Five-year Follow-up After Sars-CoV-2 Infection: Prevalence and Evolution of Post-acute Sequalae o… (NCT07766512) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Five-year Follow-up After Sars-CoV-2 Infection: Prevalence and Evolution of Post-acute Sequalae of COVID-19 (PASC)
900 participantsStarted 2026-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prevalence of Post-Acute Sequelae of COVID-19 (PASC) assessed by standardized symptom checklist.
Timeframe: Approximately 60 ± 3 months after SARS-CoV-2 infection