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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04378582
Acronym
EpiCoV-Brazil
Enrollment
1589
Registered
2020-05-07
Start date
2020-05-07
Completion date
2020-08-05
Last updated
2020-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Critical Care

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.

Interventions

OTHERrisk 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

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
14 Years to 100 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
ICU survival at 28 days28 daysthe proportion of patients who survive to ICU discharge or for 28 days in the ICU

Secondary

MeasureTime frameDescription
Hospital survival at 60 days60 daysthe proportion of patients who survive to hospital discharge or for 60 days in the hospital
Duration of mechanical ventilation28 daysNumber of days under invasive ventilatory support
Need for renal replacement therapy28 daysProportion of patients who received renal replacement therapy during the ICU stay
Complications during the ICU stay28 dayspercentage of patients who developed complications during the ICU stay: thromboembolic events, ventilator associated pneumonia, secondary infections, cardiovascular complications

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026