Clinical trial NCT04456426: Characteristics of Patients With COVID-19 in Meta State, Colombia
Official title: Evaluation of the Characteristics of Patients With Suspected or Confirmed of COVID-19 in Villavicencio and Meta State, Colombia
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: COVID
SARS-CoV 2
SARS Pneumonia
SARS (Disease)
SARS (Severe Acute Respiratory Syndrome)
Keywords: COVID
SARS
Viral Pneumonia
SARS-CoV 2
Coronavirus
Lead sponsor: Hospital Departamental de Villavicencio
Sponsor class: OTHER
Collaborators: name: Clínica Primavera
name: Clínica Meta
name: Cooperative University of Colombia
name: Grupo de Investigación de Villavicencio
First posted: 2020-07-02
Enrollment: 0
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None.

Primary outcomes:
measure: Mortality
timeFrame: 30 days
measure: ICU admission
timeFrame: 30 days
measure: Mechanical ventilation
timeFrame: 30 days
Secondary outcomes:
measure: ICU length of stay
timeFrame: 30 days
measure: Hospital length of stay
timeFrame: 30 days
measure: Days of mechanical ventilation
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Grupo de Investigación de Villavicencio
name: Norton Perez, MD
role: STUDY_DIRECTOR
References:
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.
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. doi: 10.1001/jama.2020.2648. No abstract available.
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 study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
citation: 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 - Case Series. N Engl J Med. 2020 May 21;382(21):2012-2022. doi: 10.1056/NEJMoa2004500. Epub 2020 Mar 30.
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, Oakley LP, Jacobs JR, Stone ND, Reddy SC, Jernigan JA, Honein MA, Clark TA, Duchin JS; Public Health-Seattle and King County, EvergreenHealth, and CDC COVID-19 Investigation Team. Epidemiology of Covid-19 in a Long-Term Care Facility in King County, Washington. N Engl J Med. 2020 May 21;382(21):2005-2011. doi: 10.1056/NEJMoa2005412. Epub 2020 Mar 27.
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.
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.
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.