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

Completed

• Conditions: Covid19; SARS-CoV Infection
• Interventions: Other: Non-hospitalization procedures; Other: Hospital admission

• Registration Number: NCT04479488
• Lead Sponsor: Hospital Israelita Albert Einstein

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.

Study Timeline

• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-20
• Study First Posted: 2020-07-21
• Study Start: 2020-07-27
• Primary Completion: 2021-03-30
• Status Verified: 2022-12
• Study Completion: 2022-12-30
• Last Update Submitted: 2023-03-08
• Last Update Posted: 2023-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1587

Inclusion Criteria

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

Exclusion Criteria

• Patient who expressed opposition to participation in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-hospitalized patients	Non-hospitalization procedures	Patient who are suspected or confirmed SARS-CoV2 infection non-hospitalized.
Hospitalized patients	Hospital admission	Patient who are suspected or confirmed SARS-CoV2 infection need hospitalization.

Primary Outcome Measures

Name	Time	Method
All-cause mortality	60 Days	All-cause mortality rates at 60 days

Secondary Outcome Measures

Name	Time	Method
Hospitalizations	60 Days	Rate of patients requiring hospitalization and re-hospitalization (readmission to the hospital occurring within 60 days after admission)
Intensive care unit length of stay	60 Days	ICU length of stay
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
Oxygen supplementation	60 Days	Rate of patients requiring oxygen therapy
Use of invasive mechanical ventilation	60 Days	Rate of patients requiring invasive mechanical ventilation

Trial Locations

Locations (14)

Hospital Estadual Jayme dos Santos Neves; 🇧🇷 Serra, Espirito Santo, Brazil

Hospital Santa Rita de Cássia; 🇧🇷 Vitória, Espirito Santo, Brazil

Fundação Educacional Lucas Machado; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil

Hospital de Emergencia Dr. Daniel Houly; 🇧🇷 Arapiraca, Alagoas, Brazil

Universidade Federal da Bahia; 🇧🇷 Vitória Da Conquista, Bahia, Brazil

Alencar Serviços Médicos Ltda; 🇧🇷 Barbalha, Ceará, Brazil

Fundação Hopitalar São Francisco de Assis; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil

Hospital Municipal Vila Santa Catarina; 🇧🇷 São Paulo, Brazil

Hospital São Camilo - Pompéia; 🇧🇷 São Paulo, Brazil

Hospital São Camilo - Ipiranga; 🇧🇷 São Paulo, Brazil

Hospital São Vicente de Paulo; 🇧🇷 Passo Fundo, Rio Grande Do Sul, Brazil

Santa Casa de Votuporanga; 🇧🇷 Votuporanga, São Paulo, Brazil

Hospital Santa Lucia; 🇧🇷 Poços De Caldas, Minas Gerais, Brazil

Hospital Giselda Trigueiro; 🇧🇷 Natal, Rio Grande Do Norte, Brazil