<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04456426</url>
  </required_header>
  <id_info>
    <org_study_id>GRIVI_2020_01COVID</org_study_id>
    <nct_id>NCT04456426</nct_id>
  </id_info>
  <brief_title>Characteristics of Patients With COVID-19 in Meta State, Colombia</brief_title>
  <official_title>Evaluation of the Characteristics of Patients With Suspected or Confirmed of COVID-19 in Villavicencio and Meta State, Colombia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Departamental de Villavicencio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Clínica Primavera</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Clínica Meta</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cooperative University of Colombia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Grupo de Investigación de Villavicencio</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Departamental de Villavicencio</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This observational study aims to collect detailed clinical information on confirmed or&#xD;
      suspected patients of COVID-19 treated in hospitals from Meta State, Colombia. The objectives&#xD;
      are:&#xD;
&#xD;
        1. To establish the characteristics of patients and healthcare workers treated with&#xD;
           COVID-19.&#xD;
&#xD;
        2. To assess previous predisposing morbidity.&#xD;
&#xD;
        3. To detail clinical factors associated with complications.&#xD;
&#xD;
        4. To profile clinical indicators for severity and outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hospital database and clinical charts in an electronic format of patients with suspected or&#xD;
      confirmed COVID-19 will be reviewed to include in the study. Multiple centers from the&#xD;
      eastern Colombian prairies caring for this population will participate to provide an&#xD;
      understanding of the behavior of the epidemic and accurate clinical comprehension of the&#xD;
      disease. Healthcare centers involved in providing an evaluation of patients infected with&#xD;
      SARS-CoV-2 will be invited to participate.&#xD;
&#xD;
      The study will focus on the routine or new treatment strategies provided and a large&#xD;
      population of patients analyzed would be desirable. It will allow identifying the most&#xD;
      relevant factors associated with clinical outcomes, complications, and prognosis, with an&#xD;
      appropriate statistical methodology for the analysis of observational nature.&#xD;
&#xD;
      Variables of individuals assisted will be recorded as well as the end results, such as&#xD;
      baseline characteristics of individuals and disease, and main outcomes such as mortality,&#xD;
      need for ICU attention, mechanical ventilation, and length of stay.&#xD;
&#xD;
      These results will be used to promote an improvement in the quality of care and individual&#xD;
      and cluster decisions in the region.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No access to the database of healthcare workers.&#xD;
  </why_stopped>
  <start_date type="Actual">September 1, 2021</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>30 days</time_frame>
    <description>Death within 30 days of hospital admission</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ICU admission</measure>
    <time_frame>30 days</time_frame>
    <description>Need for intensive care unit admission</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mechanical ventilation</measure>
    <time_frame>30 days</time_frame>
    <description>Need for intubation and invasive mechanical ventilation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>30 days</time_frame>
    <description>Duration of stay in the intensive care unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>30 days</time_frame>
    <description>Duration of stay in hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days of mechanical ventilation</measure>
    <time_frame>30 days</time_frame>
    <description>Duration of mechanical ventilation included with intubation or tracheostomy</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>COVID</condition>
  <condition>SARS-CoV 2</condition>
  <condition>SARS Pneumonia</condition>
  <condition>SARS (Disease)</condition>
  <condition>SARS (Severe Acute Respiratory Syndrome)</condition>
  <arm_group>
    <arm_group_label>Patients treated with COVID-19</arm_group_label>
    <description>All populations of patients admitted with COVID-19 in healthcare institutions involved. No intervention but standard care designed by national guidelines will be provided.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with respiratory symptoms compatible with a disease which might eventually result&#xD;
        to be COVID-19 or not.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted to participant institutions with respiratory symptoms or diagnosed&#xD;
             as compatible with COVID-19.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Norton Perez, MD</last_name>
    <role>Study Director</role>
    <affiliation>Grupo de Investigación de Villavicencio</affiliation>
  </overall_official>
  <results_reference>
    <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>
    <PMID>31668196</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>32091533</PMID>
  </results_reference>
  <results_reference>
    <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. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.</citation>
    <PMID>32171076</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>32227758</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>32220208</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>32220207</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>32187459</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>32146445</PMID>
  </results_reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>July 1, 2023</last_update_submitted>
  <last_update_submitted_qc>July 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Departamental de Villavicencio</investigator_affiliation>
    <investigator_full_name>Norton Perez-Gutierrez, MD</investigator_full_name>
    <investigator_title>Critical Care Chief of Staff; professor of medicine</investigator_title>
  </responsible_party>
  <keyword>COVID</keyword>
  <keyword>SARS</keyword>
  <keyword>Viral Pneumonia</keyword>
  <keyword>SARS-CoV 2</keyword>
  <keyword>Coronavirus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Severe Acute Respiratory Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Mendeley Data</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04456426
org study id: GRIVI_2020_01COVID
nct id: NCT04456426
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Ecologic or Community
time perspective: Retrospective
measure: Mortality
time frame: 30 days
description: Death within 30 days of hospital admission
measure: ICU admission
time frame: 30 days
description: Need for intensive care unit admission
measure: Mechanical ventilation
time frame: 30 days
description: Need for intubation and invasive mechanical ventilation
measure: ICU length of stay
time frame: 30 days
description: Duration of stay in the intensive care unit
measure: Hospital length of stay
time frame: 30 days
description: Duration of stay in hospitalization
measure: Days of mechanical ventilation
time frame: 30 days
description: Duration of mechanical ventilation included with intubation or tracheostomy
arm group label: Patients treated with COVID-19
description: All populations of patients admitted with COVID-19 in healthcare institutions involved. No intervention but standard care designed by national guidelines will be provided.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 120 Years
healthy volunteers: No
last name: Norton Perez, MD
role: Study Director
affiliation: Grupo de Investigación de Villavicencio
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.
PMID: 31668196
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.
PMID: 32091533
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. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.
PMID: 32171076
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.
PMID: 32227758
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.
PMID: 32220208
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.
PMID: 32220207
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.
PMID: 32187459
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.
PMID: 32146445
responsible party type: Principal Investigator
investigator affiliation: Hospital Departamental de Villavicencio
investigator full name: Norton Perez-Gutierrez, MD
investigator title: Critical Care Chief of Staff; professor of medicine
mesh term: Pneumonia
mesh term: Severe Acute Respiratory Syndrome
sharing ipd: Undecided
ipd description: Mendeley Data