Brazilian Registry for Clinical Presentation of Individuals With COVID-19 (SARS-Brazil)

Sponsor

Hospital Israelita Albert Einstein (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04479488

Collaborator

Ministry of Health, Brazil (Other)

1,587

Enrollment

Locations

33.1

Anticipated Duration (Months)

113.4

Patients Per Site

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 SARS-CoV Infection	Other: Hospital admission Other: Non-hospitalization procedures

Detailed Description

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

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

1587 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Brazilian COVID-19 Registry for Clinical Presentation of Individuals With COVID-19: a National, Multicentre, Prospective Observational Study (SARS-Brazil)

Actual Study Start Date :

Jul 27, 2020

Actual Primary Completion Date :

Mar 30, 2021

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Hospitalized patients Patient who are suspected or confirmed SARS-CoV2 infection need hospitalization.	Other: Hospital admission Usual care.
Non-hospitalized patients Patient who are suspected or confirmed SARS-CoV2 infection non-hospitalized.	Other: Non-hospitalization procedures Usual care.

Arm

Intervention/Treatment

Hospitalized patients

Patient who are suspected or confirmed SARS-CoV2 infection need hospitalization.

Other: Hospital admission

Usual care.

Non-hospitalized patients

Patient who are suspected or confirmed SARS-CoV2 infection non-hospitalized.

Other: Non-hospitalization procedures

Usual care.

Outcome Measures

Primary Outcome Measures

All-cause mortality [60 Days]
All-cause mortality rates at 60 days

Secondary Outcome Measures

Incidence and course of symptoms of COVID-19 infection [60 Days]
To assess the prevalence and course of symptoms of COVID-19 infection of patients followed during a period of 60 days
Hospitalizations [60 Days]
Rate of patients requiring hospitalization and re-hospitalization (readmission to the hospital occurring within 60 days after admission)
Oxygen supplementation [60 Days]
Rate of patients requiring oxygen therapy
Use of invasive mechanical ventilation [60 Days]
Rate of patients requiring invasive mechanical ventilation
Intensive care unit length of stay [60 Days]
ICU length of stay

Other Outcome Measures

Serum proteomic [60 Days]
Percentual changes in serum proteome of patients with mild or moderate to severe disease
Serum metabolomic [60 Days]
Percentual changes in serum metabolome of patients with mild or moderate to severe disease
Genomic description [60 Days]
Determination of whole genome sequence and transcriptomic of mild or moderate to severe disease

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Patient who expressed opposition to participation in the study

Contacts and Locations

Locations

	Site	City	State	Country
1	Hospital de Emergencia Dr. Daniel Houly	Arapiraca	Alagoas	Brazil
2	Universidade Federal da Bahia	Vitória Da Conquista	Bahia	Brazil
3	Alencar Serviços Médicos Ltda	Barbalha	Ceará	Brazil
4	Hospital Estadual Jayme dos Santos Neves	Serra	Espirito Santo	Brazil
5	Hospital Santa Rita de Cássia	Vitória	Espirito Santo	Brazil
6	Fundação Educacional Lucas Machado	Belo Horizonte	Minas Gerais	Brazil
7	Fundação Hopitalar São Francisco de Assis	Belo Horizonte	Minas Gerais	Brazil
8	Hospital Santa Lucia	Poços De Caldas	Minas Gerais	Brazil
9	Hospital Giselda Trigueiro	Natal	Rio Grande Do Norte	Brazil
10	Hospital São Vicente de Paulo	Passo Fundo	Rio Grande Do Sul	Brazil
11	Santa Casa de Votuporanga	Votuporanga	São Paulo	Brazil
12	Hospital Municipal Vila Santa Catarina	São Paulo		Brazil
13	Hospital São Camilo - Ipiranga	São Paulo		Brazil
14	Hospital São Camilo - Pompéia	São Paulo		Brazil

Sponsors and Collaborators

Hospital Israelita Albert Einstein
Ministry of Health, Brazil

Investigators

Study Director: Otávio Berwanger, PhD, Hospital Israelita Albert Einstein
Principal Investigator: Henrique A Fonseca, PhD, Hospital Israelita Albert Einstein