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

2021年3月18日 更新者: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.

研究概览

地位

未知

详细说明

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.

研究类型

观察性的

注册 (预期的)

3500

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

概率样本

研究人群

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.

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Total participants
3500 participants that will have their medical forms checked
Clinical and sociodemographic data collected through interview at admission and results of complementary tests performed during hospitalization.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
The main outcome of the study is hospital mortality
大体时间:25/05/2021
25/05/2021

次要结果测量

结果测量
大体时间
Length of hospital stay
大体时间:25/05/2021
25/05/2021

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年7月25日

初级完成 (预期的)

2021年10月25日

研究完成 (预期的)

2022年3月25日

研究注册日期

首次提交

2021年3月18日

首先提交符合 QC 标准的

2021年3月18日

首次发布 (实际的)

2021年3月19日

研究记录更新

最后更新发布 (实际的)

2021年3月19日

上次提交的符合 QC 标准的更新

2021年3月18日

最后验证

2021年3月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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