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

Withdrawn

• Conditions: COVID; SARS-CoV 2; SARS (Disease); SARS (Severe Acute Respiratory Syndrome); SARS Pneumonia

• Registration Number: NCT04456426
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-05-29
• Study First Submitted QC: 2020-07-01
• Study First Posted: 2020-07-02
• Study Start: 2021-09-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-01
• Last Update Posted: 2023-07-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mechanical ventilation	30 days	Need for intubation and invasive mechanical ventilation
Mortality	30 days	Death within 30 days of hospital admission
ICU admission	30 days	Need for intensive care unit admission

Secondary Outcome Measures

Name	Time	Method
Hospital length of stay	30 days	Duration of stay in hospitalization
Days of mechanical ventilation	30 days	Duration of mechanical ventilation included with intubation or tracheostomy
ICU length of stay	30 days	Duration of stay in the intensive care unit