Characteristics and Outcomes of Patients With COVID-19 Admitted to the ICU
Condition: SARS-CoV 2; Respiratory Distress Syndrome, Adult; Corona Virus Infection; Critical Illness
MeSH terms: Coronavirus Infections; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Critical Illness
Study type: Observational

Summary: 
      This is a case series of patients with COVID-19 admitted to the largest university hospital
      in Sao Paulo, Brazil, during the 2020 COVID-19 pandemic. Data will be collected prospectively
      and retrospectively.

      The main objective is to describe the characteristics of critically ill patients with
      COVID-19 and their clinical outcomes, and to identify risk factors associated with survival,
      to inform clinical decision-making and to guide the strategy to mitigate the epidemic, both
      within each hospital and ICU and in public health management.
    

Detailed description: 
      In December 2019, an outbreak of Severe Acute Respiratory Syndrome (SARS) attributed to a new
      coronavirus, called SARS-CoV-2, was described in the Wuhan region of China. This SARS, caused
      by SARS-CoV-2 was called COVID-19, spread across the globe, causing millions of cases on all
      continents, and thousands of deaths, being characterized as a pandemic.

      COVID-19 is characterized by a flu-like syndrome, with symptoms such as fever, cough, myalgia
      and gastrointestinal symptoms. Most cases are mild, some even asymptomatic, but approximately
      15% of patients have more severe presentation, and approximately 5% are critical (7).

      The acute respiratory failure of critically ill patients with COVID-19 has different aspects,
      including hypoxemia of difficult treatment, associated in some cases with clotting disorders,
      changes in immunity and inflammatory phenomena that pose challenges for the management of
      these patients, whose mortality can be high.

      The Hospital das Clínicas da Faculdade de Medicina de São Paulo implemented an action plan
      that provides for the creation of 200 ICU beds to serve patients with COVID-19. Knowing the
      characteristics of critically ill patients with COVID-19 and their clinical outcomes is
      extremely important to inform clinical decision-making and to guide the strategy to mitigate
      the epidemic, both within each hospital and ICU and in public health management.
    

Intervention name(s): risk factors
Intervention type(s): Other
Intervention description(s): This is an observational study, so there are no interventions. Investigators will collect data about demographics, comorbidities, and other risk factors such as severity of disease at admission, need for advanced life support, need for invasive mechanical ventilation and ventilator parameters on day1 of mechanical ventilation or ICU admission as potentially association with survival
Other intervention name(s): demographics; comorbidities; mechanical ventilation parameters; need for advanced life support
Observational model: Case-Only
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Patients with confirmed COVID-19 by RT-PCR or sorological test, or suspected COVID-19, as
        defined by clinical history and course, who have negative RT-PCR or sorological test but
        where treated and cared for as COVID-19 patients, who are admitted to the ICU during the
        study period.

        Data will be collected prospectively for patients admitted to the ICU after the the date of
        study approval and retrospectively for patients admitted to the ICU during the COVID-19
        epidemic in sao paulo, but before the study was initiated.

        A sample size of 300 patients was inittialy anticipated. As the epidemic in Sao Paulo grew
        fast, the hospital opened new ICU beds and the investigators reviewed the anticipated
        sample size to 500 patients. Given that the study has no risks for participants, and that
        informed consent was waived by the IRB, investigators intend to collect data about all
        patients with COVID-19 admitted to the ICUs during the study period, possibly more than the
        anticipated sample size.
      
Keywords: Critical Care