COVID-19, Long COVID, Post-Acute COVID-19, Post-Acute COVID-19 Infection, Post-Acute COVID-19 Syndrome
Conditions
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.
Interventions
OTHERPost-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.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Post-Acute Sequelae of COVID-19 (PASC) assessed by standardized symptom checklist. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of post-acute sequelae of COVID-19 symptoms assessed by Fatigue Short Form 7a | Approximately 60 ± 3 months after SARS-CoV-2 infection. | 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. |
| 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. | 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. |
| 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. | 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). |
| 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. | 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. |
| Frailty, sarcopenia and nutritional status assessed by Clinical Frailty Scale. | Approximately 60 ± 3 months after SARS-CoV-2 infection. | Frailty will be assessed using the Clinical Frailty Scale (CFS). Frailty will be defined as a CFS score greater than 4. |
| Frailty, sarcopenia and nutritional status assessed by Primary Care-Frailty Index. | Approximately 60 ± 3 months after SARS-CoV-2 infection. | 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. |
| Frailty, sarcopenia and nutritional status assessed by Frailty Phenotype Score. | Approximately 60 ± 3 months after SARS-CoV-2 infection. | Frailty will be assessed using the Frailty Phenotype Score (PFS). Frailty will be defined as a PFS score greater than 2. |
| Frailty, sarcopenia and nutritional status assessed by Short Physical Performance Battery. | Approximately 60 ± 3 months after SARS-CoV-2 infection. | 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. |
| Frailty, sarcopenia and nutritional status assessed by handgrip strength measurement. | Approximately 60 ± 3 months after SARS-CoV-2 infection. | 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) |
| Frailty, sarcopenia and nutritional status assessed by Mini Nutritional Assessment. | Approximately 60 ± 3 months after SARS-CoV-2 infection. | 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. |
| Cognitive and psychiatric status assessed by Montreal Cognitive Assessment (MoCA). | Approximately 60 ± 3 months after SARS-CoV-2 infection. | 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. |
| Cognitive and psychiatric status assessed by Patient Health Questionnaire (PHQ-9). | Approximately 60 ± 3 months after SARS-CoV-2 infection. | 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. |
| Cognitive and psychiatric status assessed by Generalized Anxiety Disorder scale (GAD-7). | Approximately 60 ± 3 months after SARS-CoV-2 infection. | 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. |
| Healthcare utilization and costs assessed by healthcare resource utilization data and standardized questionnaires. | Approximately 60 ± 3 months after SARS-CoV-2 infection. | 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 |
Contacts
CONTACTVincenzo Galluzzo, MD
PRINCIPAL_INVESTIGATORVincenzo Galluzzo, MD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Outcome results
None listed