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Clinical Trials/NCT05046769
NCT05046769
Recruiting
Not Applicable

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

Instituto de Saude Publica da Universidade do Porto1 site in 1 country5,000 target enrollmentApril 28, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
Instituto de Saude Publica da Universidade do Porto
Enrollment
5000
Locations
1
Primary Endpoint
Clinical, biological, psychosocial characteristics
Status
Recruiting
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 28, 2020
End Date
December 31, 2025
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Instituto de Saude Publica da Universidade do Porto
Responsible Party
Principal Investigator
Principal Investigator

Margarida Fernandes Tavares

Senior researcher

Instituto de Saude Publica da Universidade do Porto

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;

Outcomes

Primary Outcomes

Clinical, biological, psychosocial characteristics

Time Frame: 24 months

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

Secondary Outcomes

  • Prognostic factors of course of disease(24 months)
  • Reinfection rate(24 months)
  • Genome sequence of SARS-CoV-2(24 months)
  • Household contacts infection attack rate(3 months)

Study Sites (1)

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