Coronavirus infection, unspecified
Conditions
Interventions
Cohort study investigating approximately 2000 individuals aged 50 years or older admitted for COVID-19 to the Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP) in
Other
V03.175.500
Sponsors
Hospital das Clínicas da Faculdade de Medicina da USP
Hospital das Clínicas da Faculdade de Medicina da USP
Eligibility
Inclusion criteria
Inclusion criteria: We will include consecutive patients hospitalized for COVID-19, between March and July 2020. Patients are screened for eligbility at admission according to the following criteria: age greater than or equal to 50 years; suspected (signs and symptoms suggestive of the disease without confirmatory tests), probable (signs and symptoms suggestive of the disease with compatible tomographic image) or confirmed COVID-19 (agent detected by laboratory test), as per WHO guidelines; informed consent for participation in the study.
Exclusion criteria
Exclusion criteria: We will exclude patients for whom the diagnosis of COVID-19 is discarded during follow-up until the end of hospitalization (absence of a compatible tomographic image, negative virus detection tests, and alternative diagnosis more likely).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hospital death, and death at 30 days, 6 months, and 1 year. In-hospital death is evaluated by review of hospital records. Death at 30 days, 6 months and 1 year will be evaluated by telephone interviews. We expect a 10% difference in mortality between frail vs. robust individuals. | — |
Secondary
| Measure | Time frame |
|---|---|
| Length of hospital stay (days); patients in the upper tertile will be classified as prolonged hospital stay, assessed by medical record review. A higher risk of prolonged hospitalization is expected in frail individuals, measured by multivariate regression models (relative risk greater than 1).;Occurrence of Acute Respiratory Distress Syndrome (ARDS), assessed by reviewing medical record diagnoses. A higher risk of ARDS is expected in frail individuals, measured by multivariate regression models (relative risk greater than 1).;Need for mechanical ventilation (MV), assessed by review of medical records. A higher risk of MV is expected in frail individuals, measured by multivariate regression models (relative risk greater than 1).;Admission to the intensive care unit (ICU), assessed by review of medical records. A higher risk of admission to the ICU is expected in frail individuals, measured by multivariate regression models (relative risk greater than 1).;Length of ICU stay (days), assessed by review of medical records. A longer ICU stay is expected in frail individuals, measured by multivariate regression models (relative risk greater than 1).;Occurrence of delirium during hospital stay (yes or no), assessed by review of medical records. A higher risk of delirium is expected in older individuals, as measured by multivariate regression models (relative risk greater than 1).;Functional decline at 30 days, 6 months and 1 year after discharge, assessed by the BOMFAQ scale criteria. A higher risk is expected in older and frail individuals, as measured by multivariate regression models (relative risk greater than 1).;Frailty at 30 days, 6 months and 1 year post-discharge, assessed by the FRAIL scale and Clinical Frailty Scale (CFS) criteria. A higher risk is expected in older individuals, measured by multivariate regression models (relative risk greater than 1).;Health care utilization (admission to emergency units or hospitalization) within 30 days, 6 months, and 1 year | — |
Countries
Brazil
Contacts
Public ContactMárlon;Thiago Aliberti;Avelino-Silva
Hospital das Clínicas da Faculdade de Medicina da USP;Hospital das Clínicas da Faculdade de Medicina da USP
Outcome results
None listed