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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04807699
Acronym
Recoversus
Enrollment
3500
Registered
2021-03-19
Start date
2020-07-25
Completion date
2022-03-25
Last updated
2021-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Hospitalization

Keywords

Covid-19, hospitalization, biomarkers

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.

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.

Interventions

OTHERData collection

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

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The main outcome of the study is hospital mortality25/05/2021

Secondary

MeasureTime frame
Length of hospital stay25/05/2021

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026