Characteristics of Patients With COVID-19 in Meta State, Colombia

July 1, 2023 updated by: Norton Perez-Gutierrez, MD, Hospital Departamental de Villavicencio

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

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.

Study Overview

Status

Withdrawn

Conditions

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient with respiratory symptoms compatible with a disease which might eventually result to be COVID-19 or not.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Patients treated with COVID-19
All populations of patients admitted with COVID-19 in healthcare institutions involved. No intervention but standard care designed by national guidelines will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 30 days
Death within 30 days of hospital admission
30 days
ICU admission
Time Frame: 30 days
Need for intensive care unit admission
30 days
Mechanical ventilation
Time Frame: 30 days
Need for intubation and invasive mechanical ventilation
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU length of stay
Time Frame: 30 days
Duration of stay in the intensive care unit
30 days
Hospital length of stay
Time Frame: 30 days
Duration of stay in hospitalization
30 days
Days of mechanical ventilation
Time Frame: 30 days
Duration of mechanical ventilation included with intubation or tracheostomy
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Departamental de Villavicencio

Collaborators

Cooperative University of Colombia
Clinica Primavera
Clínica Meta
Grupo de Investigación de Villavicencio

Investigators

  • Study Director: Norton Perez, MD, Grupo de Investigación de Villavicencio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

May 29, 2020

First Submitted That Met QC Criteria

July 1, 2020

First Posted (Actual)

July 2, 2020

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

July 1, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRIVI_2020_01COVID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Mendeley Data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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