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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Other: Data collection

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Clara Balsano; Phone Number: 00390862434774; Email: clara.balsano@univaq.it

Study Locations

• Italy
  • L'Aquila, Italy, 67100
    • Recruiting
    • University of L'Aquila
    • Contact: Clara Balsano; Phone Number: +39 0862434774; Email: clara.balsano@univaq.it
  • Italy/L'Aquila
    • L'Aquila, Italy/L'Aquila, Italy, 67100
      • Recruiting
      • Clara Balsano
      • Contact: Clara Balsano; Phone Number: +390862434774; Email: clara.balsano@univaq.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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

Description

Inclusion Criteria:

• Patients over 18

Exclusion Criteria:

• Patients under 18

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Post-COVID patients; Patients recovered from Sars-CoV2 infection	Other: Data collection; Data collection
healthy control patients; Patients who did not have Sars-CoV2	Other: Data collection; Data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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;	24 months

Collaborators and Investigators

• Sponsor: University of L'Aquila

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): February 1, 2022
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Long-COVID; post-COVID; SarS-CoV2
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 66848

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No