Clinical trial NCT05046769: COVID-19: A Scope Research on Epidemiology and Clinical Course
Official title: COVID-19: A Scope Research on Epidemiology and Clinical Course
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Covid19
SARS CoV 2 Infection
Sequelae of; Infection
Keywords: Covid19
Cohort Studies
Long COVID
Secondary Attack Rate
Serology
Epidemiology
Lead sponsor: Instituto de Saude Publica da Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Centro Hospitalar De São João, E.P.E.
name: IPATIMUP - Instituto De Patologia E Imunologia Molecular Da Universidade Do Porto
First posted: 2021-09-16
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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;

Primary outcomes:
measure: Clinical, biological, psychosocial characteristics
timeFrame: 24 months
Secondary outcomes:
measure: Household contacts infection attack rate
timeFrame: 3 months
measure: Genome sequence of SARS-CoV-2
timeFrame: 24 months
measure: Reinfection rate
timeFrame: 24 months
measure: Prognostic factors of course of disease
timeFrame: 24 months
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Centro Hospitalar De São João
Study officials:
affiliation: Centro Hospitalar Universitário São João & ISPUP
name: Margarida Tavares, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: