COVID-19: A Scope Research on Epidemiology and Clinical Course

NCT05046769 | Unknown

• 1 other identifier: 102-20
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

Severe Acute Respiratory Syndrome (SARS) Coronavirus (CoV) 2 infection and the associated coronavirus disease 2019 (COVID-19) are the most recent international health threat challenging our ability to protect populations, to avoid severe outcomes and to understand both the population dynamics of this new condition and the breath of individual responses. Gathering information on the clinical course of the disease and the risk of transmission is essential to design effective therapeutic solutions and preventive measures. The aim of the study proposed, to be carried out at University Hospital Center of "São João" (CHUSJ), is to recruit and follow-up a cohort of patients diagnosed with SARS-CoV-2 infection, to evaluate the clinical course of SARS-CoV-2 infection and COVID-19 cases, to identify prognostic factors and to measure the risk of reinfection. Additionally, researchers intend to characterize the patients and household contacts to describe the dynamics of infection, to calculate household infection attack rate, and to perform the genetic sequencing of SARS-CoV-2 to understand determinants of disease course (namely long-term effects) and risk of household transmission. A sample of participants, identified during the process of evaluation of symptomatic individuals, at the same institution, and negative for SARS-CoV-2 will be selected as negative controls. Participants will be consecutively recruited and the study is expected to enroll patients as long as the pandemic remains. Information will be gathered based on clinical individual charts, hospital data-bases (example: for administrative data) and individual computer assisted interviews to be performed at pre-defined intervals (3, 12 and 24 months) or according to clinical needs. The project was approved by the local Ethical Committee and the Data Protection relevant authorities.

Conditions

Covid19; SARS CoV 2 Infection; Sequelae of; Infection

Keywords

Covid19; Cohort Studies; Long COVID; Secondary Attack Rate; Serology; Epidemiology

Outcome Measures

Primary Outcomes (1)

• Clinical, biological, psychosocial characteristics

  Describe the clinical, biological and psychosocial characteristics SARS-CoV-2 infected inpatients or outpatients identified in our hospital center

  24 months

Secondary Outcomes (4)

• Household contacts infection attack rate

  3 months

• Genome sequence of SARS-CoV-2

  24 months

• Reinfection rate

  24 months

• Prognostic factors of course of disease

  24 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with SARS-CoV-2 infection diagnosed at Centro Hospitalar Universitário São João, a level III hospital center, from March 1, 2020. A sample of individuals who underwent the test for diagnosis of infection by SARS-CoV-2 with negative result.

You may qualify if:

• Individuals diagnosed with SARS-2-CoV-2 infection treated at CHUSJ and cohabitants able to give informed consent;
• individuals who underwent the test for diagnosis of infection by SARS-CoV-2 at CHUSJ with negative result able to give informed consent.

You may not qualify if:

• Inability to obtain informed consent;

Sponsors & Collaborators

• Instituto de Saude Publica da Universidade do Porto: lead
• Centro Hospitalar De São João, E.P.E.: collaborator
• IPATIMUP - Instituto De Patologia E Imunologia Molecular Da Universidade Do Porto: collaborator

Study Sites (1)

Centro Hospitalar De São João

Porto, 4200-319, Portugal

RECRUITING

MeSH Terms

Conditions

COVID-19; Infections; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract 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

Study Officials

• Margarida Tavares, MD, MPH

  Centro Hospitalar Universitário São João & ISPUP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margarida Tavares, MD, MPH

CONTACT

+351222061820; mftavares@ispup.up.pt

Study Design

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

Study Record Dates

• First Submitted: September 5, 2021
• First Posted: September 16, 2021
• Study Start: April 28, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

PT (1)