NCT04479488

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,587

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

July 27, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

March 9, 2023

Status Verified

December 1, 2022

Enrollment Period

8 months

First QC Date

July 13, 2020

Last Update Submit

March 8, 2023

Conditions

Keywords

COVID-19SARS-CoV2 infectionIntensive care unitOxygen supplementationInvasive ventilationMortality

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    All-cause mortality rates at 60 days

    60 Days

Secondary Outcomes (5)

  • Incidence and course of symptoms of COVID-19 infection

    60 Days

  • Hospitalizations

    60 Days

  • Oxygen supplementation

    60 Days

  • Use of invasive mechanical ventilation

    60 Days

  • Intensive care unit length of stay

    60 Days

Other Outcomes (3)

  • Serum proteomic

    60 Days

  • Serum metabolomic

    60 Days

  • Genomic description

    60 Days

Study Arms (2)

Hospitalized patients

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

Other: Hospital admission

Non-hospitalized patients

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

Other: Non-hospitalization procedures

Interventions

Usual care.

Hospitalized patients

Usual care.

Non-hospitalized patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Patient who expressed opposition to participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Hospital de Emergencia Dr. Daniel Houly

Arapiraca, Alagoas, Brazil

Location

Alencar Serviços Médicos Ltda

Barbalha, Ceará, Brazil

Location

Hospital Estadual Jayme dos Santos Neves

Serra, Espírito Santo, Brazil

Location

Hospital Santa Rita de Cássia

Vitória, Espírito Santo, Brazil

Location

Universidade Federal da Bahia

Vitória da Conquista, Estado de Bahia, Brazil

Location

Fundação Educacional Lucas Machado

Belo Horizonte, Minas Gerais, Brazil

Location

Fundação Hopitalar São Francisco de Assis

Belo Horizonte, Minas Gerais, Brazil

Location

Hospital Santa Lucia

Poços de Caldas, Minas Gerais, Brazil

Location

Hospital Giselda Trigueiro

Natal, Rio Grande do Norte, Brazil

Location

Hospital São Vicente de Paulo

Passo Fundo, Rio Grande do Sul, Brazil

Location

Santa Casa de Votuporanga

Votuporanga, São Paulo, Brazil

Location

Hospital Municipal Vila Santa Catarina

São Paulo, Brazil

Location

Hospital São Camilo - Ipiranga

São Paulo, Brazil

Location

Hospital São Camilo - Pompéia

São Paulo, Brazil

Location

Related Publications (1)

  • Fonseca HAR, Pereira AJ, Nawa RK, Sant'Anna VAR, Almeida TF, Guimaraes HP, Tognon AP, Marques LM, Silva LSCD, Bittencourt RS, Gomes CP, Martins PA, Oliveira AL, Milan EP, Dall'Orto FTC, Hoffman Filho CR, Almeida G, Hohmann FB, Moia DDF, Piano LPA, Machado FP, Soares RVP, Damiani LP, Assis SRL, Amaro Junior E, Rizzo LV, Berwanger O. Mortality, hospitalizations, and persistence of symptoms in the outpatient setting of the first COVID-19 wave in Brazil: results of SARS-Brazil cohort study. Einstein (Sao Paulo). 2024 Aug 9;22:eAO0652. doi: 10.31744/einstein_journal/2024AO0652. eCollection 2024.

Biospecimen

Retention: SAMPLES WITH DNA

Blood, serum, plasma and nasal swab

MeSH Terms

Conditions

COVID-19Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Otávio Berwanger, PhD

    Hospital Israelita Albert Einstein

    STUDY DIRECTOR
  • Henrique A Fonseca, PhD

    Hospital Israelita Albert Einstein

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2020

First Posted

July 21, 2020

Study Start

July 27, 2020

Primary Completion

March 30, 2021

Study Completion

December 30, 2022

Last Updated

March 9, 2023

Record last verified: 2022-12

Locations