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

NCT04456426 | Withdrawn DMC

• 1 other identifier: GRIVI_2020_01COVID
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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. 1.To establish the characteristics of patients and healthcare workers treated with COVID-19.
2. 2.To assess previous predisposing morbidity.
3. 3.To detail clinical factors associated with complications.
4. 4.To profile clinical indicators for severity and outcomes.

Conditions

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

Keywords

COVID; SARS; Viral Pneumonia; SARS-CoV 2; Coronavirus

Outcome Measures

Primary Outcomes (3)

• Mortality

  Death within 30 days of hospital admission

  30 days

• ICU admission

  Need for intensive care unit admission

  30 days

• Mechanical ventilation

  Need for intubation and invasive mechanical ventilation

  30 days

Secondary Outcomes (3)

• ICU length of stay

  30 days

• Hospital length of stay

  30 days

• Days of mechanical ventilation

  30 days

Study Arms (1)

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.

Eligibility Criteria

• Age: Up to 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• None.

Sponsors & Collaborators

• Hospital Departamental de Villavicencio: lead
• Clínica Primavera: collaborator
• Clínica Meta: collaborator
• Cooperative University of Colombia: collaborator
• Grupo de Investigación de Villavicencio: collaborator

Related Publications (8)

• 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.

  PMID: 31668196 RESULT

• 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.

  PMID: 32091533 RESULT

• 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.

  PMID: 32171076 RESULT

• 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.

  PMID: 32227758 RESULT

• 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.

  PMID: 32220208 RESULT

• 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.

  PMID: 32220207 RESULT

• 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.

  PMID: 32187459 RESULT

• 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.

  PMID: 32146445 RESULT

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; Disease; Pneumonia, Viral; Coronavirus Infections

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia; Lung Diseases

Study Officials

• Norton Perez, MD

  Grupo de Investigación de Villavicencio

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Critical Care Chief of Staff; professor of medicine

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: July 2, 2020
• Study Start: September 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 5, 2023

Record last verified: 2023-07