Five-year Follow-up After Sars-CoV-2 Infection: Prevalence and Evolution of Post-acute Sequalae of COVID-19 (PASC) (PASC-5Y)
2026年8月11日 更新者：Galluzzo Vincenzo、Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.
研究概览
地位
尚未招聘
研究类型
观察性的
注册 (估计的)
900
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Vincenzo Galluzzo, MD
- 电话号码：+390630153890
- 邮箱：vincenzo.galluzzo@policlinicogemelli.it
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
The study population consists of adults with a previous microbiologically confirmed SARS-CoV-2 infection who were enrolled in an established post-COVID cohort at Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Rome, Italy) and Fondazione IRCCS San Gerardo dei Tintori (Monza, Italy).
The original cohort includes more than 3,000 hospitalized and non-hospitalized patients followed after acute infection between April 2020 and September 2022.
Eligible participants will be re-contacted and reassessed approximately 5 years after SARS-CoV-2 infection to evaluate the long-term prevalence and evolution of post-acute sequelae of COVID-19 (PASC), functional, cognitive, nutritional, and economic outcomes
描述
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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.
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Observational assessment including telephone interviews, validated questionnaires, and clinical evaluations aimed at assessing the prevalence, evolution, and long-term outcomes of post-acute sequelae of COVID-19 (PASC) approximately five years after SARS-CoV-2 infection.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Prevalence of Post-Acute Sequelae of COVID-19 (PASC) assessed by standardized symptom checklist.
大体时间：Approximately 60 ± 3 months after SARS-CoV-2 infection
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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.
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Approximately 60 ± 3 months after SARS-CoV-2 infection
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Severity of post-acute sequelae of COVID-19 symptoms assessed by Fatigue Short Form 7a
大体时间：Approximately 60 ± 3 months after SARS-CoV-2 infection.
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Fatigue severity will be assessed using the PROMIS Fatigue Short Form 7a, a self-administered questionnaire assessing the severity and impact of fatigue.
The score will be reported as a standardized T-score, with a mean of 50 and a standard deviation of 10.
Higher T-scores indicate greater fatigue severity.
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Approximately 60 ± 3 months after SARS-CoV-2 infection.
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Severity of post-acute sequelae of COVID-19 symptoms assessed by Modified Medical Research Council Dyspnea Scale.
大体时间：Approximately 60 ± 3 months after SARS-CoV-2 infection.
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Dyspnea severity will be assessed using the Modified Medical Research Council (mMRC) Dyspnea Scale, which evaluates the degree of breathlessness associated with physical activity.
The mMRC score ranges from 0 to 4, with higher scores indicating greater severity of dyspnea.
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Approximately 60 ± 3 months after SARS-CoV-2 infection.
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Severity of post-acute sequelae of COVID-19 symptoms assessed by Perceived Deficits Questionnaire (PDQ-20).
大体时间：Approximately 60 ± 3 months after SARS-CoV-2 infection.
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Subjective cognitive impairment will be assessed using the Perceived Deficits Questionnaire-20 (PDQ-20), a self-administered questionnaire used to assess perceived cognitive difficulties.
The total score will be reported, with higher scores indicating greater perceived cognitive impairment.
A PDQ-20 score ≥27 will be considered a predefined criterion for further cognitive assessment with the Montreal Cognitive Assessment (MoCA).
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Approximately 60 ± 3 months after SARS-CoV-2 infection.
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Severity of post-acute sequelae of COVID-19 symptoms assessed by EuroQoL 5 Dimension 5 Level questionnaire (EQ-5D-5L).
大体时间：Approximately 60 ± 3 months after SARS-CoV-2 infection.
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Health-related quality of life will be assessed using the EuroQoL 5-Dimension 5-Level (EQ-5D-5L) questionnaire.
The questionnaire assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Each dimension is rated on five levels, ranging from no problems (level 1) to severe or extreme problems (level 5).
The presence of impaired health-related quality of life will be defined as a score of ≥3 in at least one of the five dimensions.
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Approximately 60 ± 3 months after SARS-CoV-2 infection.
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Frailty, sarcopenia and nutritional status assessed by Clinical Frailty Scale.
大体时间：Approximately 60 ± 3 months after SARS-CoV-2 infection.
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Frailty will be assessed using the Clinical Frailty Scale (CFS).
Frailty will be defined as a CFS score greater than 4.
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Approximately 60 ± 3 months after SARS-CoV-2 infection.
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Frailty, sarcopenia and nutritional status assessed by Primary Care-Frailty Index.
大体时间：Approximately 60 ± 3 months after SARS-CoV-2 infection.
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Frailty will be assessed using the Primary Care-Frailty Index (PC-FI).
Frailty will be defined as a PC-FI score greater than 0.07.
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Approximately 60 ± 3 months after SARS-CoV-2 infection.
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Frailty, sarcopenia and nutritional status assessed by Frailty Phenotype Score.
大体时间：Approximately 60 ± 3 months after SARS-CoV-2 infection.
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Frailty will be assessed using the Frailty Phenotype Score (PFS).
Frailty will be defined as a PFS score greater than 2.
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Approximately 60 ± 3 months after SARS-CoV-2 infection.
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Frailty, sarcopenia and nutritional status assessed by Short Physical Performance Battery.
大体时间：Approximately 60 ± 3 months after SARS-CoV-2 infection.
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Mobility disability and physical performance will be assessed using the Short Physical Performance Battery (SPPB).
The total score ranges from 0 to 12, with higher scores indicating better physical performance.
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Approximately 60 ± 3 months after SARS-CoV-2 infection.
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Frailty, sarcopenia and nutritional status assessed by handgrip strength measurement.
大体时间：Approximately 60 ± 3 months after SARS-CoV-2 infection.
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Handgrip strength will be measured during the in-person clinical assessment as an indicator of muscle strength and for the assessment of sarcopenia risk.
Handgrip strength will be reported in kilograms (kg)
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Approximately 60 ± 3 months after SARS-CoV-2 infection.
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Frailty, sarcopenia and nutritional status assessed by Mini Nutritional Assessment.
大体时间：Approximately 60 ± 3 months after SARS-CoV-2 infection.
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Nutritional status will be assessed using the Mini Nutritional Assessment (MNA) questionnaire during the in-person clinical assessment.
The MNA score will be recorded to assess nutritional status.
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Approximately 60 ± 3 months after SARS-CoV-2 infection.
|
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Cognitive and psychiatric status assessed by Montreal Cognitive Assessment (MoCA).
大体时间：Approximately 60 ± 3 months after SARS-CoV-2 infection.
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Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA).
The total MoCA score will be recorded.
A MoCA score <26 will indicate the need for further cognitive assessment.
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Approximately 60 ± 3 months after SARS-CoV-2 infection.
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Cognitive and psychiatric status assessed by Patient Health Questionnaire (PHQ-9).
大体时间：Approximately 60 ± 3 months after SARS-CoV-2 infection.
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Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9).
The total PHQ-9 score will be recorded, with higher scores indicating greater severity of depressive symptoms.
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Approximately 60 ± 3 months after SARS-CoV-2 infection.
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Cognitive and psychiatric status assessed by Generalized Anxiety Disorder scale (GAD-7).
大体时间：Approximately 60 ± 3 months after SARS-CoV-2 infection.
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Anxiety severity will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale in participants with anxiety and/or depressive symptoms.
The questionnaire will be self-administered, and the total GAD-7 score will be recorded.
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Approximately 60 ± 3 months after SARS-CoV-2 infection.
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Healthcare utilization and costs assessed by healthcare resource utilization data and standardized questionnaires.
大体时间：Approximately 60 ± 3 months after SARS-CoV-2 infection.
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Healthcare utilization and costs will be assessed through the collection of data regarding hospitalizations, emergency department visits, specialist consultations, diagnostic tests, rehabilitation treatments, medication and supplement use, out-of-pocket healthcare expenses, caregiver support, transportation costs and potential loss of work productivity
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Approximately 60 ± 3 months after SARS-CoV-2 infection.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Vincenzo Galluzzo, MD、Fondazione Policlinico Universitario Agostino Gemelli IRCCS
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2029年9月1日
研究完成 (估计的)
2029年12月31日
研究注册日期
首次提交
2026年7月29日
首先提交符合 QC 标准的
2026年8月11日
首次发布 (实际的)
2026年8月14日
研究记录更新
最后更新发布 (实际的)
2026年8月14日
上次提交的符合 QC 标准的更新
2026年8月11日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.