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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04456426
Other study ID # GRIVI_2020_01COVID
Secondary ID
Status Withdrawn
Phase
First received
Last updated
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
Health authority
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Status Withdrawn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.

Study Design


Related Conditions & MeSH terms


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
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