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

Covid19 Clinical Trial

— SARS-Brazil  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04479488
• Other study ID #: 30047620.3.0000.0071
• Status: Completed
• Start date: July 27, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: December 2022
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1587
• Est. completion date: December 30, 2022
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patient who expressed opposition to participation in the study

Related Conditions & MeSH terms

• COVID-19
• Covid19
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Other:
• Hospital admission
Usual care.
• Non-hospitalization procedures
Usual care.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein	Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum proteomic	Percentual changes in serum proteome of patients with mild or moderate to severe disease	60 Days
Other	Serum metabolomic	Percentual changes in serum metabolome of patients with mild or moderate to severe disease	60 Days
Other	Genomic description	Determination of whole genome sequence and transcriptomic of mild or moderate to severe disease	60 Days
Primary	All-cause mortality	All-cause mortality rates at 60 days	60 Days
Secondary	Incidence and course of symptoms of COVID-19 infection	To assess the prevalence and course of symptoms of COVID-19 infection of patients followed during a period of 60 days	60 Days
Secondary	Hospitalizations	Rate of patients requiring hospitalization and re-hospitalization (readmission to the hospital occurring within 60 days after admission)	60 Days
Secondary	Oxygen supplementation	Rate of patients requiring oxygen therapy	60 Days
Secondary	Use of invasive mechanical ventilation	Rate of patients requiring invasive mechanical ventilation	60 Days
Secondary	Intensive care unit length of stay	ICU length of stay	60 Days