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

NCT07766512 | Not Yet Recruiting

• 1 other identifier: 27636
• Study Type: observational
• Target: 900
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Long COVID; COVID-19; Post-Acute COVID-19 Syndrome; Post-Acute COVID-19 Infection; Post-Acute COVID-19

Outcome Measures

Primary Outcomes (1)

• Prevalence of Post-Acute Sequelae of COVID-19 (PASC) assessed by standardized symptom checklist.

  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

Secondary Outcomes (14)

• Severity of post-acute sequelae of COVID-19 symptoms assessed by Fatigue Short Form 7a

  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.

  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).

  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).

  Approximately 60 ± 3 months after SARS-CoV-2 infection.

• Frailty, sarcopenia and nutritional status assessed by Clinical Frailty Scale.

  Approximately 60 ± 3 months after SARS-CoV-2 infection.

Study Arms (1)

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.

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

Interventions

Post-Acute Sequelae of COVID-19 (PASC) Assessment OTHER

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.

Post-COVID Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Vincenzo Galluzzo, MD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincenzo Galluzzo, MD

CONTACT

+390630153890; vincenzo.galluzzo@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 14, 2026

Record last verified: 2026-08