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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 oppdatert 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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Forventet)

3500

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
The main outcome of the study is hospital mortality
Tidsramme: 25/05/2021
25/05/2021

Sekundære resultatmål

Resultatmål
Tidsramme
Length of hospital stay
Tidsramme: 25/05/2021
25/05/2021

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Evandro Chagas National Institute of Infectious Disease

Samarbeidspartnere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

25. juli 2020

Primær fullføring (Forventet)

25. oktober 2021

Studiet fullført (Forventet)

25. mars 2022

Datoer for studieregistrering

Først innsendt

18. mars 2021

Først innsendt som oppfylte QC-kriteriene

18. mars 2021

Først lagt ut (Faktiske)

19. mars 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. mars 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. mars 2021

Sist bekreftet

1. mars 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 32449420.4.1001.5262

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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