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Clinical Trials/NCT04456426
NCT04456426
Withdrawn
N/A

Evaluation of the Characteristics of Patients With Suspected or Confirmed of COVID-19 in Villavicencio and Meta State, Colombia

Hospital Departamental de Villavicencio0 sitesSeptember 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
COVID
Sponsor
Hospital Departamental de Villavicencio
Primary Endpoint
Mechanical ventilation
Status
Withdrawn
Last Updated
2 years ago

Overview

Brief Summary

This observational study aims to collect detailed clinical information on confirmed or suspected patients of COVID-19 treated in hospitals from Meta State, Colombia. The objectives are:

  1. To establish the characteristics of patients and healthcare workers treated with COVID-19.
  2. To assess previous predisposing morbidity.
  3. To detail clinical factors associated with complications.
  4. To profile clinical indicators for severity and outcomes.

Detailed Description

Hospital database and clinical charts in an electronic format of patients with suspected or confirmed COVID-19 will be reviewed to include in the study. Multiple centers from the eastern Colombian prairies caring for this population will participate to provide an understanding of the behavior of the epidemic and accurate clinical comprehension of the disease. Healthcare centers involved in providing an evaluation of patients infected with SARS-CoV-2 will be invited to participate. The study will focus on the routine or new treatment strategies provided and a large population of patients analyzed would be desirable. It will allow identifying the most relevant factors associated with clinical outcomes, complications, and prognosis, with an appropriate statistical methodology for the analysis of observational nature. Variables of individuals assisted will be recorded as well as the end results, such as baseline characteristics of individuals and disease, and main outcomes such as mortality, need for ICU attention, mechanical ventilation, and length of stay. These results will be used to promote an improvement in the quality of care and individual and cluster decisions in the region.

Registry
clinicaltrials.gov
Start Date
September 1, 2021
End Date
December 31, 2021
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hospital Departamental de Villavicencio
Responsible Party
Principal Investigator
Principal Investigator

Norton Perez-Gutierrez, MD

Critical Care Chief of Staff; professor of medicine

Hospital Departamental de Villavicencio

Eligibility Criteria

Inclusion Criteria

  • Patients admitted to participant institutions with respiratory symptoms or diagnosed as compatible with COVID-19.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Mechanical ventilation

Time Frame: 30 days

Need for intubation and invasive mechanical ventilation

Mortality

Time Frame: 30 days

Death within 30 days of hospital admission

ICU admission

Time Frame: 30 days

Need for intensive care unit admission

Secondary Outcomes

  • Hospital length of stay(30 days)
  • Days of mechanical ventilation(30 days)
  • ICU length of stay(30 days)

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