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OBJECTIVES: We designed a cohort study to describe characteristics and outcomes of patients with coronavirus disease (COVID-19) admitted to the intensive care unit (ICU) in the largest public hospital in Sao Paulo, Brazil, as Latin America becomes the epicenter of the pandemic. METHODS: This is the protocol for a study being conducted at an academic hospital in Brazil with 300 adult ICU beds dedicated to COVID-19 patients. We will include adult patients admitted to the ICU with suspected or confirmed COVID-19 during the study period. The main outcome is ICU survival at 28 days. Data will be collected prospectively and retrospectively by trained investigators from the hospital’s electronic medical records, using an electronic data capture tool. We will collect data on demographics, comorbidities, severity of disease, and laboratorial test results at admission. Information on the need for advanced life support and ventilator parameters will be collected during ICU stay. Patients will be followed up for 28 days in the ICU and 60 days in the hospital. We will plot Kaplan-Meier curves to estimate ICU and hospital survival and perform survival analysis using the Cox proportional hazards model to identify the main risk factors for mortality. ClinicalTrials.gov: NCT04378582. RESULTS: We expect to include a large sample of patients with COVID-19 admitted to the ICU and to be able to provide data on admission characteristics, use of advanced life support, ICU survival at 28 days, and hospital survival at 60 days. CONCLUSIONS: This study will provide epidemiological data about critically ill patients with COVID-19 in Brazil, which could inform health policy and resource allocation in low- and middle-income countries.

Rationale: Recent reports suggest that patients with severe coronavirus disease (COVID-19) often experience long-term consequences of the infection. However, studies on intensive care unit (ICU) survivors are underrepresented. Objectives: We aimed to explore 12-month clinical outcomes after critical COVID-19, describing the longitudinal progress of disabilities, frailty status, frequency of cognitive impairment, and clinical events (rehospitalization, institutionalization, and falls). Methods: We performed a prospective cohort study of survivors of COVID-19 ICU admissions in Sao Paulo, Brazil. We assessed patients every 3 months for 1 year after hospital discharge and obtained information on 15 activities of daily living (basic, instrumental, and mobility activities), frailty, cognition, and clinical events. Results: We included 428 patients (mean age of 64 yr, 61% required invasive mechanical ventilation during ICU stay). The number of disabilities peaked at 3 months compared with the pre-COVID-19 period (mean difference, 2.46; 99% confidence interval, 1.94-2.99) and then decreased at 12 months (mean difference, 0.67; 99% confidence interval, 0.28-1.07). At 12-month follow-up, 12% of patients were frail, but half of them presented frailty only after COVID-19. The prevalence of cognitive symptoms was 17% at 3 months and progressively decreased to 12.1% (P=0.012 for trend) at the end of1 year. Clinical events occurred in all assessments. Conclusions: Although a higher burden of disabilities and cognitive symptoms occurred 3 months after hospital discharge of critical COVID-19 survivors, a significant improvement occurred during the 1-year follow-up. However, one-third of the patients remained in worse conditions than their pre-COVID-19 status. [ABSTRACT FROM AUTHOR]