Characteristics of Patients and Healthcare Workers With COVID-19 in Meta State, Colombia
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|ClinicalTrials.gov Identifier: NCT04456426|
Recruitment Status : Not yet recruiting
First Posted : July 2, 2020
Last Update Posted : July 2, 2020
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:
- To establish the characteristics of patients and healthcare workers treated with COVID-19.
- To assess previous predisposing morbidity.
- To detail clinical factors associated with complications.
- To profile clinical indicators for severity and outcomes.
|Condition or disease|
|COVID SARS-CoV 2 SARS Pneumonia SARS (Disease) SARS (Severe Acute Respiratory Syndrome)|
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|
|Estimated Enrollment :||250 participants|
|Observational Model:||Ecologic or Community|
|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|
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.
- Mortality [ Time Frame: 30 days ]Death within 30 days of hospital admission
- ICU admission [ Time Frame: 30 days ]Need for intensive care unit admission
- Mechanical ventilation [ Time Frame: 30 days ]Need for intubation and invasive mechanical ventilation
- ICU length of stay [ Time Frame: 30 days ]Duration of stay in the intensive care unit
- Hospital length of stay [ Time Frame: 30 days ]Duration of stay in hospitalization
- Days of mechanical ventilation [ Time Frame: 30 days ]Duration of mechanical ventilation included with intubation or tracheostomy
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
|Contact: Norton Perez, MDfirstname.lastname@example.org|
|Contact: Emma I Rodríguez, MScemail@example.com|
|Study Director:||Norton Perez, MD||Grupo de Investigación de Villavicencio|