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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)

11 de agosto de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Observacional

Inscrição (Estimado)

900

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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.
Outro: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Prevalence of Post-Acute Sequelae of COVID-19 (PASC) assessed by standardized symptom checklist.
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Severity of post-acute sequelae of COVID-19 symptoms assessed by Fatigue Short Form 7a
Prazo: 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.
Prazo: 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).
Prazo: 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).
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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).
Prazo: 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).
Prazo: 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).
Prazo: 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.
Prazo: 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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigadores

  • Investigador principal: Vincenzo Galluzzo, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

1 de setembro de 2029

Conclusão do estudo (Estimado)

31 de dezembro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

29 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de agosto de 2026

Primeira postagem (Real)

14 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

11 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 27636

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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