Characteristics and Outcomes of Patients With COVID-19 Admitted to the ICU

Study Overview
=================
Brief 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.

Official Title
-----------------
Characteristics and Outcomes of Patients With COVID-19 Admitted to the ICU

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

Intervention / Treatment
-----------------
* Other: risk factors


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 confirmed<br>Patients with confirmed COVID-19 by RT-PCR or serological test | Other: risk factors<br>* 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<br>* Other names: need for advanced life support;|
| COVID-19 suspected<br>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 | Other: risk factors<br>* 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<br>* Other names: need for advanced life support;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU survival at 28 days | the proportion of patients who survive to ICU discharge or for 28 days in the ICU | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital survival at 60 days | the proportion of patients who survive to hospital discharge or for 60 days in the hospital | 60 days | 
| Duration of mechanical ventilation | Number of days under invasive ventilatory support | 28 days | 
| Need for renal replacement therapy | Proportion of patients who received renal replacement therapy during the ICU stay | 28 days | 
| Complications during the ICU stay | percentage of patients who developed complications during the ICU stay: thromboembolic events, ventilator associated pneumonia, secondary infections, cardiovascular complications | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Critical Care