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

August 25, 2020 updated by: Juliana Carvalho Ferreira, University of Sao Paulo General Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1589

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 05403010
        • Hospital das Clínicas -HCFMUSP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with confirmed COVID-19 by RT-PCR or sorological test, or suspected COVID-19, as defined by clinical history and course, who have negative RT-PCR or sorological test but where treated and cared for as COVID-19 patients, who are admitted to the ICU during the study period.

Data will be collected prospectively for patients admitted to the ICU after the the date of study approval and retrospectively for patients admitted to the ICU during the COVID-19 epidemic in sao paulo, but before the study was initiated.

A sample size of 300 patients was inittialy anticipated. As the epidemic in Sao Paulo grew fast, the hospital opened new ICU beds and the investigators reviewed the anticipated sample size to 500 patients. Given that the study has no risks for participants, and that informed consent was waived by the IRB, investigators intend to collect data about all patients with COVID-19 admitted to the ICUs during the study period, possibly more than the anticipated sample size.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID-19 confirmed
Patients with confirmed COVID-19 by RT-PCR or serological test
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
Other Names:
  • demographics
  • comorbidities
  • mechanical ventilation parameters
  • need for advanced life support
COVID-19 suspected
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
60 days
Duration of mechanical ventilation
Time Frame: 28 days
Number of days under invasive ventilatory support
28 days
Need for renal replacement therapy
Time Frame: 28 days
Proportion of patients who received renal replacement therapy during the ICU stay
28 days
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
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Juliana C Ferreira, MD, University of Sao Paulo - hospital das Clínicas da faculdade de medicina da USP (HCFMUSP)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2020

Primary Completion (Actual)

July 28, 2020

Study Completion (Actual)

August 5, 2020

Study Registration Dates

First Submitted

May 5, 2020

First Submitted That Met QC Criteria

May 5, 2020

First Posted (Actual)

May 7, 2020

Study Record Updates

Last Update Posted (Actual)

August 26, 2020

Last Update Submitted That Met QC Criteria

August 25, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31382620.0.0000.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

The investigators haven't developed a plan for sharing, but would be open to share unidentified data for research or public health purposes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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