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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04456426
Recruitment Status : Not yet recruiting
First Posted : July 2, 2020
Last Update Posted : July 2, 2020
Sponsor:
Collaborators:
Clínica Primavera
Clínica Meta
Cooperative University of Colombia
Grupo de Investigación de Villavicencio
Information provided by (Responsible Party):
Norton Perez, Hospital Departamental de Villavicencio

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
COVID SARS-CoV 2 SARS Pneumonia SARS (Disease) SARS (Severe Acute Respiratory Syndrome)

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.

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Study Type : Observational
Estimated 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
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Mortality [ Time Frame: 30 days ]
    Death within 30 days of hospital admission

  2. ICU admission [ Time Frame: 30 days ]
    Need for intensive care unit admission

  3. Mechanical ventilation [ Time Frame: 30 days ]
    Need for intubation and invasive mechanical ventilation


Secondary Outcome Measures :
  1. ICU length of stay [ Time Frame: 30 days ]
    Duration of stay in the intensive care unit

  2. Hospital length of stay [ Time Frame: 30 days ]
    Duration of stay in hospitalization

  3. Days of mechanical ventilation [ Time Frame: 30 days ]
    Duration of mechanical ventilation included with intubation or tracheostomy



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04456426


Contacts
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Contact: Norton Perez, MD 3112517471 norton.perez@hotmail.com
Contact: Emma I Rodríguez, MSc 31125175328 emmaisa1@hotmail.com

Sponsors and Collaborators
Hospital Departamental de Villavicencio
Clínica Primavera
Clínica Meta
Cooperative University of Colombia
Grupo de Investigación de Villavicencio
Investigators
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Study Director: Norton Perez, MD Grupo de Investigación de Villavicencio
Publications of Results:

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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: July 2, 2020    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Not by the moment

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norton Perez, Hospital Departamental de Villavicencio:
COVID
SARS
Viral Pneumonia
SARS-CoV 2
Coronavirus
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases