Five-year Follow-up After Sars-CoV-2 Infection: Prevalence and Evolution of Post-acute Sequalae of COVID-19 (PASC)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 900
- 主要终点
- Prevalence of Post-Acute Sequelae of COVID-19 (PASC) assessed by standardized symptom checklist.
研究概览
简要总结
This multicenter, observational, retrospective-prospective study aims to evaluate the prevalence and trajectory of Post-Acute Sequelae of COVID-19 (PASC) approximately 5 years after SARS-CoV-2 infection. The study will re-contact participants from an established cohort of more than 3,000 individuals with microbiologically confirmed SARS-CoV-2 infection, including both hospitalized and non-hospitalized patients, previously followed in dedicated post-COVID outpatient clinics. Participants will undergo a structured telephone interview approximately 60 ± 3 months after infection, and those meeting predefined clinical criteria will be invited to an in-person clinical assessment. The study will evaluate persistent symptoms, functional status, cognitive and nutritional status, frailty, sarcopenia, quality of life, healthcare resource utilization, and direct and indirect healthcare costs to characterize the long-term trajectory of PASC.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Previous participation in the original cohort assessed at 6-12 months after the initial SARS-CoV-2 infection.
- •Persistence of symptoms beyond 3 months after infection, consistent with the WHO definition of Post-Acute Sequelae of COVID-19 (PASC).
- •Availability of clinical data related to the initial follow-up phase.
- •Provision of informed consent for study participation (for patients enrolled in the prospective cohort, informed consent will be obtained, while for retrospective participants, reference will be made to Article 110-bis of the Italian Privacy Code).
排除标准
- •Inability or refusal to complete follow-up procedures due to clinical, cognitive, or logistical reasons incompatible with the collection of essential study data.
- •Persistent inability to establish contact after multiple documented attempts.
- •Failure to provide informed consent.
研究组 & 干预措施
Post-COVID Cohort
Adults with a previous SARS-CoV-2 infection enrolled from an established post-COVID cohort and reassessed approximately five years after infection to evaluate the prevalence and evolution of post-acute sequelae of COVID-19 (PASC), including clinical, functional, cognitive, geriatric, and economic outcomes.
干预措施: Post-Acute Sequelae of COVID-19 (PASC) Assessment (Other)
结局指标
主要结局
Prevalence of Post-Acute Sequelae of COVID-19 (PASC) assessed by standardized symptom checklist.
时间窗: Approximately 60 ± 3 months after SARS-CoV-2 infection
The prevalence of Post-Acute Sequelae of COVID-19 (PASC) at approximately 5 years after SARS-CoV-2 infection will be assessed using a standardized checklist of persistent or newly developed symptoms compatible with PASC. The outcome will be reported as the proportion of participants presenting one or more PASC-related symptoms or clinically documented conditions.
次要结局
- Severity of post-acute sequelae of COVID-19 symptoms assessed by Fatigue Short Form 7a(Approximately 60 ± 3 months after SARS-CoV-2 infection.)
- Severity of post-acute sequelae of COVID-19 symptoms assessed by Modified Medical Research Council Dyspnea Scale.(Approximately 60 ± 3 months after SARS-CoV-2 infection.)
- Severity of post-acute sequelae of COVID-19 symptoms assessed by Perceived Deficits Questionnaire (PDQ-20).(Approximately 60 ± 3 months after SARS-CoV-2 infection.)
- Severity of post-acute sequelae of COVID-19 symptoms assessed by EuroQoL 5 Dimension 5 Level questionnaire (EQ-5D-5L).(Approximately 60 ± 3 months after SARS-CoV-2 infection.)
- Frailty, sarcopenia and nutritional status assessed by Clinical Frailty Scale.(Approximately 60 ± 3 months after SARS-CoV-2 infection.)
- Frailty, sarcopenia and nutritional status assessed by Primary Care-Frailty Index.(Approximately 60 ± 3 months after SARS-CoV-2 infection.)
- Frailty, sarcopenia and nutritional status assessed by Frailty Phenotype Score.(Approximately 60 ± 3 months after SARS-CoV-2 infection.)
- Frailty, sarcopenia and nutritional status assessed by Short Physical Performance Battery.(Approximately 60 ± 3 months after SARS-CoV-2 infection.)
- Frailty, sarcopenia and nutritional status assessed by handgrip strength measurement.(Approximately 60 ± 3 months after SARS-CoV-2 infection.)
- Frailty, sarcopenia and nutritional status assessed by Mini Nutritional Assessment.(Approximately 60 ± 3 months after SARS-CoV-2 infection.)
- Cognitive and psychiatric status assessed by Montreal Cognitive Assessment (MoCA).(Approximately 60 ± 3 months after SARS-CoV-2 infection.)
- Cognitive and psychiatric status assessed by Patient Health Questionnaire (PHQ-9).(Approximately 60 ± 3 months after SARS-CoV-2 infection.)
- Cognitive and psychiatric status assessed by Generalized Anxiety Disorder scale (GAD-7).(Approximately 60 ± 3 months after SARS-CoV-2 infection.)
- Healthcare utilization and costs assessed by healthcare resource utilization data and standardized questionnaires.(Approximately 60 ± 3 months after SARS-CoV-2 infection.)
研究者
Galluzzo Vincenzo
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS