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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04378582
Recruitment Status : Recruiting
First Posted : May 7, 2020
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Juliana Carvalho Ferreira, University of Sao Paulo General Hospital

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.


Condition or disease Intervention/treatment
SARS-CoV 2 Respiratory Distress Syndrome, Adult Corona Virus Infection Critical Illness Other: risk factors

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Characteristics and Outcomes of Patients With COVID-19 Admitted to the ICU
Actual Study Start Date : May 7, 2020
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : December 31, 2020


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   14 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04378582


Contacts
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Contact: Juliana C Ferreira, MD +5511983355876 juliana.ferreira@hc.fm.usp.br

Locations
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Brazil
Hospital das Clínicas -HCFMUSP Recruiting
Sao Paulo, SP, Brazil, 05403010
Contact: Juliana C Ferreira, MD    +5511983355876      
Principal Investigator: juliana ferreira, MD         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Juliana C Ferreira, MD University of Sao Paulo - hospital das Clínicas da faculdade de medicina da USP (HCFMUSP)
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Responsible Party: Juliana Carvalho Ferreira, Assistant professor, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT04378582    
Other Study ID Numbers: 31382620.0.0000.0068
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juliana Carvalho Ferreira, University of Sao Paulo General Hospital:
Critical Care
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Critical Illness
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Virus Diseases
Disease Attributes
Pathologic Processes
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Lung Injury