<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/NCT04497311</url>
  </required_header>
  <id_info>
    <org_study_id>HGL-ENSE-00743-20</org_study_id>
    <nct_id>NCT04497311</nct_id>
  </id_info>
  <brief_title>Tomographic Findings in COVID-19 and Influenza</brief_title>
  <acronym>TOMOCOVIDMX</acronym>
  <official_title>Pulmonary Tomographic Findings in COVID-19 and Influenza H1N1 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Guanajuato</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital General Regional de León</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Medical Center Groningen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad de Guanajuato</source>
  <oversight_info>
    <has_dmc>No</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>
      The investigators decided to conduct a longitudinal study that compares the pulmonary&#xD;
      tomographic patterns found in patients with viral pneumonia (i.e. influenza H1N1 and&#xD;
      SARS-CoV-2) at a regional hospital. The primary aim of this study is to compare the&#xD;
      radiological patterns found in patients with COVID-19 and influenza H1N1. The secondary aims&#xD;
      of this study will assess the association between the radiological CT pattern and the need&#xD;
      for invasive mechanical ventilation and mortality within the first 28 days of intensive care&#xD;
      unit admission.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background&#xD;
&#xD;
      In late 2019, a new coronavirus was linked to several cases of pneumonia in the city of&#xD;
      Wuhan, Hubei province, China. On February 11, 2020, the World Health Organization (WHO)&#xD;
      designated COVID-19 a pandemic disease. The mortality associated with COVID-19 patients that&#xD;
      required management in a critical care unit is approximately 4.3%. COVID-19 is caused by&#xD;
      severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Diagnosis of COVID-19 is made&#xD;
      with a positive test (i.e. reverse transcriptase-polymerase chain reaction, RT-PCR) from a&#xD;
      person with clinical signs and symptoms of a respiratory tract infection. Viral pneumonia is&#xD;
      currently a challenge worldwide as it is associated with high morbidity and mortality. In&#xD;
      June of 2009, the WHO declared influenza A H1N1 a pandemic disease. Worldwide, influenza H1N1&#xD;
      had a mortality of 11%, with a higher mortality rate among people older than 50 years of age&#xD;
      (i.e. 18-20%). Influenza diagnosis can be established using RT-PCR. Around 200 million cases&#xD;
      of community-acquired viral pneumonia occur each year worldwide, 100 million in children, and&#xD;
      100 million in adults. Imaging findings in viral pneumonia are diverse and overlap with&#xD;
      findings associated with non-viral infections and inflammatory conditions. However,&#xD;
      identifying the underlying viral pathogens may not always be easy. Several imaging patterns&#xD;
      have been described in association with these viruses. Although a definitive diagnosis cannot&#xD;
      be achieved based on imaging studies, imaging pattern recognition of viral pneumonia can help&#xD;
      differentiate between viral and bacterial pathogens; thus, reducing the use of indiscriminate&#xD;
      antibiotics. There are few studies that correlate tomographic findings in patients with viral&#xD;
      infections in the lower respiratory tract.&#xD;
&#xD;
      The use of computed tomography (CT) should be considered as the first option for diagnostic&#xD;
      imaging in patients with suspected pneumonia. Peripheral multifocal ground glass patterns&#xD;
      with irregular consolidation images found in the lower lobes or posteriorly in pulmonary CT&#xD;
      scans have been described in patients with viral pneumonia due to SARS-CoV-2. Furthermore,&#xD;
      complicating the diagnosis of atypical viral pneumonia, 17.9% of mild COVID-19 and 2.9% of&#xD;
      moderate-severe COVID-19 patients did not have CT evidence of pneumonia upon hospital&#xD;
      admission. One recent study compared the CT radiological patterns found in COVID-19 pneumonia&#xD;
      to other viral pneumonias (i.e. influenza, parainfluenza, adenovirus, and respiratory&#xD;
      syncytial virus) reporting higher peripheral distribution (i.e. 80% vs. 57%, p&lt;0.001), more&#xD;
      ground-glass opacities (i.e. 91% vs 68%, p&lt;0.001), greater frequency of fine reticular&#xD;
      opacities (i.e. 56% vs. 22%, p&lt;0.001), and vascular thickening in COVID-19 patients;&#xD;
      meanwhile, other viral pneumonias were more likely to have a mixed distribution pattern(i.e.&#xD;
      35% vs. 14%, p&lt;0.001), have pleural effusion (i.e. 39% vs. 4.1%, p&lt;0.001), and present&#xD;
      visible lymph nodes (10.2% vs. 2.7%, p&lt;0.001). Another study compared the pulmonary&#xD;
      radiological patterns associated with COVID-19 compared to influenza (A and B) reporting&#xD;
      higher round opacities (i.e. 35% vs. 17%, p=0.048) and greater frequency of interlobular&#xD;
      septal thickening (i.e. 66% vs. 43%, p=0.014) in patients with COVID-19; conversely,&#xD;
      influenza patients had a higher frequency of nodular lesions (i.e. 71% vs. 28%, p&lt;0.001),&#xD;
      higher frequency of small dense nodular lesions (i.e. 40% vs. 9%, p&lt;0.001), and more likely&#xD;
      to have pleural effusion (i.e. 31% vs. 6%, p&lt;0.001).&#xD;
&#xD;
      Research questions&#xD;
&#xD;
        1. What are the pulmonary tomographic findings in patients diagnosed with&#xD;
           community-acquired pneumonia secondary to SARS-CoV-2?&#xD;
&#xD;
        2. What are the pulmonary tomographic findings in patients diagnosed with&#xD;
           community-acquired pneumonia secondary to H1N1 influenza?&#xD;
&#xD;
        3. Are the 28-day survival distributions different for SARS-CoV-2 and H1N1 influenza?&#xD;
&#xD;
        4. Is there a difference in the 28-day survival distribution and the pulmonary tomographic&#xD;
           radiological patterns in patients with pneumonia secondary to SARS-CoV-2?&#xD;
&#xD;
        5. Is there a difference in the 28-day survival distribution and the pulmonary tomographic&#xD;
           radiological patterns in patients with pneumonia secondary to H1N1 influenza?&#xD;
&#xD;
        6. What factors are associated with the survival differences in 28-day mortality in both&#xD;
           groups and between groups?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Anticipated">April 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Radiological findings</measure>
    <time_frame>24 hours</time_frame>
    <description>Lung CT radiological patterns associated with COVID-19 or Influenza H1N1</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>28 days</time_frame>
    <description>Intrahospital and overall survival at 28 days from hospital admission.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>SARS-CoV-2</condition>
  <condition>Covid19</condition>
  <condition>H1N1 Influenza</condition>
  <condition>Computed Tomography</condition>
  <arm_group>
    <arm_group_label>SARS-CoV-2</arm_group_label>
    <description>Patients with a SARS-CoV-2 polymerase chain reaction positive test upon admission to the emergency department.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>H1N1 influenza</arm_group_label>
    <description>Patients with an influenza H1N1 polymerase chain reaction positive test upon admission to the emergency department.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Thoraxic computed tomography</intervention_name>
    <description>Diagnostic lung CT.</description>
    <arm_group_label>H1N1 influenza</arm_group_label>
    <arm_group_label>SARS-CoV-2</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Nasopharyngeal (NP) specimen, oropharyngeal (OP) specimen, nasal mid-turbinate swab, anterior&#xD;
      nares (nasal swab) specimen, nasopharyngeal wash/aspirate or nasal wash/aspirate (NW)&#xD;
      specimen or sputum from upper airways.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Convenience sample from a Mexican urban, suburban, and rural population. The patients come&#xD;
        from all demographical and socio-economic strata from a country with a high (0.767) Human&#xD;
        Development Index. Our hospital is open to the entire population and primarily assists&#xD;
        people with limited to very limited resources.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with signed informed consent.&#xD;
&#xD;
          -  Patients with a positive PCR test for SARS-CoV-2 or influenza H1N1 test upon emergency&#xD;
             department admission.&#xD;
&#xD;
          -  Patients with lung CT within 24hrs of specimen collection for PCR test.&#xD;
&#xD;
          -  Patients with complete 30-day follow-up information.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are unwilling to undergo a lung CT.&#xD;
&#xD;
          -  Negative PCR test for SARS-CoV-2 or influenza H1N1 test upon emergency department&#xD;
             admission.&#xD;
&#xD;
          -  Patients with a tumor or tumor metastasis on the pulmonary CT.&#xD;
&#xD;
          -  Patients with a previous or de novo autoimmune disease diagnosis.&#xD;
&#xD;
          -  Patients with a previous or de novo interstitial lung disease.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
        Elimination Criteria:&#xD;
&#xD;
          -  Patients with loss of information on the variables of interest.&#xD;
&#xD;
          -  Patients without 30-day follow-up information.&#xD;
&#xD;
          -  Patients who chose to withdraw their participation at any time of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Omar Jiménez-Zarazúa, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical researcher, Internist</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lourdes N Vélez-Ramírez, M.D.</last_name>
    <phone>+52 477 719 7400</phone>
    <email>nestlynoemi@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Omar Jiménez-Zarazúa, M.D.</last_name>
    <phone>+52 4421377672</phone>
    <email>drzarazuainterna@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital General León-Milenio</name>
      <address>
        <city>León</city>
        <state>Guanajuato</state>
        <zip>37672</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lourdes N Veléz-Ramírez, M.D.</last_name>
      <phone>+52 477 719 7400</phone>
      <email>nestlynoemi@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Omar Jiménez-Zarazúa, M.D.</last_name>
      <phone>+52 4421377672</phone>
      <email>drzarazuainterna@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <results_reference>
    <citation>Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum In: JAMA. 2021 Mar 16;325(11):1113.</citation>
    <PMID>32031570</PMID>
  </results_reference>
  <results_reference>
    <citation>Dandachi D, Rodriguez-Barradas MC. Viral pneumonia: etiologies and treatment. J Investig Med. 2018 Aug;66(6):957-965. doi: 10.1136/jim-2018-000712. Epub 2018 Apr 20.</citation>
    <PMID>29680828</PMID>
  </results_reference>
  <results_reference>
    <citation>Fineberg HV. Pandemic preparedness and response--lessons from the H1N1 influenza of 2009. N Engl J Med. 2014 Apr 3;370(14):1335-42. doi: 10.1056/NEJMra1208802. No abstract available. Erratum In: N Engl J Med. 2015 Jan 8;372(2):197.</citation>
    <PMID>24693893</PMID>
  </results_reference>
  <results_reference>
    <citation>Louie JK, Acosta M, Winter K, Jean C, Gavali S, Schechter R, Vugia D, Harriman K, Matyas B, Glaser CA, Samuel MC, Rosenberg J, Talarico J, Hatch D; California Pandemic (H1N1) Working Group. Factors associated with death or hospitalization due to pandemic 2009 influenza A(H1N1) infection in California. JAMA. 2009 Nov 4;302(17):1896-902. doi: 10.1001/jama.2009.1583.</citation>
    <PMID>19887665</PMID>
  </results_reference>
  <results_reference>
    <citation>Uyeki TM, Bernstein HH, Bradley JS, Englund JA, File TM, Fry AM, Gravenstein S, Hayden FG, Harper SA, Hirshon JM, Ison MG, Johnston BL, Knight SL, McGeer A, Riley LE, Wolfe CR, Alexander PE, Pavia AT. Clinical Practice Guidelines by the Infectious Diseases Society of America: 2018 Update on Diagnosis, Treatment, Chemoprophylaxis, and Institutional Outbreak Management of Seasonal Influenzaa. Clin Infect Dis. 2019 Mar 5;68(6):e1-e47. doi: 10.1093/cid/ciy866. Erratum In: Clin Infect Dis. 2019 May 2;68(10):1790.</citation>
    <PMID>30566567</PMID>
  </results_reference>
  <results_reference>
    <citation>Ruuskanen O, Lahti E, Jennings LC, Murdoch DR. Viral pneumonia. Lancet. 2011 Apr 9;377(9773):1264-75. doi: 10.1016/S0140-6736(10)61459-6. Epub 2011 Mar 22.</citation>
    <PMID>21435708</PMID>
  </results_reference>
  <results_reference>
    <citation>Koo HJ, Lim S, Choe J, Choi SH, Sung H, Do KH. Radiographic and CT Features of Viral Pneumonia. Radiographics. 2018 May-Jun;38(3):719-739. doi: 10.1148/rg.2018170048.</citation>
    <PMID>29757717</PMID>
  </results_reference>
  <results_reference>
    <citation>Shiley KT, Van Deerlin VM, Miller WT Jr. Chest CT features of community-acquired respiratory viral infections in adult inpatients with lower respiratory tract infections. J Thorac Imaging. 2010 Feb;25(1):68-75. doi: 10.1097/RTI.0b013e3181b0ba8b.</citation>
    <PMID>20160606</PMID>
  </results_reference>
  <results_reference>
    <citation>Upchurch CP, Grijalva CG, Wunderink RG, Williams DJ, Waterer GW, Anderson EJ, Zhu Y, Hart EM, Carroll F, Bramley AM, Jain S, Edwards KM, Self WH. Community-Acquired Pneumonia Visualized on CT Scans but Not Chest Radiographs: Pathogens, Severity, and Clinical Outcomes. Chest. 2018 Mar;153(3):601-610. doi: 10.1016/j.chest.2017.07.035. Epub 2017 Aug 9.</citation>
    <PMID>28802696</PMID>
  </results_reference>
  <results_reference>
    <citation>Zu ZY, Jiang MD, Xu PP, Chen W, Ni QQ, Lu GM, Zhang LJ. Coronavirus Disease 2019 (COVID-19): A Perspective from China. Radiology. 2020 Aug;296(2):E15-E25. doi: 10.1148/radiol.2020200490. Epub 2020 Feb 21.</citation>
    <PMID>32083985</PMID>
  </results_reference>
  <results_reference>
    <citation>Bai HX, Hsieh B, Xiong Z, Halsey K, Choi JW, Tran TML, Pan I, Shi LB, Wang DC, Mei J, Jiang XL, Zeng QH, Egglin TK, Hu PF, Agarwal S, Xie FF, Li S, Healey T, Atalay MK, Liao WH. Performance of Radiologists in Differentiating COVID-19 from Non-COVID-19 Viral Pneumonia at Chest CT. Radiology. 2020 Aug;296(2):E46-E54. doi: 10.1148/radiol.2020200823. Epub 2020 Mar 10.</citation>
    <PMID>32155105</PMID>
  </results_reference>
  <results_reference>
    <citation>Liu M, Zeng W, Wen Y, Zheng Y, Lv F, Xiao K. COVID-19 pneumonia: CT findings of 122 patients and differentiation from influenza pneumonia. Eur Radiol. 2020 Oct;30(10):5463-5469. doi: 10.1007/s00330-020-06928-0. Epub 2020 May 12.</citation>
    <PMID>32399710</PMID>
  </results_reference>
  <results_reference>
    <citation>Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.</citation>
    <PMID>32109013</PMID>
  </results_reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Guanajuato</investigator_affiliation>
    <investigator_full_name>Jaime Daniel Mondragón Uribe</investigator_full_name>
    <investigator_title>Medical researcher</investigator_title>
  </responsible_party>
  <keyword>Radiological patterns</keyword>
  <keyword>28-day survival</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>A database will be generated and available upon request. All patients will de unidentified.</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/NCT04497311
org study id: HGL-ENSE-00743-20
nct id: NCT04497311
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators decided to conduct a longitudinal study that compares the pulmonary
      tomographic patterns found in patients with viral pneumonia (i.e. influenza H1N1 and
      SARS-CoV-2) at a regional hospital. The primary aim of this study is to compare the
      radiological patterns found in patients with COVID-19 and influenza H1N1. The secondary aims
      of this study will assess the association between the radiological CT pattern and the need
      for invasive mechanical ventilation and mortality within the first 28 days of intensive care
      unit admission.
Background

      In late 2019, a new coronavirus was linked to several cases of pneumonia in the city of
      Wuhan, Hubei province, China. On February 11, 2020, the World Health Organization (WHO)
      designated COVID-19 a pandemic disease. The mortality associated with COVID-19 patients that
      required management in a critical care unit is approximately 4.3%. COVID-19 is caused by
      severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Diagnosis of COVID-19 is made
      with a positive test (i.e. reverse transcriptase-polymerase chain reaction, RT-PCR) from a
      person with clinical signs and symptoms of a respiratory tract infection. Viral pneumonia is
      currently a challenge worldwide as it is associated with high morbidity and mortality. In
      June of 2009, the WHO declared influenza A H1N1 a pandemic disease. Worldwide, influenza H1N1
      had a mortality of 11%, with a higher mortality rate among people older than 50 years of age
      (i.e. 18-20%). Influenza diagnosis can be established using RT-PCR. Around 200 million cases
      of community-acquired viral pneumonia occur each year worldwide, 100 million in children, and
      100 million in adults. Imaging findings in viral pneumonia are diverse and overlap with
      findings associated with non-viral infections and inflammatory conditions. However,
      identifying the underlying viral pathogens may not always be easy. Several imaging patterns
      have been described in association with these viruses. Although a definitive diagnosis cannot
      be achieved based on imaging studies, imaging pattern recognition of viral pneumonia can help
      differentiate between viral and bacterial pathogens; thus, reducing the use of indiscriminate
      antibiotics. There are few studies that correlate tomographic findings in patients with viral
      infections in the lower respiratory tract.

      The use of computed tomography (CT) should be considered as the first option for diagnostic
      imaging in patients with suspected pneumonia. Peripheral multifocal ground glass patterns
      with irregular consolidation images found in the lower lobes or posteriorly in pulmonary CT
      scans have been described in patients with viral pneumonia due to SARS-CoV-2. Furthermore,
      complicating the diagnosis of atypical viral pneumonia, 17.9% of mild COVID-19 and 2.9% of
      moderate-severe COVID-19 patients did not have CT evidence of pneumonia upon hospital
      admission. One recent study compared the CT radiological patterns found in COVID-19 pneumonia
      to other viral pneumonias (i.e. influenza, parainfluenza, adenovirus, and respiratory
      syncytial virus) reporting higher peripheral distribution (i.e. 80% vs. 57%, p<0.001), more
      ground-glass opacities (i.e. 91% vs 68%, p<0.001), greater frequency of fine reticular
      opacities (i.e. 56% vs. 22%, p<0.001), and vascular thickening in COVID-19 patients;
      meanwhile, other viral pneumonias were more likely to have a mixed distribution pattern(i.e.
      35% vs. 14%, p<0.001), have pleural effusion (i.e. 39% vs. 4.1%, p<0.001), and present
      visible lymph nodes (10.2% vs. 2.7%, p<0.001). Another study compared the pulmonary
      radiological patterns associated with COVID-19 compared to influenza (A and B) reporting
      higher round opacities (i.e. 35% vs. 17%, p=0.048) and greater frequency of interlobular
      septal thickening (i.e. 66% vs. 43%, p=0.014) in patients with COVID-19; conversely,
      influenza patients had a higher frequency of nodular lesions (i.e. 71% vs. 28%, p<0.001),
      higher frequency of small dense nodular lesions (i.e. 40% vs. 9%, p<0.001), and more likely
      to have pleural effusion (i.e. 31% vs. 6%, p<0.001).

      Research questions

        1. What are the pulmonary tomographic findings in patients diagnosed with
           community-acquired pneumonia secondary to SARS-CoV-2?

        2. What are the pulmonary tomographic findings in patients diagnosed with
           community-acquired pneumonia secondary to H1N1 influenza?

        3. Are the 28-day survival distributions different for SARS-CoV-2 and H1N1 influenza?

        4. Is there a difference in the 28-day survival distribution and the pulmonary tomographic
           radiological patterns in patients with pneumonia secondary to SARS-CoV-2?

        5. Is there a difference in the 28-day survival distribution and the pulmonary tomographic
           radiological patterns in patients with pneumonia secondary to H1N1 influenza?

        6. What factors are associated with the survival differences in 28-day mortality in both
           groups and between groups?
observational model: Cohort
time perspective: Prospective
measure: Radiological findings
time frame: 24 hours
description: Lung CT radiological patterns associated with COVID-19 or Influenza H1N1
measure: Survival
time frame: 28 days
description: Intrahospital and overall survival at 28 days from hospital admission.
arm group label: SARS-CoV-2
description: Patients with a SARS-CoV-2 polymerase chain reaction positive test upon admission to the emergency department.
arm group label: H1N1 influenza
description: Patients with an influenza H1N1 polymerase chain reaction positive test upon admission to the emergency department.
intervention type: Diagnostic Test
intervention name: Thoraxic computed tomography
description: Diagnostic lung CT.
arm group label: H1N1 influenza
arm group label: SARS-CoV-2
Nasopharyngeal (NP) specimen, oropharyngeal (OP) specimen, nasal mid-turbinate swab, anterior
      nares (nasal swab) specimen, nasopharyngeal wash/aspirate or nasal wash/aspirate (NW)
      specimen or sputum from upper airways.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Omar Jiménez-Zarazúa, M.D.
role: Principal Investigator
affiliation: Medical researcher, Internist
last name: Lourdes N Vélez-Ramírez, M.D.
phone: +52 477 719 7400
email: nestlynoemi@gmail.com
last name: Omar Jiménez-Zarazúa, M.D.
phone: +52 4421377672
email: drzarazuainterna@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Mexico
citation: Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum In: JAMA. 2021 Mar 16;325(11):1113.
PMID: 32031570
citation: Dandachi D, Rodriguez-Barradas MC. Viral pneumonia: etiologies and treatment. J Investig Med. 2018 Aug;66(6):957-965. doi: 10.1136/jim-2018-000712. Epub 2018 Apr 20.
PMID: 29680828
citation: Fineberg HV. Pandemic preparedness and response--lessons from the H1N1 influenza of 2009. N Engl J Med. 2014 Apr 3;370(14):1335-42. doi: 10.1056/NEJMra1208802. No abstract available. Erratum In: N Engl J Med. 2015 Jan 8;372(2):197.
PMID: 24693893
citation: Louie JK, Acosta M, Winter K, Jean C, Gavali S, Schechter R, Vugia D, Harriman K, Matyas B, Glaser CA, Samuel MC, Rosenberg J, Talarico J, Hatch D; California Pandemic (H1N1) Working Group. Factors associated with death or hospitalization due to pandemic 2009 influenza A(H1N1) infection in California. JAMA. 2009 Nov 4;302(17):1896-902. doi: 10.1001/jama.2009.1583.
PMID: 19887665
citation: Uyeki TM, Bernstein HH, Bradley JS, Englund JA, File TM, Fry AM, Gravenstein S, Hayden FG, Harper SA, Hirshon JM, Ison MG, Johnston BL, Knight SL, McGeer A, Riley LE, Wolfe CR, Alexander PE, Pavia AT. Clinical Practice Guidelines by the Infectious Diseases Society of America: 2018 Update on Diagnosis, Treatment, Chemoprophylaxis, and Institutional Outbreak Management of Seasonal Influenzaa. Clin Infect Dis. 2019 Mar 5;68(6):e1-e47. doi: 10.1093/cid/ciy866. Erratum In: Clin Infect Dis. 2019 May 2;68(10):1790.
PMID: 30566567
citation: Ruuskanen O, Lahti E, Jennings LC, Murdoch DR. Viral pneumonia. Lancet. 2011 Apr 9;377(9773):1264-75. doi: 10.1016/S0140-6736(10)61459-6. Epub 2011 Mar 22.
PMID: 21435708
citation: Koo HJ, Lim S, Choe J, Choi SH, Sung H, Do KH. Radiographic and CT Features of Viral Pneumonia. Radiographics. 2018 May-Jun;38(3):719-739. doi: 10.1148/rg.2018170048.
PMID: 29757717
citation: Shiley KT, Van Deerlin VM, Miller WT Jr. Chest CT features of community-acquired respiratory viral infections in adult inpatients with lower respiratory tract infections. J Thorac Imaging. 2010 Feb;25(1):68-75. doi: 10.1097/RTI.0b013e3181b0ba8b.
PMID: 20160606
citation: Upchurch CP, Grijalva CG, Wunderink RG, Williams DJ, Waterer GW, Anderson EJ, Zhu Y, Hart EM, Carroll F, Bramley AM, Jain S, Edwards KM, Self WH. Community-Acquired Pneumonia Visualized on CT Scans but Not Chest Radiographs: Pathogens, Severity, and Clinical Outcomes. Chest. 2018 Mar;153(3):601-610. doi: 10.1016/j.chest.2017.07.035. Epub 2017 Aug 9.
PMID: 28802696
citation: Zu ZY, Jiang MD, Xu PP, Chen W, Ni QQ, Lu GM, Zhang LJ. Coronavirus Disease 2019 (COVID-19): A Perspective from China. Radiology. 2020 Aug;296(2):E15-E25. doi: 10.1148/radiol.2020200490. Epub 2020 Feb 21.
PMID: 32083985
citation: Bai HX, Hsieh B, Xiong Z, Halsey K, Choi JW, Tran TML, Pan I, Shi LB, Wang DC, Mei J, Jiang XL, Zeng QH, Egglin TK, Hu PF, Agarwal S, Xie FF, Li S, Healey T, Atalay MK, Liao WH. Performance of Radiologists in Differentiating COVID-19 from Non-COVID-19 Viral Pneumonia at Chest CT. Radiology. 2020 Aug;296(2):E46-E54. doi: 10.1148/radiol.2020200823. Epub 2020 Mar 10.
PMID: 32155105
citation: Liu M, Zeng W, Wen Y, Zheng Y, Lv F, Xiao K. COVID-19 pneumonia: CT findings of 122 patients and differentiation from influenza pneumonia. Eur Radiol. 2020 Oct;30(10):5463-5469. doi: 10.1007/s00330-020-06928-0. Epub 2020 May 12.
PMID: 32399710
citation: Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
PMID: 32109013
responsible party type: Principal Investigator
investigator affiliation: Universidad de Guanajuato
investigator full name: Jaime Daniel Mondragón Uribe
investigator title: Medical researcher
mesh term: COVID-19
mesh term: Influenza, Human
sharing ipd: Undecided
ipd description: A database will be generated and available upon request. All patients will de unidentified.