Covid19RecoversusNCT04807699
Collaborative Network for Generating Scientific Evidence in COVID-19 For the Unified Health System in Brazil - RECOVER SUS-BRASIL
An observational study of Covid19 and Hospitalization, run by Evandro Chagas National Institute of Infectious Disease at 13 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Hospitalization
- What is being tested?
- Data collection
- How many people
- 3,500 participants
- Where
- 13 sitesBrazil
- Study dates
- 25 Jul 2020to 25 Mar 2022
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Brazil13 sites
Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 31270-901
Hospital São José de Doenças Infecciosas - HSJ / Secretaria de Saúde Fortaleza
Fortaleza, Ceará, 60455-610
Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul
Hospital dos Servidores do Estado/RJ
Rio de Janeiro, Rio de Janeiro, 20221-161
Hospital Universitário Gaffree e Guinle/HUGG/UNIRIO
Rio de Janeiro, Rio de Janeiro, 20270-004
Hospital Universitário Pedro Ernesto/UERJ
Rio de Janeiro, Rio de Janeiro, 20551-030
Instituto Nacional de Infectologia Evandro Chagas (Fiocruz)
Rio de Janeiro, Rio de Janeiro, 21040-360
Universidade Federal do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 21941-617
Hospital Couto Maia/SES/BA
Salvador, Estado de Bahia, 41332-150
Universidade Federal de Santa Maria/ Pró-Reitoria de PósGraduação e Pesquisa
Santa Maria, Rio Grande do Sul, 97105-900
Hospital Regional de São José
São José, Santa Catarina, 88103-310
Instituto de Infectologia Emílio Ribas
São Paulo, 01246-900
Hospital Estadual Sumaré Dr. Leandro Francheschini
Sumaré, São Paulo, 13174-530
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid19, Hospitalization
- Being tested
- Data collection
- Keywords
- Covid-19, hospitalization, biomarkers
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Clinical and sociodemographic data collected through interview at admission and results of complementary tests performed during hospitalization.
| Study group | Role | What they receive |
|---|---|---|
| Total participants | 3500 participants that will have their medical forms checked Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main outcome of the study is hospital mortality
Measured: 25/05/2021
Secondary outcomes (1)
Length of hospital stay
Measured: 25/05/2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start25 Jul 2020
- Primary completion25 Oct 2021 (estimated)
- Study completion25 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,500 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Evandro Chagas National Institute of Infectious Disease
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Pedro Ernesto, Universidade Federal do Rio de Janeiro, Hospital Couto Maia/SES/BA, Hospital São José de Doenças Infecciosas - HSJ / Secretaria de Saúde Fortaleza, Hospital Estadual Sumaré Dr. Leandro Francheschini, Universidade Federal de Santa Maria, Hospital Regional de São José - Dr. Homero de Miranda Gomes, Hospital dos Servidores do Estado do Rio de Janeiro, Federal University of Minas Gerais, Gaffree & Guinle Universitary Hospital, Hospital Nossa Senhora da Conceicao, Instituto de Infectologia Emílio Ribas
- Responsible party
- Principal investigator, Raquel Malaguthi de Souza, Evandro Chagas National Institute of Infectious Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807699
- Sponsor's protocol ID
- 32449420.4.1001.5262
- Acronym
- Recoversus
- Status last verified
- Mar 2021
- First submitted
- 18 Mar 2021
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rede Colaborativa Para Geração de Evidência Científica em COVID-19 Para o Sistema Único de Saúde no Brasil - RECOVER SUS-BRASIL
- ClinicalTrials.gov ID
- NCT04807699
- Acronym / sponsor ID
- Recoversus / 32449420.4.1001.5262
- Conditions
- Covid19, Hospitalization
- Keywords
- Covid-19, hospitalization, biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Evandro Chagas National Institute of Infectious DiseaseUniversity, hospital or other
- Collaborators
- Hospital Universitario Pedro Ernesto, Universidade Federal do Rio de Janeiro, Hospital Couto Maia/SES/BA, Hospital São José de Doenças Infecciosas - HSJ / Secretaria de Saúde Fortaleza, Hospital Estadual Sumaré Dr. Leandro Francheschini, Universidade Federal de Santa Maria, Hospital Regional de São José - Dr. Homero de Miranda Gomes, Hospital dos Servidores do Estado do Rio de Janeiro, Federal University of Minas Gerais, Gaffree & Guinle Universitary Hospital, Hospital Nossa Senhora da Conceicao, Instituto de Infectologia Emílio Ribas
- Study start
- 25 Jul 2020 (actual)
- Primary completion
- 25 Oct 2021 (estimated)
- Study completion
- 25 Mar 2022 (estimated)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total participants | – | Other: Data collection3500 participants that will have their medical forms checked |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionClinical and sociodemographic data collected through interview at admission and results of complementary tests performed during hospitalization. | Other | Total participants |
Primary outcome
The main outcome of the study is hospital mortality
Time frame: 25/05/2021
1 secondary outcome
Length of hospital stay
Time frame: 25/05/2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Hospitalization, run by Evandro Chagas National Institute of Infectious Disease at 13 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main outcome of the study is hospital mortality (time frame: 25/05/2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021; AzTrials last refreshed its copy on 27 Oct 2026.