Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04807699 |
| Other study ID # |
32449420.4.1001.5262 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 25, 2020 |
| Est. completion date |
March 25, 2022 |
Study information
| Verified date |
March 2021 |
| Source |
Evandro Chagas National Institute of Infectious Disease |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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. 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.
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-de
medicamentos-siclom), laboratory tests (SISCEL - http :
//www.aids.gov.br/pt-br/sistema-de-informacao/sistema-de-controle-de-exameslaboratoriais-da-r
ede-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.
