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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: Margarida Tavares, MD, MPH; Phone Number: +351222061820; Email: mftavares@ispup.up.pt

Study Locations

• Portugal
  • Porto, Portugal, 4200-319
    • Recruiting
    • Centro Hospitalar de São João
    • Contact: Margarida Tavares; Phone Number: +351225512389; Email: margarida.tavares@chsj.min-saude.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Instituto de Saude Publica da Universidade do Porto
• Collaborators: IPATIMUP - Instituto De Patologia E Imunologia Molecular Da Universidade Do Porto; Centro Hospitalar De São João, E.P.E.
• Investigators: Principal Investigator: Margarida Tavares, MD, MPH, Centro Hospitalar Universitário São João & ISPUP

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: September 5, 2021
• First Submitted That Met QC Criteria: September 13, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 13, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Covid19; Epidemiology; Long COVID; Cohort Studies; Serology; Secondary Attack Rate
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Infections; Communicable Diseases
• Other Study ID Numbers: 102-20 (registry identifier)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No