Collaborative Network for Generating Scientific Evidence in COVID-19 For the Unified Health System in Brazil - RECOVER SUS-BRASIL

NCT04807699 | Unknown

• 1 other identifier: 32449420.4.1001.5262
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 13

Brief Summary

The RECOVER SUS-BRASIL network, made up of excellent academic and research institutions, was formed in response to the emergence of unprecedented public health related to SARS-CoV-2. The Network's objectives are the production of scientific knowledge, the technical and scientific strengthening of participating centers, the sharing of information and experiences with other assistance services and the generation of evidence for public health policies in Brazil. The present proposal aims to increase the magnitude of the Network, proposing two studies to assess the epidemic of COVID-19 in Brazil. The first study deals with the establishment of a prospective cohort of patients hospitalized for COVID-19. Through using standardized data collection procedures, biological samples and biomarkers, this study will be able to describe clinical presentation, severity, risk factors for worsening of the disease. Multiple clinical outcomes of severity of disease, organ dysfunction, hospital mortality, length of hospital stay, hospital readmission and early post-discharge death. Will be biomarkers of inflammation, cellular and humoral immunity were also evaluated to study their association with clinical outcomes, variability of SARS-CoV-2 and the development of immunity in infected individuals through the detection and titration of neutralizing antibodies anti-SARS-CoV-2. The second study 2 will evaluate the COVID-19 epidemic in people living with HIV / AIDS, using SUS databases, such as SIM, SICLOM and SISCEL. This study is particularly relevant since on the one hand it includes a population potentially at greater risk of developing severe forms of the disease, given their underlying condition, as, on the other hand, they are exposed chronically to drugs that could potentially have an effect on SARS-CoV-2. Finally, a major objective of RECOVER SUS-BRASIL is integrate technical and scientific capacities generating scientific production of high relevance and impact and strengthening health and science throughout the country.

Conditions

Covid19; Hospitalization

Keywords

Covid-19; hospitalization; biomarkers

Outcome Measures

Primary Outcomes (1)

• The main outcome of the study is hospital mortality

  25/05/2021

Secondary Outcomes (1)

• Length of hospital stay

  25/05/2021

Study Arms (1)

Total participants

3500 participants that will have their medical forms checked

Other: Data collection

Interventions

Data collection OTHER

Clinical and sociodemographic data collected through interview at admission and results of complementary tests performed during hospitalization.

Total participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults aged 18 years. Hospitalized for suspicious signs and symptoms of COVID-19 infection by the medical care team or confirmed by laboratory tests such as RT-PCR or rapid tests.

Sponsors & Collaborators

• Evandro Chagas National Institute of Infectious Disease: lead
• Hospital Universitario Pedro Ernesto: collaborator
• Universidade Federal do Rio de Janeiro: collaborator
• Hospital Couto Maia/SES/BA: collaborator
• Hospital São José de Doenças Infecciosas - HSJ / Secretaria de Saúde Fortaleza: collaborator
• Hospital Estadual Sumaré Dr. Leandro Francheschini: collaborator
• Universidade Federal de Santa Maria: collaborator
• Hospital Regional de São José - Dr. Homero de Miranda Gomes: collaborator
• Hospital dos Servidores do Estado do Rio de Janeiro: collaborator
• Federal University of Minas Gerais: collaborator
• Gaffree & Guinle Universitary Hospital: collaborator
• Hospital Nossa Senhora da Conceicao: collaborator
• Instituto de Infectologia Emílio Ribas: collaborator

Study Sites (13)

Hospital São José de Doenças Infecciosas - HSJ / Secretaria de Saúde Fortaleza

Fortaleza, Ceará, 60455-610, Brazil

Location

Hospital Couto Maia/SES/BA

Salvador, Estado de Bahia, 41332-150, Brazil

Location

Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, 31270-901, Brazil

Location

Hospital dos Servidores do Estado/RJ

Rio de Janeiro, Rio de Janeiro, 20221-161, Brazil

Location

Hospital Universitário Gaffree e Guinle/HUGG/UNIRIO

Rio de Janeiro, Rio de Janeiro, 20270-004, Brazil

Location

Hospital Universitário Pedro Ernesto/UERJ

Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil

Location

Instituto Nacional de Infectologia Evandro Chagas (Fiocruz)

Rio de Janeiro, Rio de Janeiro, 21040-360, Brazil

Location

Universidade Federal do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 21941-617, Brazil

Location

Hospital Nossa Senhora da Conceição

Porto Alegre, Rio Grande do Sul, Brazil

Location

Universidade Federal de Santa Maria/ Pró-Reitoria de PósGraduação e Pesquisa

Santa Maria, Rio Grande do Sul, 97105-900, Brazil

Location

Hospital Regional de São José

São José, Santa Catarina, 88103-310, Brazil

Location

Hospital Estadual Sumaré Dr. Leandro Francheschini

Sumaré, São Paulo, 13174-530, Brazil

Location

Instituto de Infectologia Emílio Ribas

São Paulo, 01246-900, Brazil

Location

MeSH Terms

Conditions

COVID-19

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Beatriz Grinsztejn, MD, PhD

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 19, 2021
• Study Start: July 25, 2020
• Primary Completion: October 25, 2021
• Study Completion: March 25, 2022
• Last Updated: March 19, 2021

Record last verified: 2021-03

Locations

BR (13)