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
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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|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||150 participants|
|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|
- Hospital mortality [ Time Frame: 30 days ]Mortality 30 days following hospital admission
- 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
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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|
- 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).
- 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.
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
|Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán|
|Mexico City, Mexico, 14000|
|All centres from Mexico willing to contribute are Welcome.|
|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|
|Responsible Party:||Silvio A. Ñamendys-Silva, Principal Investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran|
|Other Study ID Numbers:||
|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.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Intensive care unit
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases