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

Covid19 Clinical Trial

— COVID-Scope  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05046769
• Other study ID #: 102-20
• Status: Recruiting
• Start date: April 28, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2021
• Source: Instituto de Saude Publica da Universidade do Porto
• Contact: Margarida Tavares, MD, MPH
• Phone: +351222061820
• Email: mftavares[@]ispup.up.pt
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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;

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Covid19
• Infections
• Sequelae of; Infection

Locations

Country	Name	City	State
Portugal	Centro Hospitalar De São João	Porto

Sponsors (3)

Lead Sponsor	Collaborator
Instituto de Saude Publica da Universidade do Porto	Centro Hospitalar De São João, E.P.E., IPATIMUP - Instituto De Patologia E Imunologia Molecular Da Universidade Do Porto

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Household contacts infection attack rate	Characterize the dynamics of infection	3 months
Secondary	Genome sequence of SARS-CoV-2	Identify variants of SARS-CoV-2	24 months
Secondary	Reinfection rate	Number and characteristics of reinfections	24 months
Secondary	Prognostic factors of course of disease	Identify clinical, biological and social associated with course of disease	24 months