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

Recruiting

• Conditions: Sequelae of; Infection; Covid19; SARS CoV 2 Infection

• Registration Number: NCT05046769
• Lead Sponsor: Instituto de Saude Publica da Universidade do Porto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-28
• Status Verified: 2021-09
• Study First Submitted: 2021-09-05
• Study First Submitted QC: 2021-09-13
• Last Update Submitted: 2021-09-13
• Study First Posted: 2021-09-16
• Last Update Posted: 2021-09-16
• Primary Completion: 2023-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical, biological, psychosocial characteristics	24 months	Describe the clinical, biological and psychosocial characteristics SARS-CoV-2 infected inpatients or outpatients identified in our hospital center

Secondary Outcome Measures

Name	Time	Method
Prognostic factors of course of disease	24 months	Identify clinical, biological and social associated with course of disease
Reinfection rate	24 months	Number and characteristics of reinfections
Genome sequence of SARS-CoV-2	24 months	Identify variants of SARS-CoV-2
Household contacts infection attack rate	3 months	Characterize the dynamics of infection

Trial Locations

Locations (1)

Centro Hospitalar De São João; 🇵🇹 Porto, Portugal