Characteristics and Outcomes of Patients With COVID-19 Admitted to the ICU (EpiCoV-Brazil)

University of Sao Paulo General Hospital

Status: Completed

Conditions: SARS-CoV 2; Corona Virus Infection; Respiratory Distress Syndrome, Adult; Critical Illness

Treatments: Other: risk factors

Study type: Observational

Funder types: Other

Identifiers

NCT04378582

31382620.0.0000.0068

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,589 patients

Sex: All

Ages: 14 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Being admitted to one of the COVID-19 ICUs during the study period
• Suspected or confirmed COVID-19
• Expected ICU stay greater than 24 hours

Exclusion criteria

• ICU Readmission during the same hospital stay (patients will be evaluated only during their first ICU stay)

Trial design

1,589 participants in 2 patient groups

COVID-19 confirmed

Description:

Patients with confirmed COVID-19 by RT-PCR or serological test

Treatment:

Other: risk factors

COVID-19 suspected

Description:

Patients suspected COVID-19, as defined by clinical history and course, who have negative RT-PCR or serological test but where treated and cared for as COVID-19 patients

Treatment:

Other: risk factors