NCT04336345

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2020

Completed
Last Updated

November 10, 2020

Status Verified

October 1, 2020

Enrollment Period

29 days

First QC Date

April 2, 2020

Last Update Submit

November 6, 2020

Conditions

Keywords

Intensive care unitCritical careOutcomesEpidemiology

Outcome Measures

Primary Outcomes (1)

  • Hospital mortality

    Mortality 30 days following hospital admission

    30 days

Secondary Outcomes (1)

  • Length of stay in the intensive care unit

    Through study completion, an average of 30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14000, Mexico

Location

All centres from Mexico willing to contribute are Welcome.

México, Mexico

Location

Related Publications (1)

  • Namendys-Silva SA, Alvarado-Avila PE, Dominguez-Cherit G, Rivero-Sigarroa E, Sanchez-Hurtado LA, Gutierrez-Villasenor A, Romero-Gonzalez JP, Rodriguez-Bautista H, Garcia-Briones A, Garnica-Camacho CE, Cruz-Ruiz NG, Gonzalez-Herrera MO, Garcia-Guillen FJ, Guerrero-Gutierrez MA, Salmeron-Gonzalez JD, Romero-Gutierrez L, Canto-Castro JL, Cervantes VH; Mexico COVID-19 Critical Care Collaborative Group. Outcomes of patients with COVID-19 in the intensive care unit in Mexico: A multicenter observational study. Heart Lung. 2021 Jan-Feb;50(1):28-32. doi: 10.1016/j.hrtlng.2020.10.013. Epub 2020 Oct 21.

MeSH Terms

Conditions

Coronavirus InfectionsCOVID-19

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Silvio A. Ñamendys-Silva, MD, MSc

    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    PRINCIPAL INVESTIGATOR
  • Guillermo Dominguez-Cherit, MD

    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    STUDY DIRECTOR
  • Eduardo Rivero-Sigarroa, MD

    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 2, 2020

First Posted

April 7, 2020

Study Start

April 1, 2020

Primary Completion

April 30, 2020

Study Completion

June 4, 2020

Last Updated

November 10, 2020

Record last verified: 2020-10

Locations