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Completed

NCT Number: NCT04378582

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

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.

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Key information

Conditions

SARS-CoV 2 Corona Virus Infection Coronaviridae Infections Coronavirus Infections Critical Illness Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Respiration Disorders Respiratory Distress Syndrome Respiratory Distress Syndrome, Adult Respiratory Tract Diseases Virus Diseases

Age range

14 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital das Clínicas -HCFMUSP

São Paulo, 05403010, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

risk factors

Other

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 names: demographics, comorbidities, mechanical ventilation parameters, need for advanced life support

Primary outcomes

  1. ICU survival at 28 days

    Time frame: 28 days

    the proportion of patients who survive to ICU discharge or for 28 days in the ICU

Secondary outcomes

  1. Hospital survival at 60 days

    Time frame: 60 days

    the proportion of patients who survive to hospital discharge or for 60 days in the hospital

  2. Duration of mechanical ventilation

    Time frame: 28 days

    Number of days under invasive ventilatory support

  3. Need for renal replacement therapy

    Time frame: 28 days

    Proportion of patients who received renal replacement therapy during the ICU stay

  4. Complications during the ICU stay

    Time frame: 28 days

    percentage of patients who developed complications during the ICU stay: thromboembolic events, ventilator associated pneumonia, secondary infections, cardiovascular complications

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Acronym: EpiCoV-Brazil

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 7, 2020
Registry last updated
Aug 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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