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Outcomes of Patients With COVID-19 in the Intensive Care Unit (MexCOVID-19)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04336345
Recruitment Status : Completed
First Posted : April 7, 2020
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
Silvio A. Ñamendys-Silva, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study Description
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Brief Summary:

The objective of this study is to evaluate the clinical characteristics and outcomes of critically ill patients with COVID-19 admitted to the intensive care unit.

A Multicenter Observational Study.


Condition or disease
Coronavirus Infections COVID-19 Viral Pneumonia Human Coronavirus

Detailed Description:
As of 23 March 2020, a cumulative total of 332,930 confirmed cases of coronavirus disease 2019 (COVID-19) were reported in 189 countries and territories worldwide. As of this time, there had been 367 total confirmed cases of COVID-19, including four deaths in Mexico. The clinical manifestations of patients with COVID-19 are wide, asymptomatic infection, mild upper respiratory tract illness, and approximately 5% of critically ill patients with COVID-19 have presented rapidly progressive respiratory failure, development of acute respiratory distress syndrome (ARDS), and intensive care unit (ICU) admission. On March 24, 2020, the Secretary of Health of Mexico, formally declared the beginning of phase 2. It has been estimated that many confirmed cases of COVID-19 would occur, thus would result in a significant increase of hospital and ICU admissions.
Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Month
Official Title: Outcomes of Patients With COVID-19 in the Intensive Care Unit: A National Observational Study (Mexico COVID-19 ICU Study)
Actual Study Start Date : April 1, 2020
Actual Primary Completion Date : April 30, 2020
Actual Study Completion Date : June 4, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Hospital mortality [ Time Frame: 30 days ]
    Mortality 30 days following hospital admission


Secondary Outcome Measures :
  1. Length of stay in the intensive care unit [ Time Frame: Through study completion, an average of 30 days ]
    The number of calendar days from the day of admission (counted as 1 day) to day of intensive care unit discharge


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill patients aged over 18 years with a positive for SARS-CoV-2 result required admission to an intensive care unit or critical care in other areas of the hospital (critical care surge capacity).
Criteria

Inclusion Criteria:

  • Confirmed case: Critically ill patient who meets the operational definition of a suspected case and who has a confirmed diagnosis by the National Network of Public Health Laboratories recognized by the Institute of Epidemiological Diagnosis and Reference (Indre) (Mexico).

Exclusion Criteria:

  • If a negative for SARS-CoV-2 result is obtained from a critically ill patient with a high index of suspicion for COVID-19 virus infection.
  • Patients who had participated in another observational study in the last 30 days prior to inclusion.
Contacts and Locations
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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): NCT04336345


Locations
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Mexico
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Mexico, 14000
All centres from Mexico willing to contribute are Welcome.
Mexico, Mexico
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
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Principal Investigator: Silvio A. Ñamendys-Silva, MD, MSc Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study Director: Guillermo Dominguez-Cherit, MD Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study Chair: Eduardo Rivero-Sigarroa, MD Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
More Information
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Publications of Results:

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Responsible Party: Silvio A. Ñamendys-Silva, Principal Investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT04336345    
Other Study ID Numbers: 3336
First Posted: April 7, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: All IPD that underlie could results in a publication.

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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 Silvio A. Ñamendys-Silva, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
Intensive care unit
Critical care
Outcomes
Epidemiology
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Pneumonia, Viral
Respiratory Tract Infections
Infections
Pneumonia
 Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases