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

18 mars 2021 uppdaterad av: Raquel Malaguthi de Souza, Evandro Chagas National Institute of Infectious Disease

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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Förväntat)

3500

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Total participants
3500 participants that will have their medical forms checked
Övrig: Data collection
Clinical and sociodemographic data collected through interview at admission and results of complementary tests performed during hospitalization.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
The main outcome of the study is hospital mortality
Tidsram: 25/05/2021
25/05/2021

Sekundära resultatmått

Resultatmått
Tidsram
Length of hospital stay
Tidsram: 25/05/2021
25/05/2021

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Evandro Chagas National Institute of Infectious Disease

Samarbetspartners

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

25 juli 2020

Primärt slutförande (Förväntat)

25 oktober 2021

Avslutad studie (Förväntat)

25 mars 2022

Studieregistreringsdatum

Först inskickad

18 mars 2021

Först inskickad som uppfyllde QC-kriterierna

18 mars 2021

Första postat (Faktisk)

19 mars 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

19 mars 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 mars 2021

Senast verifierad

1 mars 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 32449420.4.1001.5262

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

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