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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 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Osservativo

Iscrizione (Stimato)

900

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Prevalence of Post-Acute Sequelae of COVID-19 (PASC) assessed by standardized symptom checklist.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Severity of post-acute sequelae of COVID-19 symptoms assessed by Fatigue Short Form 7a
Lasso di tempo: 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.
Lasso di tempo: 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).
Lasso di tempo: 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).
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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).
Lasso di tempo: 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).
Lasso di tempo: 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).
Lasso di tempo: 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.
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigatori

  • Investigatore principale: Vincenzo Galluzzo, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 settembre 2029

Completamento dello studio (Stimato)

31 dicembre 2029

Date di iscrizione allo studio

Primo inviato

29 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 agosto 2026

Primo Inserito (Effettivo)

14 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 27636

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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