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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04336345
Other study ID # 3336
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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