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

Sponsor
Hospital Departamental de Villavicencio (Other)
Overall Status
Unknown status
CT.gov ID
NCT04456426
Collaborator
Clínica Primavera (Other), Clínica Meta (Other), Cooperative University of Colombia (Other), Grupo de Investigación de Villavicencio (Other)
250
Enrollment
1
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Retrospective
    Official Title:
    Evaluation of the Characteristics of Patients and Healthcare Workers With Suspected or Confirmed of COVID-19 in Villavicencio and Meta State, Colombia
    Anticipated Study Start Date :
    Jul 1, 2020
    Anticipated Primary Completion Date :
    Aug 1, 2020
    Anticipated Study Completion Date :
    Aug 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Mortality [30 days]

      Death within 30 days of hospital admission

    2. ICU admission [30 days]

      Need for intensive care unit admission

    3. Mechanical ventilation [30 days]

      Need for intubation and invasive mechanical ventilation

    Secondary Outcome Measures

    1. ICU length of stay [30 days]

      Duration of stay in the intensive care unit

    2. Hospital length of stay [30 days]

      Duration of stay in hospitalization

    3. Days of mechanical ventilation [30 days]

      Duration of mechanical ventilation included with intubation or tracheostomy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients admitted to participant institutions with respiratory symptoms or diagnosed as compatible with COVID-19.
    Exclusion Criteria:
    • None.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hospital Departamental de Villavicencio
    • Clínica Primavera
    • Clínica Meta
    • Cooperative University of Colombia
    • Grupo de Investigación de Villavicencio

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Norton Perez, Critical Care Chief of Staff; professor of medicine, Hospital Departamental de Villavicencio
    ClinicalTrials.gov Identifier:
    NCT04456426
    Other Study ID Numbers:
    • GRIVI_2020_01COVID
    First Posted:
    Jul 2, 2020
    Last Update Posted:
    Jul 2, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Norton Perez, Critical Care Chief of Staff; professor of medicine, Hospital Departamental de Villavicencio
    COVID
    SARS
    Viral Pneumonia
    SARS-CoV 2
    Coronavirus
    Additional relevant MeSH terms:
    Pneumonia
    Severe Acute Respiratory Syndrome

    Study Results

    No Results Posted as of Jul 2, 2020