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

Rede Colaborativa Para Geração de Evidência Científica em COVID-19 Para o Sistema Único de Saúde no Brasil - RECOVER SUS-BRASIL

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.

Study Overview

• Status: Unknown
• Conditions: Covid19; Hospitalization
• Intervention / Treatment: Other: Data collection

Detailed Description

Study 1 procedures are clinical and sociodemographic data collected through interview at admission and results of complementary exams performed during hospitalization. Data will be collected during the participant's inclusion visit (Day 0,equivalent to the date of hospital admission) and subsequently according to in-hospital visits untill discharge moment.

The team of researchers will have access to the electronic medical record or, as the case, to the paper medical record for the collection of data and variables of the study interest, and questionnaires with specific questions from participants or family members.

A visit in 31-60 days will be made, by telephone contact, for the application by a health professional of a questionnaire on mental health and verification of the occurrence of death or hospital readmission. The mental health questionnaire includes tracking disorders, such as: depression, anxiety, post-traumatic stress disorder, suicidal ideation and insomnia [questionnaires PHQ-9, GAD-7, Abbreviated PCL-C and Index Severity of Insomnia], in addition to a questionnaire on social support [MSPSS]. Patients identified with health disorders over the telephone will be referred to specialized care by a psychiatrist. Study 2 - Data from information systems drug dispensation (SICLOM - http://www.aids.gov.br/pt-br/gestores/sistemas-de-informacao/sistema-de-controle-logistico-demedicamentos-siclom), laboratory tests (SISCEL - http : //www.aids.gov.br/pt-br/sistema-de-informacao/sistema-de-controle-de-exameslaboratoriais-da-rede-nacional-de-contagem-de), information on mortality (SIM - http://sim.saude.gov.br/) and COVID-19 case notification database will be released to the Ministry of Health, with data identified with patient name, mother's name and date of birth to enable the linkage process. This sensitive data is obtained through specific forms, which include confidentiality clauses of the data. All transport and storage of this data, whether by digital physical means (for example, CD) or via the web, will be done in encrypted form with a strong algorithm. The final database will be de-identified to guarantee the confidentiality of the participants.

• Study Type: Observational
• Enrollment (Anticipated): 3500

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01246-900
    • Instituto de Infectologia Emilio Ribas
  • Bahia
    • Salvador, Bahia, Brazil, 41332-150
      • Hospital Couto Maia/SES/BA
  • Ceará
    • Fortaleza, Ceará, Brazil, 60455-610
      • Hospital São José de Doenças Infecciosas - HSJ / Secretaria de Saúde Fortaleza
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 31270-901
      • Universidade Federal de Minas Gerais
  • RJ
    • Rio de Janeiro, RJ, Brazil, 21040-360
      • Instituto Nacional de Infectologia Evandro Chagas (Fiocruz)
    • Rio de Janeiro, RJ, Brazil, 20221-161
      • Hospital dos Servidores do Estado/RJ
    • Rio de Janeiro, RJ, Brazil, 20270-004
      • Hospital Universitário Gaffree e Guinle/HUGG/UNIRIO
    • Rio de Janeiro, RJ, Brazil, 20551-030
      • Hospital Universitário Pedro Ernesto/UERJ
    • Rio de Janeiro, RJ, Brazil, 21941-617
      • Universidade Federal do Rio de Janeiro
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Hospital Nossa Senhora Da Conceicao
    • Santa Maria, Rio Grande Do Sul, Brazil, 97105-900
      • Universidade Federal de Santa Maria/ Pró-Reitoria de PósGraduação e Pesquisa
  • Santa Catarina
    • São José, Santa Catarina, Brazil, 88103-310
      • Hospital Regional de São José
  • São Paulo
    • Sumaré, São Paulo, Brazil, 13174-530
      • Hospital Estadual Sumaré Dr. Leandro Francheschini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria: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.

Exclusion Criteria:Patient or family member refusal

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Total participants; 3500 participants that will have their medical forms checked	Other: Data collection; Clinical and sociodemographic data collected through interview at admission and results of complementary tests performed during hospitalization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The main outcome of the study is hospital mortality	25/05/2021

Secondary Outcome Measures

Outcome Measure	Time Frame
Length of hospital stay	25/05/2021

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2020
• Primary Completion (Anticipated): October 25, 2021
• Study Completion (Anticipated): March 25, 2022

Study Registration Dates

• First Submitted: March 18, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: biomarkers; Covid-19; hospitalization
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 32449420.4.1001.5262

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No