Burden of COVID-19 Infection in Populations With High or Low Risk of Infection

NCT04636203 | Completed

• 1 other identifier: DEP_032020
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 2

Brief Summary

Introduction. Some issues remain to be elucidated about SARS-CoV-2 infection to plan prevention interventions based on scientific evidence, such as the actual prevalence of infection including subclinical and seroconverted cases, the reasons for the different spread and severity of the infection in different subjects and geographical areas as well as the impact of the COVID-19 crisis on the health of healthcare professionals and in the general population. The aims of this project are: (i) to estimate and compare the real prevalence of the SARS-CoV-2 infection and seroconversion in two populations at high or low risk of infection,in Lombardia region and Molise region, respectively; focusing on subgroups at higher risk such as healthcare workers (HCWs); (ii) to estimate the incidence of burnout and post-traumatic stress disorder in HCWs; (iii) to identify factors associated with SARS-CoV-2 infection positivity and to follow up its mid-term effects on health. Methods. Participants will be randomly selected from the general population of both territories and from the HCWs list of the two healthcare facilities involved. SARS-CoV-2 IgG and IgM blood levels will be measured and anamnestic data will be collected through computerized tools. Prevalence of currently or previously infected subjects and their disease status and severity will be estimated and the association with potential risk factors will be analyzed through multivariable regression analyses. Expected results. The study will identify the burden of the infection in the general and HCWs populations. It will also identify the determinants of differences in the spread and severity of the infection, to hypothesize new preventive or therapeutic interventions. This study will provide a basis for monitoring the progress of the infection and its medium-term health consequences, Finally it will allow planning future studies, through analyses in biological samples which will be collected in dedicated biobanks.

Conditions

SARS-CoV-2 Infection; Covid19

Keywords

SARS-CoV-2; Healthcare workers; General population

Outcome Measures

Primary Outcomes (3)

• SARS-CoV-2 infection

  To estimate and compare the real prevalence of the SARS-CoV-2 infection and seroconversion in two populations at high or low risk of infection. The knowledge of the real prevalence of currently or previously infected subjects, then the actual immunization in the general population and in HCWs, will allow to estimate the real impact of the condition and to better predict the time-course of potential new outbreaks, considering the estimated impact of the herd immunity in slowing it down

  From December 15 2020 to June 15 2021

• Burnout and post-traumatic stress disorder in HCWs

  To estimate the incidence of burnout and post-traumatic stress disorder in HCWs. To understand the impact of COVID-19 crisis on their health, also by quantifying their stress levels, and to set the priorities for intervention in this population subgroup (HCWs)

  From December 15 2020 to June 15 2021

• SARS-CoV-2 infection positivity factors/determinants

  To identify different characteristics of the subjects who have / have had the infection or the positives who have developed more serious forms will allow better understanding of the transmission pathways or the mechanism underlying the pathogenesis of the viral infection and of its manifestations, facilitating the development of new preventive or therapeutic interventions

  From December 15 2020 to December 15 2021

Secondary Outcomes (2)

• Population cohort of immunized subjects

  From December 15 2020 to June 15 2022

• Biobank biospecimen collection

  From December 15 2020 to June 15 2022

Study Arms (2)

General population

A sample of 3,000 men and women, residents in the territories of ASST Sette Laghi (Lombardia) and of Molise Region will be randomly selected from the municipal registries, and will be invited to participate.

Healthcare workers (HCWs)

All HCWs from the occupational registries of ASST Ospedale di Circolo Varese (Lombardia) and IRCCS Neuromed Pozzilli (Molise) will be invited to participate, up to reach 500 recruited subjects.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General population Residents in the territories of ASST Sette Laghi (Lombardia) and of Molise Region will be randomly selected from the municipal registries, and will be invited to participate. Healthcare workers (HCWs) All HCWs from the occupational registries of ASST Ospedale di Circolo, Varese (Lombardia) and IRCCS Neuromed, Pozzilli (Molise) will be invited to partecipate

You may qualify if:

• Signing a written consent

You may not qualify if:

• None

Sponsors & Collaborators

• Neuromed IRCCS: lead

Study Sites (2)

IRCCS INM Neuromed, Department of Epidemiology and Prevention

Pozzilli, IS, 86077, Italy

Location

ASST Settelaghi

Varese, VA, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample will be taken for testing of IgM and IgG against SARS-CoV-2 and for storage in the biobank. Laboratory analyses will be performed to assess blood cell count, CRP, glucose and insulin levels.

MeSH Terms

Conditions

COVID-19

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

Study Officials

• Licia Iacoviello, MD, PhD

  IRCCS Neuromed

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 19, 2020
• Study Start: January 15, 2020
• Primary Completion: September 15, 2022
• Study Completion: December 31, 2022
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)