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

Critical Illness Clinical Trial

— EpiCoV-Brazil  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04378582
• Other study ID #: 31382620.0.0000.0068
• Status: Completed
• Start date: May 7, 2020
• Est. completion date: August 5, 2020

Study information

• Verified date: August 2020
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1589
• Est. completion date: August 5, 2020
• Est. primary completion date: July 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Lung Injury
• Corona Virus Infection
• Coronavirus Infections
• Critical Illness
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• SARS-CoV 2
• Severe Acute Respiratory Syndrome

Intervention

Other:
• risk factors
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

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas -HCFMUSP	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU survival at 28 days	the proportion of patients who survive to ICU discharge or for 28 days in the ICU	28 days
Secondary	Hospital survival at 60 days	the proportion of patients who survive to hospital discharge or for 60 days in the hospital	60 days
Secondary	Duration of mechanical ventilation	Number of days under invasive ventilatory support	28 days
Secondary	Need for renal replacement therapy	Proportion of patients who received renal replacement therapy during the ICU stay	28 days
Secondary	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