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

Completed

• Conditions: COVID-19; Viral Pneumonia Human Coronavirus; Coronavirus Infections

• Registration Number: NCT04336345
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.

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 Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2020-04-02
• Study First Submitted QC: 2020-04-03
• Study First Posted: 2020-04-07
• Primary Completion: 2020-04-30
• Study Completion: 2020-06-04
• Status Verified: 2020-10
• Last Update Submitted: 2020-11-06
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hospital mortality	30 days	Mortality 30 days following hospital admission

Secondary Outcome Measures

Name	Time	Method
Length of stay in the intensive care unit	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

Trial Locations

Locations (2)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán; 🇲🇽 Mexico City, Mexico

All centres from Mexico willing to contribute are Welcome.; 🇲🇽 Mexico, Mexico