Clinical trial NCT04479488: Brazilian Registry for Clinical Presentation of Individuals With COVID-19 (SARS-Brazil)
Official title: Brazilian COVID-19 Registry for Clinical Presentation of Individuals With COVID-19: a National, Multicentre, Prospective Observational Study (SARS-Brazil)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
SARS-CoV Infection
Keywords: COVID-19
SARS-CoV2 infection
Intensive care unit
Oxygen supplementation
Invasive ventilation
Mortality
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
First posted: 2020-07-21
Enrollment: 1587
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: SARS-Brazil Registry is designed as multicenter observational cohort of adult patients (≥18 years old), that are confirmed or suspected SARS-CoV-2 infection in Brazilian hospitals.

Brief summary: This is a registry-based cohort study of all adult patients (≥18 years) with confirmed or suspected SARS-CoV-2 infection.

The main goal is to describe mortality incidence, demographic characteristics, coexisting conditions, treatments, outcomes among SARS-CoV2 infected patients.

A secondary goal is to identify biological factors (OMICS - genomic, proteomic and metabolomics characterization) associated with severity conditions for these patients.

Detailed description: Registry on characteristics and outcomes of hospitalized and non-hospitalized SARS-CoV2 infected patients in Brazil.

Eligibility criteria: Inclusion Criteria:

* Adult patients (≥18 years);
* Confirmed or suspected SARS-CoV2 infection

Exclusion Criteria:

* Patient who expressed opposition to participation in the study

Primary outcomes:
measure: All-cause mortality
timeFrame: 60 Days
Secondary outcomes:
measure: Incidence and course of symptoms of COVID-19 infection
timeFrame: 60 Days
measure: Hospitalizations
timeFrame: 60 Days
measure: Oxygen supplementation
timeFrame: 60 Days
measure: Use of invasive mechanical ventilation
timeFrame: 60 Days
measure: Intensive care unit length of stay
timeFrame: 60 Days
Other outcomes:
measure: Serum proteomic
timeFrame: 60 Days
measure: Serum metabolomic
timeFrame: 60 Days
measure: Genomic description
timeFrame: 60 Days
Locations:
city: Arapiraca
country: Brazil
facility: Hospital de Emergencia Dr. Daniel Houly
state: Alagoas
city: Vitória Da Conquista
country: Brazil
facility: Universidade Federal da Bahia
state: Bahia
city: Barbalha
country: Brazil
facility: Alencar Serviços Médicos Ltda
state: Ceará
city: Serra
country: Brazil
facility: Hospital Estadual Jayme dos Santos Neves
state: Espirito Santo
city: Vitória
country: Brazil
facility: Hospital Santa Rita de Cássia
state: Espirito Santo
city: Belo Horizonte
country: Brazil
facility: Fundação Educacional Lucas Machado
state: Minas Gerais
city: Belo Horizonte
country: Brazil
facility: Fundação Hopitalar São Francisco de Assis
state: Minas Gerais
city: Poços De Caldas
country: Brazil
facility: Hospital Santa Lucia
state: Minas Gerais
city: Natal
country: Brazil
facility: Hospital Giselda Trigueiro
state: Rio Grande Do Norte
city: Passo Fundo
country: Brazil
facility: Hospital São Vicente de Paulo
state: Rio Grande Do Sul
city: Votuporanga
country: Brazil
facility: Santa Casa de Votuporanga
state: São Paulo
city: São Paulo
country: Brazil
facility: Hospital Municipal Vila Santa Catarina
city: São Paulo
country: Brazil
facility: Hospital São Camilo - Ipiranga
city: São Paulo
country: Brazil
facility: Hospital São Camilo - Pompéia
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Otávio Berwanger, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Israelita Albert Einstein
name: Henrique A Fonseca, PhD
role: PRINCIPAL_INVESTIGATOR
References: