Long COVIDPASC-5YNCT07766512
Five-year Follow-up After Sars-CoV-2 Infection: Prevalence and Evolution of Post-acute Sequalae of COVID-19 (PASC)
An observational study of Long COVID and COVID-19, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long COVID, COVID-19, Post-Acute COVID-19 Syndrome
- What is being tested?
- Post-Acute Sequelae of COVID-19 (PASC) Assessment
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Dec 2029
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Post-Acute Sequelae of COVID-19 (PASC) Assessment
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-Acute Sequelae of COVID-19 (PASC) AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Post-Acute Sequelae of COVID-19 (PASC) Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
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.
Measured: 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).
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).
Measured: 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).
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.
Measured: Approximately 60 ± 3 months after SARS-CoV-2 infection.
Frailty, sarcopenia and nutritional status assessed by Clinical Frailty Scale.
Frailty will be assessed using the Clinical Frailty Scale (CFS). Frailty will be defined as a CFS score greater than 4.
Measured: Approximately 60 ± 3 months after SARS-CoV-2 infection.
Frailty, sarcopenia and nutritional status assessed by Primary Care-Frailty Index.
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.
Measured: Approximately 60 ± 3 months after SARS-CoV-2 infection.
Frailty, sarcopenia and nutritional status assessed by Frailty Phenotype Score.
Frailty will be assessed using the Frailty Phenotype Score (PFS). Frailty will be defined as a PFS score greater than 2.
Measured: Approximately 60 ± 3 months after SARS-CoV-2 infection.
Frailty, sarcopenia and nutritional status assessed by Short Physical Performance Battery.
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.
Measured: Approximately 60 ± 3 months after SARS-CoV-2 infection.
Frailty, sarcopenia and nutritional status assessed by handgrip strength measurement.
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)
Measured: Approximately 60 ± 3 months after SARS-CoV-2 infection.
Frailty, sarcopenia and nutritional status assessed by Mini Nutritional Assessment.
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.
Measured: Approximately 60 ± 3 months after SARS-CoV-2 infection.
Cognitive and psychiatric status assessed by Montreal Cognitive Assessment (MoCA).
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.
Measured: Approximately 60 ± 3 months after SARS-CoV-2 infection.
Cognitive and psychiatric status assessed by Patient Health Questionnaire (PHQ-9).
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.
Measured: Approximately 60 ± 3 months after SARS-CoV-2 infection.
Cognitive and psychiatric status assessed by Generalized Anxiety Disorder scale (GAD-7).
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.
Measured: Approximately 60 ± 3 months after SARS-CoV-2 infection.
Healthcare utilization and costs assessed by healthcare resource utilization data and standardized questionnaires.
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
Measured: Approximately 60 ± 3 months after SARS-CoV-2 infection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Galluzzo Vincenzo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Vincenzo Galluzzo, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766512
- Sponsor's protocol ID
- 27636
- Acronym
- PASC-5Y
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Five-year Follow-up After Sars-CoV-2 Infection: Prevalence and Evolution of Post-acute Sequalae of COVID-19 (PASC)
- ClinicalTrials.gov ID
- NCT07766512
- Acronym / sponsor ID
- PASC-5Y / 27636
- Conditions
- Long COVID, COVID-19, Post-Acute COVID-19 Syndrome, Post-Acute COVID-19 Infection, Post-Acute COVID-19
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-COVID Cohort | – | Other: Post-Acute Sequelae of COVID-19 (PASC) AssessmentAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post-Acute Sequelae of COVID-19 (PASC) AssessmentObservational 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. | Other | Post-COVID Cohort |
Primary outcome
Prevalence of Post-Acute Sequelae of COVID-19 (PASC) assessed by standardized symptom checklist.
Time frame: 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.
14 secondary outcomes
Severity of post-acute sequelae of COVID-19 symptoms assessed by Fatigue Short Form 7a
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Approximately 60 ± 3 months after SARS-CoV-2 infection.
Frailty, sarcopenia and nutritional status assessed by Clinical Frailty Scale.
Time frame: Approximately 60 ± 3 months after SARS-CoV-2 infection.
Frailty, sarcopenia and nutritional status assessed by Primary Care-Frailty Index.
Time frame: Approximately 60 ± 3 months after SARS-CoV-2 infection.
Frailty, sarcopenia and nutritional status assessed by Frailty Phenotype Score.
Time frame: Approximately 60 ± 3 months after SARS-CoV-2 infection.
Frailty, sarcopenia and nutritional status assessed by Short Physical Performance Battery.
Time frame: Approximately 60 ± 3 months after SARS-CoV-2 infection.
Frailty, sarcopenia and nutritional status assessed by handgrip strength measurement.
Time frame: Approximately 60 ± 3 months after SARS-CoV-2 infection.
Frailty, sarcopenia and nutritional status assessed by Mini Nutritional Assessment.
Time frame: Approximately 60 ± 3 months after SARS-CoV-2 infection.
Cognitive and psychiatric status assessed by Montreal Cognitive Assessment (MoCA).
Time frame: Approximately 60 ± 3 months after SARS-CoV-2 infection.
Cognitive and psychiatric status assessed by Patient Health Questionnaire (PHQ-9).
Time frame: Approximately 60 ± 3 months after SARS-CoV-2 infection.
Cognitive and psychiatric status assessed by Generalized Anxiety Disorder scale (GAD-7).
Time frame: Approximately 60 ± 3 months after SARS-CoV-2 infection.
Healthcare utilization and costs assessed by healthcare resource utilization data and standardized questionnaires.
Time frame: Approximately 60 ± 3 months after SARS-CoV-2 infection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincenzo Galluzzo, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
An observational study of Long COVID and COVID-19, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincenzo Galluzzo, MD (+390630153890, vincenzo.galluzzo@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Post-Acute Sequelae of COVID-19 (PASC) assessed by standardized symptom checklist. (time frame: Approximately 60 ± 3 months after SARS-CoV-2 infection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.