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

NCT05359159 | Unknown

• 1 other identifier: 66848
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

COVID-19

Keywords

Long-COVID; post-COVID; SarS-CoV2

Outcome Measures

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

  24 months

Secondary Outcomes (1)

• Measurement of psychological impact of SARS-CoV-2 disease

  24 months

Study Arms (2)

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

Data collection OTHER

Data collection

Post-COVID patients; healthy control patients

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients over 18

You may not qualify if:

• Patients under 18

Sponsors & Collaborators

• University of L'Aquila: lead

Study Sites (2)

Clara Balsano

L’Aquila, Italy/L'Aquila, 67100, Italy

RECRUITING

University of L'Aquila

L’Aquila, 67100, Italy

RECRUITING

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Clara Balsano

CONTACT

00390862434774; clara.balsano@univaq.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 3, 2022
• Study Start: February 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2024
• Last Updated: December 5, 2023

Record last verified: 2023-11

Locations

IT (2)