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

NCT ID: NCT05046769

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-28
• Study Completion Date: 2025-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Inability to obtain informed consent;

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro Hospitalar De São João, E.P.E.

OTHER

Sponsor Role: collaborator

IPATIMUP - Instituto De Patologia E Imunologia Molecular Da Universidade Do Porto

OTHER

Sponsor Role: collaborator

Instituto de Saude Publica da Universidade do Porto

OTHER

Sponsor Role: lead

Responsible Party

Margarida Fernandes Tavares

Senior researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margarida Tavares, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Centro Hospitalar Universitário São João & ISPUP

Locations

Centro Hospitalar De São João

Porto, , Portugal

Site Status: RECRUITING

Countries

Portugal

Central Contacts

Margarida Tavares, MD, MPH

Role: CONTACT

mftavares@ispup.up.pt

+351222061820

Facility Contacts

Margarida Tavares

Role: primary

margarida.tavares@chsj.min-saude.pt

+351225512389

Other Identifiers

102-20

Identifier Type: -

Identifier Source: org_study_id