Neurobiological Underpinnings of Neuropsychological Consequences in Long COVID: Exploration of Two Translational Pathways
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Concentration of immunological and HPA-axis markers
研究概览
简要总结
Objectives:
To describe the standardized evaluation of the psychological and cognitive function of long COVID patients and their evolution, to compare immunological and HPA-axis related biomarkers between long COVID patients and healthy controls, to explore cross-sectional and longitudinal associations between immunological measures and long COVID symptoms.
Study design:
Cov-N-Psy is a longitudinal observational study. Three groups will be included from 2021 until 2023: long COVID patients with neuropsychological complaints (P), COVID-survivors without persistent complaints (Ca) and healthy volunteers without a history of COVID-19 (Cb). The total sample size is estimated on 130. Four visits are organized: at baseline, three, six and twelve months.
The study is organized in three work packages (WP). WP1 includes a blood withdrawal and psychometric questionnaires and is part of every visit. WP2 includes cortisol measurement in saliva and takes place on the baseline visit for every participant and on the third visit for patients. Finally, WP3 includes a neurocognitive assessment at baseline for patients and Ca controls and on the third visit for patients.
详细描述
Research Objectives
Describe the standardized evaluation of the psychopathological and neurocognitive function of long COVID NP patients and their evolution over time; Compare the immunological profile and the cortisol awakening response (CAR) of long COVID NP patients to those of COVID-19 survivors without persistent complaints and healthy uninfected controls; Explore the cross-sectional and longitudinal association between long COVID NP symptoms and immunological and cortisol measures.
Methodology
Recruitment and study population
Inclusion criteria - patients:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria - patients:
- •18-70 years
- •Diagnosis of long COVID
- •(Neuro)psychological symptoms >4 weeks after infection
- •Infection with SARS-Cov-2 was detected with PCR (or antigen test)
- •Other causes for their complaints are excluded by their GP or specialist
- •Positive score on at least 2 NP domains during the screening phase
- •Inclusion criteria - control a:
- •18-70 years
- •No prolonged symptoms due to SARS-CoV-2 infection within 4 weeks after infection
- •No current (Neuro)psychological symptoms
- •Infection with SARS-Cov-2 was detected with PCR (or antigen test)
- •A positive score on maximum one domain (psychological / cognitive) is allowed in the absence of a psychiatric diagnosis (confirmed by the MINI) and when the complaint causes significant distress (which is investigated during the screening phase).
- •Inclusion criteria - control b:
- •18-70 years
- •No (known) infection with SARS-CoV-2
- •No current or previous (neuro)psychological symptoms
排除标准
- •General exclusion criteria:
- •Participant is unable to read and understand the consent form and patient-reported outcomes, complete study-related procedures, or communicate with the study staff and informed consent cannot realistically be obtained in retrospect or with the help of a competent family member or legal representative.
- •Exclusion criteria for each subgroup:
- •HPA subgroup
- •Participant is pregnant or breastfeeding
- •Participant receives hormonal replacement therapy (contraception is allowed).
- •Participant is treated with cortisol <4 weeks ago
- •Neurocognitive assessment:
- •IQ < 90 (screened with Raven Standard Progressive Matrices (Short Form) (RSPM-SF) (39)
- •Participant takes sedative medication
- •Benzodiazepines: Larger than the equivalent of diazepam 10mg per day. Last administration <8 hours prior to the neurocognitive tests.
- •New sedative antipsychotics/antidepressants (<4 weeks)
- •Other medication from DRUID class III (<4 weeks), last administration <8 hours prior to the neurocognitive tests, or causing significant sedation.
- •Severe substance abuse (alcohol + drugs)
- •Pre-existing neurological diseases that influence cognitive functioning
结局指标
主要结局
Concentration of immunological and HPA-axis markers
时间窗: Baseline (11/2021-12/2023) - FU (01/2022-12/2024)
Compare the immunological profile and the cortisol awakening response (CAR) of long COVID NP patients to those of COVID-19 survivors without persistent complaints and healthy uninfected controls
次要结局
- Cross-sectional and longitudinal association between long COVID NP symptoms (BDI, HDRS, STAI, ISI, KEDS, FSS, NP battery ...) and immunological and cortisol measures (CAR, cytokines, serology, WBC, CRP, mitochondrial markers, TRYCATS, ...)(Baseline (11/2021-12/2023) - FU (01/2022-12/2024))
- Rate of psychopathological and neurocognitive function of long COVID patients with neuropsychiatric complaints(Baseline (11/2021-12/2023) - FU (01/2022-12/2024))
研究者
Dr Livia De Picker
Clinical Professor
Universiteit Antwerpen