An observational study in Long COVID, COVID-19 and Post-Acute COVID-19 Syndrome, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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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.
605 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 201 are open to participants now.
This study's planned enrollment of 900 is above the median of 150 across 173 observational studies indexed under Post-Acute COVID-19 Syndrome.
Browse Post-Acute COVID-19 Syndrome studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
Time frame: Approximately 60 ± 3 months after SARS-CoV-2 infection
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.
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.
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.
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).
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).
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).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Approximately 60 ± 3 months after SARS-CoV-2 infection.
No study locations are listed for this record.
Start is estimated for Sep 2026; primary completion for Sep 2029, 36 months later.
Of 98 non-industry observational studies under Post-Acute COVID-19 Syndrome, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 39. This study's planned 36 months is above that.
Counting every sponsor, half of 105 studies reached it within 27 months; a quarter within 14 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Post-Acute COVID-19 Syndrome →
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