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

COVID-19 Clinical Trial

— MexCOVID-19  

Official title:

Outcomes of Patients With COVID-19 in the Intensive Care Unit: A National Observational Study (Mexico COVID-19 ICU Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04336345
• Other study ID #: 3336
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: June 4, 2020

Study information

• Verified date: October 2020
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 4, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID-19
• Pneumonia
• Pneumonia, Viral
• Severe Acute Respiratory Syndrome
• Viral Pneumonia Human Coronavirus

Locations

Country	Name	City	State
Mexico	All centres from Mexico willing to contribute are Welcome.	Mexico
Mexico	Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

Ñamendys-Silva SA, Alvarado-Ávila PE, Domínguez-Cherit G, et al. Outcomes of patients with COVID-19 in the intensive care unit in Mexico: A multicenter observational study [published online ahead of print, 2020 Oct 21]. Heart Lung. 2020;S0147-9563(20)3041

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital mortality	Mortality 30 days following hospital admission	30 days
Secondary	Length of stay in the intensive care unit	The number of calendar days from the day of admission (counted as 1 day) to day of intensive care unit discharge	Through study completion, an average of 30 days

External Links

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