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

COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04456426
• Other study ID #: GRIVI_2020_01COVID
• Status: Withdrawn
• Start date: September 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2023
• Source: Hospital Departamental de Villavicencio
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 120 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Hospital Departamental de Villavicencio	Clínica Meta, Clínica Primavera, Cooperative University of Colombia, Grupo de Investigación de Villavicencio

References & Publications (8)

Bhatraju PK, Ghassemieh BJ, Nichols M, Kim R, Jerome KR, Nalla AK, Greninger AL, Pipavath S, Wurfel MM, Evans L, Kritek PA, West TE, Luks A, Gerbino A, Dale CR, Goldman JD, O'Mahony S, Mikacenic C. Covid-19 in Critically Ill Patients in the Seattle Region — View Citation

Hui DSC, Zumla A. Severe Acute Respiratory Syndrome: Historical, Epidemiologic, and Clinical Features. Infect Dis Clin North Am. 2019 Dec;33(4):869-889. doi: 10.1016/j.idc.2019.07.001. — View Citation

McMichael TM, Currie DW, Clark S, Pogosjans S, Kay M, Schwartz NG, Lewis J, Baer A, Kawakami V, Lukoff MD, Ferro J, Brostrom-Smith C, Rea TD, Sayre MR, Riedo FX, Russell D, Hiatt B, Montgomery P, Rao AK, Chow EJ, Tobolowsky F, Hughes MJ, Bardossy AC, Oakl — View Citation

Page KR, Venkataramani M, Beyrer C, Polk S. Undocumented U.S. Immigrants and Covid-19. N Engl J Med. 2020 May 21;382(21):e62. doi: 10.1056/NEJMp2005953. Epub 2020 Mar 27. No abstract available. — View Citation

Porcheddu R, Serra C, Kelvin D, Kelvin N, Rubino S. Similarity in Case Fatality Rates (CFR) of COVID-19/SARS-COV-2 in Italy and China. J Infect Dev Ctries. 2020 Feb 29;14(2):125-128. doi: 10.3855/jidc.12600. — View Citation

Rosenbaum L. Facing Covid-19 in Italy - Ethics, Logistics, and Therapeutics on the Epidemic's Front Line. N Engl J Med. 2020 May 14;382(20):1873-1875. doi: 10.1056/NEJMp2005492. Epub 2020 Mar 18. No abstract available. — View Citation

Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. — View Citation

Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Death within 30 days of hospital admission	30 days
Primary	ICU admission	Need for intensive care unit admission	30 days
Primary	Mechanical ventilation	Need for intubation and invasive mechanical ventilation	30 days
Secondary	ICU length of stay	Duration of stay in the intensive care unit	30 days
Secondary	Hospital length of stay	Duration of stay in hospitalization	30 days
Secondary	Days of mechanical ventilation	Duration of mechanical ventilation included with intubation or tracheostomy	30 days