Through study completion, an average of 1 year)
研究者
Paola Cinque
Principal Investigator
Scientific Institute San Raffaele