<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/NCT04459390</url>
  </required_header>
  <id_info>
    <org_study_id>COVID19</org_study_id>
    <nct_id>NCT04459390</nct_id>
  </id_info>
  <brief_title>Association of Comorbidities With COVID19</brief_title>
  <official_title>Impact of Comorbidities on COVID19 Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Association of Comorbidities with unfavorable COVID19 outcomes as admission to intensive&#xD;
      care, invasive ventilation or death.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COVID19 is a new emerging, rapidly disseminating disease that consuming most of resources of&#xD;
      efficient healthcare systems, and several hospitals, worldwide, are currently experiencing a&#xD;
      shortage of ICU beds for critically ill patients with COVID-19 pneumonia.&#xD;
&#xD;
      A risk stratification based on clinical, radiological and laboratory parameters seems&#xD;
      necessary in order to better identify those patients who may need hospital and/or ICU&#xD;
      admission.&#xD;
&#xD;
      One of the most alarming clinical parameters in general is the presence comorbidities. The&#xD;
      underlying diseases including hypertension, diabetes mellitus, respiratory system disease and&#xD;
      cardiovascular disease, may be risk factors for severe COVID-19 patients with adverse&#xD;
      outcomes compared with non-severe patients. Obesity is also a risk factor for COVID-19&#xD;
      severity with increased need to mechanical ventilation.&#xD;
&#xD;
      Chronic diseases share several features with infectious disorders, such as the&#xD;
      proinflammatory state, and the attenuation of the innate immune response which may be linked&#xD;
      etiologically to its pathogenesis.&#xD;
&#xD;
      Aim of the study:to assess the impact of comorbidities in patients with diagnosis of Covid-19&#xD;
      on outcome, in order to find the predictors of prolonged hospital stay, need for ICU&#xD;
      admission or poor outcome&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Anticipated">November 20, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 20, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of recovery/ ICU admission/ need for mechanical ventilation</measure>
    <time_frame>Baseline</time_frame>
    <description>The mean rate of recovery in patients with diagnosis of Covid19, who present with comorbidities at the time of hospital admission, with the mean recovery rate in patients without any of these comorbidities.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to improvement</measure>
    <time_frame>Baseline</time_frame>
    <description>Comparison of the survival curves (times to improvement) in the two groups (patients with and without comorbidities) and among patients presenting with different types of comorbidities.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>COVID19</condition>
  <arm_group>
    <arm_group_label>COVID19 with comorbidities</arm_group_label>
    <description>Patients with COVID19 with at least one of the following comorbidities:&#xD;
Hypertension&#xD;
Diabetes&#xD;
Cardiovascular disease&#xD;
Chronic pulmonary disease&#xD;
Obesity&#xD;
Chronic liver disease&#xD;
Chronic kidney disease&#xD;
Collagen vascular disease&#xD;
Autoimmune disease&#xD;
Malignancy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COVID19 without comorbidities</arm_group_label>
    <description>Patients with COVID19 without any of the previously mentioned comorbidities</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>realtime PCR</intervention_name>
    <description>Detection of SARS-CoV-2 genes by realtime PCR</description>
    <arm_group_label>COVID19 with comorbidities</arm_group_label>
    <arm_group_label>COVID19 without comorbidities</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      For initial diagnostic testing for SARS-CoV-2, CDC recommends collecting and testing an upper&#xD;
      respiratory specimen. The following are acceptable specimens:&#xD;
&#xD;
        -  A nasopharyngeal (NP) specimen collected by a healthcare provider; or&#xD;
&#xD;
        -  An oropharyngeal (OP) specimen collected by a healthcare provider; or&#xD;
&#xD;
        -  Sputum specimen collected by a healthcare provider. Swab specimens should be collected&#xD;
           using only swabs with a synthetic tip, and an aluminum or plastic shaft. Place swabs&#xD;
           immediately into sterile tubes containing 2-3 mL of viral transport media. Store the&#xD;
           samples at 2-8°C up to 72 hours. If a delay in shipping or extraction is expected, store&#xD;
           samples at -70°C in accordance with CDC's protocol.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Study population: Patients admitted to Assiut university Hospitals diagnosed as COVID19&#xD;
        positive patients by PCR. All patients will be subjected to full clinical assessment, some&#xD;
        laboratory investigations which are potential marker of disease severity.&#xD;
&#xD;
        Another studies include chest X ray and CT chest.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Covid-19 test positive; hospitalized subjects; both sexes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no exclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hebatallah Hassan</last_name>
    <phone>01022182086</phone>
    <email>heba.ismailhassan@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculty of Medicine</name>
      <address>
        <city>Assiut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Yang J, Zheng Y, Gou X, Pu K, Chen Z, Guo Q, Ji R, Wang H, Wang Y, Zhou Y. Prevalence of comorbidities and its effects in patients infected with SARS-CoV-2: a systematic review and meta-analysis. Int J Infect Dis. 2020 May;94:91-95. doi: 10.1016/j.ijid.2020.03.017. Epub 2020 Mar 12.</citation>
    <PMID>32173574</PMID>
  </reference>
  <reference>
    <citation>Simonnet A, Chetboun M, Poissy J, Raverdy V, Noulette J, Duhamel A, Labreuche J, Mathieu D, Pattou F, Jourdain M; LICORN and the Lille COVID-19 and Obesity study group. High Prevalence of Obesity in Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Requiring Invasive Mechanical Ventilation. Obesity (Silver Spring). 2020 Jul;28(7):1195-1199. doi: 10.1002/oby.22831. Epub 2020 Jun 10. Erratum In: Obesity (Silver Spring). 2020 Oct;28(10):1994.</citation>
    <PMID>32271993</PMID>
  </reference>
  <reference>
    <citation>Badawi A, Ryoo SG. Prevalence of comorbidities in the Middle East respiratory syndrome coronavirus (MERS-CoV): a systematic review and meta-analysis. Int J Infect Dis. 2016 Aug;49:129-33. doi: 10.1016/j.ijid.2016.06.015. Epub 2016 Jun 21.</citation>
    <PMID>27352628</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 5, 2020</study_first_submitted>
  <study_first_submitted_qc>July 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 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>Assiut University</investigator_affiliation>
    <investigator_full_name>Hebatallah Hassan</investigator_full_name>
    <investigator_title>dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT04459390
org study id: COVID19
nct id: NCT04459390
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Association of Comorbidities with unfavorable COVID19 outcomes as admission to intensive
      care, invasive ventilation or death.
COVID19 is a new emerging, rapidly disseminating disease that consuming most of resources of
      efficient healthcare systems, and several hospitals, worldwide, are currently experiencing a
      shortage of ICU beds for critically ill patients with COVID-19 pneumonia.

      A risk stratification based on clinical, radiological and laboratory parameters seems
      necessary in order to better identify those patients who may need hospital and/or ICU
      admission.

      One of the most alarming clinical parameters in general is the presence comorbidities. The
      underlying diseases including hypertension, diabetes mellitus, respiratory system disease and
      cardiovascular disease, may be risk factors for severe COVID-19 patients with adverse
      outcomes compared with non-severe patients. Obesity is also a risk factor for COVID-19
      severity with increased need to mechanical ventilation.

      Chronic diseases share several features with infectious disorders, such as the
      proinflammatory state, and the attenuation of the innate immune response which may be linked
      etiologically to its pathogenesis.

      Aim of the study:to assess the impact of comorbidities in patients with diagnosis of Covid-19
      on outcome, in order to find the predictors of prolonged hospital stay, need for ICU
      admission or poor outcome
observational model: Case-Control
time perspective: Prospective
measure: Rate of recovery/ ICU admission/ need for mechanical ventilation
time frame: Baseline
description: The mean rate of recovery in patients with diagnosis of Covid19, who present with comorbidities at the time of hospital admission, with the mean recovery rate in patients without any of these comorbidities.
measure: Time to improvement
time frame: Baseline
description: Comparison of the survival curves (times to improvement) in the two groups (patients with and without comorbidities) and among patients presenting with different types of comorbidities.
arm group label: COVID19 with comorbidities
description: Patients with COVID19 with at least one of the following comorbidities:
Hypertension
Diabetes
Cardiovascular disease
Chronic pulmonary disease
Obesity
Chronic liver disease
Chronic kidney disease
Collagen vascular disease
Autoimmune disease
Malignancy
arm group label: COVID19 without comorbidities
description: Patients with COVID19 without any of the previously mentioned comorbidities
intervention type: Diagnostic Test
intervention name: realtime PCR
description: Detection of SARS-CoV-2 genes by realtime PCR
arm group label: COVID19 with comorbidities
arm group label: COVID19 without comorbidities
For initial diagnostic testing for SARS-CoV-2, CDC recommends collecting and testing an upper
      respiratory specimen. The following are acceptable specimens:

        -  A nasopharyngeal (NP) specimen collected by a healthcare provider; or

        -  An oropharyngeal (OP) specimen collected by a healthcare provider; or

        -  Sputum specimen collected by a healthcare provider. Swab specimens should be collected
           using only swabs with a synthetic tip, and an aluminum or plastic shaft. Place swabs
           immediately into sterile tubes containing 2-3 mL of viral transport media. Store the
           samples at 2-8°C up to 72 hours. If a delay in shipping or extraction is expected, store
           samples at -70°C in accordance with CDC's protocol.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Hebatallah Hassan
phone: 01022182086
email: heba.ismailhassan@gmail.com
facility: 
status: Recruiting
country: Egypt
citation: Yang J, Zheng Y, Gou X, Pu K, Chen Z, Guo Q, Ji R, Wang H, Wang Y, Zhou Y. Prevalence of comorbidities and its effects in patients infected with SARS-CoV-2: a systematic review and meta-analysis. Int J Infect Dis. 2020 May;94:91-95. doi: 10.1016/j.ijid.2020.03.017. Epub 2020 Mar 12.
PMID: 32173574
citation: Simonnet A, Chetboun M, Poissy J, Raverdy V, Noulette J, Duhamel A, Labreuche J, Mathieu D, Pattou F, Jourdain M; LICORN and the Lille COVID-19 and Obesity study group. High Prevalence of Obesity in Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Requiring Invasive Mechanical Ventilation. Obesity (Silver Spring). 2020 Jul;28(7):1195-1199. doi: 10.1002/oby.22831. Epub 2020 Jun 10. Erratum In: Obesity (Silver Spring). 2020 Oct;28(10):1994.
PMID: 32271993
citation: Badawi A, Ryoo SG. Prevalence of comorbidities in the Middle East respiratory syndrome coronavirus (MERS-CoV): a systematic review and meta-analysis. Int J Infect Dis. 2016 Aug;49:129-33. doi: 10.1016/j.ijid.2016.06.015. Epub 2016 Jun 21.
PMID: 27352628
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Hebatallah Hassan
investigator title: dr
mesh term: COVID-19
sharing ipd: Undecided