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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.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

観察的

入学 (推定)

900

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
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.
他の：Post-Acute Sequelae of COVID-19 (PASC) Assessment
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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Prevalence of Post-Acute Sequelae of COVID-19 (PASC) assessed by standardized symptom checklist.
時間枠：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.
Approximately 60 ± 3 months after SARS-CoV-2 infection

二次結果の測定

結果測定
メジャーの説明
時間枠
Severity of post-acute sequelae of COVID-19 symptoms assessed by Fatigue Short Form 7a
時間枠：Approximately 60 ± 3 months after SARS-CoV-2 infection.
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.
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.
時間枠：Approximately 60 ± 3 months after SARS-CoV-2 infection.
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.
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).
時間枠：Approximately 60 ± 3 months after SARS-CoV-2 infection.
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).
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).
時間枠：Approximately 60 ± 3 months after SARS-CoV-2 infection.
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.
Approximately 60 ± 3 months after SARS-CoV-2 infection.
Frailty, sarcopenia and nutritional status assessed by Clinical Frailty Scale.
時間枠：Approximately 60 ± 3 months after SARS-CoV-2 infection.
Frailty will be assessed using the Clinical Frailty Scale (CFS). Frailty will be defined as a CFS score greater than 4.
Approximately 60 ± 3 months after SARS-CoV-2 infection.
Frailty, sarcopenia and nutritional status assessed by Primary Care-Frailty Index.
時間枠：Approximately 60 ± 3 months after SARS-CoV-2 infection.
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.
Approximately 60 ± 3 months after SARS-CoV-2 infection.
Frailty, sarcopenia and nutritional status assessed by Frailty Phenotype Score.
時間枠：Approximately 60 ± 3 months after SARS-CoV-2 infection.
Frailty will be assessed using the Frailty Phenotype Score (PFS). Frailty will be defined as a PFS score greater than 2.
Approximately 60 ± 3 months after SARS-CoV-2 infection.
Frailty, sarcopenia and nutritional status assessed by Short Physical Performance Battery.
時間枠：Approximately 60 ± 3 months after SARS-CoV-2 infection.
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.
Approximately 60 ± 3 months after SARS-CoV-2 infection.
Frailty, sarcopenia and nutritional status assessed by handgrip strength measurement.
時間枠：Approximately 60 ± 3 months after SARS-CoV-2 infection.
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)
Approximately 60 ± 3 months after SARS-CoV-2 infection.
Frailty, sarcopenia and nutritional status assessed by Mini Nutritional Assessment.
時間枠：Approximately 60 ± 3 months after SARS-CoV-2 infection.
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.
Approximately 60 ± 3 months after SARS-CoV-2 infection.
Cognitive and psychiatric status assessed by Montreal Cognitive Assessment (MoCA).
時間枠：Approximately 60 ± 3 months after SARS-CoV-2 infection.
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.
Approximately 60 ± 3 months after SARS-CoV-2 infection.
Cognitive and psychiatric status assessed by Patient Health Questionnaire (PHQ-9).
時間枠：Approximately 60 ± 3 months after SARS-CoV-2 infection.
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.
Approximately 60 ± 3 months after SARS-CoV-2 infection.
Cognitive and psychiatric status assessed by Generalized Anxiety Disorder scale (GAD-7).
時間枠：Approximately 60 ± 3 months after SARS-CoV-2 infection.
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.
Approximately 60 ± 3 months after SARS-CoV-2 infection.
Healthcare utilization and costs assessed by healthcare resource utilization data and standardized questionnaires.
時間枠：Approximately 60 ± 3 months after SARS-CoV-2 infection.
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
Approximately 60 ± 3 months after SARS-CoV-2 infection.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

捜査官

  • 主任研究者：Vincenzo Galluzzo, MD、Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2029年9月1日

研究の完了 (推定)

2029年12月31日

試験登録日

最初に提出

2026年7月29日

QC基準を満たした最初の提出物

2026年8月11日

最初の投稿 (実際)

2026年8月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月14日

QC基準を満たした最後の更新が送信されました

2026年8月11日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 27636

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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