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NCT Number: NCT04479488

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV Infection Severe Acute Respiratory Syndrome Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Emergencia Dr. Daniel Houly, Arapiraca, Alagoas, Brazil

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient who expressed opposition to participation in the study

Treatment and study plan

Hospital admission

Other

Usual care.

Non-hospitalization procedures

Other

Usual care.

Primary outcomes

  1. All-cause mortality

    Time frame: 60 Days

    All-cause mortality rates at 60 days

Secondary outcomes

  1. Incidence and course of symptoms of COVID-19 infection

    Time frame: 60 Days

    To assess the prevalence and course of symptoms of COVID-19 infection of patients followed during a period of 60 days

  2. Hospitalizations

    Time frame: 60 Days

    Rate of patients requiring hospitalization and re-hospitalization (readmission to the hospital occurring within 60 days after admission)

  3. Oxygen supplementation

    Time frame: 60 Days

    Rate of patients requiring oxygen therapy

  4. Use of invasive mechanical ventilation

    Time frame: 60 Days

    Rate of patients requiring invasive mechanical ventilation

  5. Intensive care unit length of stay

    Time frame: 60 Days

    ICU length of stay

Other outcomes

  1. Serum proteomic

    Time frame: 60 Days

    Percentual changes in serum proteome of patients with mild or moderate to severe disease

  2. Serum metabolomic

    Time frame: 60 Days

    Percentual changes in serum metabolome of patients with mild or moderate to severe disease

  3. Genomic description

    Time frame: 60 Days

    Determination of whole genome sequence and transcriptomic of mild or moderate to severe disease

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Collaborators

  • Ministry of Health, Brazil

Registry information

Official study title

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

Acronym: SARS-Brazil

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 21, 2020
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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