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RecruitingNCT05359159Updated Dec 5, 2023

Follow-up of Patients With Previous SARS-CoV-2 Infection: Long-term Damage Assessment

An observational study in COVID-19, sponsored by University of L'Aquila. Recruiting at 2 sites in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-05.

Sponsored by University of L'Aquila · Observational

From the registry’s dates

  • Started Feb 2021; still recruiting 5 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

People affected by SARS-CoV-2 infection, whether patients have developed mild forms or a severe form of the disease, complain of nonspecific and entirely new symptoms or complain about the persistence pf them.Investigators intend to follow over time the post-infectious phase of patients discharged from sub-intensive care unit. The aim is to identify symptoms and their frequency of presentation in the SARS-CoV-2 population in the post-acute period.

02

Conditions studied

  • COVID-19

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Keywords

  • Long-COVID
  • post-COVID
  • SarS-CoV2
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 100 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

University of L'Aquila is the lead sponsor of 45 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients admitted to Ospedale San Salvatore dell'Aquila over 18 years during Sars-CoV2 pandemics, with or without Sars-CoV2 related disease

Inclusion criteria

  • Patients over 18

Exclusion criteria

Exclusion Criteria:

  • Patients under 18
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Post-COVID patients

    Patients recovered from Sars-CoV2 infection

    Other: Data collection

  • healthy control patients

    Patients who did not have Sars-CoV2

    Other: Data collection

Interventions

  • OtherData collection

    Data collection

06

What researchers measure

Primary outcomes

  1. Greater understanding of SARS-CoV-2 disease

    Greater understanding of SARS-CoV-2 disease and its long-term manifestations. To this end, the clinical manifestations, any alterations in laboratory and instrumental parameters will be evaluated to identify organ damages and calculate its prevalence

    Time frame: 24 months

Secondary outcomes

  1. Measurement of psychological impact of SARS-CoV-2 disease

    Understanding the impact of the disease and its sequelae on daily life and the impact on the psychological aspect of the person;

    Time frame: 24 months

07

Study locations

2 of 2 sites recruiting
  • Clara Balsano
    L'Aquila, Italy/L'Aquila 67100, Italy
    Recruiting
  • University of L'Aquila
    L'Aquila, 67100, Italy
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05359159
Lead sponsor
University of L'Aquila
Responsible party
Clara Balsano (Full professor, University of L'Aquila) — Principal investigator
First posted
May 3, 2022
Start date
Feb 1, 2021
Primary completion
Feb 1, 2022
Completion
Feb 2024 (estimated)
Last update
Dec 5, 2023

Study contacts

Clara Balsano
Contact
clara.balsano@univaq.it
00390862434774

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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