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Five-year Follow-up After Sars-CoV-2 Infection: Prevalence and Evolution of Post-acute Sequalae of COVID-19 (PASC)

Not Yet RecruitingN/A

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Conditions: Long COVID, COVID-19, Post-Acute COVID-19 Syndrome, Post-Acute COVID-19 Infection, Post-Acute COVID-19

Interventions: Post-Acute Sequelae of COVID-19 (PASC) Assessment

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.