<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/NCT04481360</url>
  </required_header>
  <id_info>
    <org_study_id>Presentation of COVID19 in AUH</org_study_id>
    <nct_id>NCT04481360</nct_id>
  </id_info>
  <brief_title>Evaluation of Clinical Characteristics and Outcome of COVID19 Pneumonia in Assiut University Hospital</brief_title>
  <official_title>Evaluation of Clinical Characteristics and Outcome of COVID19 Pneumonia in Assiut</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  Evaluation of the clinical presentation of COVID 19 pneumonia.&#xD;
&#xD;
        -  Identification the risk factors of severing COVID 19 pneumonia.&#xD;
&#xD;
        -  Evaluation of the outcome of the disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coronavirus disease 2019 (COVID-19) is defined as illness caused by a novel coronavirus now&#xD;
      called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; formerly called&#xD;
      2019-nCoV), which was first identified amid an outbreak of respiratory illness cases in Wuhan&#xD;
      City, Hubei Province, China. It was initially reported to the WHO on December 31, 2019. On&#xD;
      January 30, 2020, the WHO declared the COVID-19 outbreak a global health emergency.On March&#xD;
      11, 2020, the WHO declared COVID-19 a global pandemic, its first such designation since&#xD;
      declaring H1N1 influenza a pandemic in 2009. The incubation period for coronavirus disease&#xD;
      2019 (COVID-19) is believed to extend to 14 days, with a median time of 4-5 days from&#xD;
      exposure to symptomatic onset. In one study, 97.5% of symptomatic patients developed symptoms&#xD;
      within 11.5 days of becoming infected. Most patients with coronavirus disease 2019 (COVID-19)&#xD;
      will experience the following (in descending frequency): Fever, Cough, Fatigue, Anorexia,&#xD;
      Shortness of breath, Sputum production, Myalgia.&#xD;
&#xD;
      Atypical presentations have been described, and older adults and persons with medical&#xD;
      comorbidities may have delayed presentation of fever and respiratory symptoms.&#xD;
&#xD;
      Less common symptoms (&lt; 10%) include headache, confusion, rhinorrhea, sore throat, and&#xD;
      hemoptysis. Some patients have experienced gastrointestinal symptoms such as diarrhoea and&#xD;
      nausea prior to developing fever and lower respiratory tract signs and symptoms. anosmia may&#xD;
      precede the onset of respiratory symptoms. The most common serious manifestation of COVID-19&#xD;
      upon the initial presentation is pneumonia. Fever, cough, dyspnea, and abnormalities on chest&#xD;
      imaging are common in these cases. Bilateral distribution of ground-glass opacities (GGO)&#xD;
      with or without consolidation in posterior and peripheral lungs was the cardinal hallmark of&#xD;
      COVID-19. However, with further analysis of increasing cases, a diversity of interesting CT&#xD;
      imaging features were found, including crazy paving pattern, airway changes, halo sign,&#xD;
      Pleural changes including pleural thickening and pleural effusion, Vascular enlargement, Air&#xD;
      bubble sign, Lymphadenopathy, etc, which may shed light on the possible mechanism of lung&#xD;
      injury in COVID-19. On the laboratory aspect leukopenia, leukocytosis, and lymphopenia were&#xD;
      common among early cases. Lactate dehydrogenase and ferritin levels are commonly elevated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2020</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">August 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>Clinical evaluation</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Patients assessment using CURB 65|(confusion ,urea level, respiratory rate blood pressure,age above 65 years) score 0 or 1 out patient -2 inpatient observation- 3 or more ICU admission.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Coronavirus</condition>
  <arm_group>
    <arm_group_label>patients with covid 19 pneumonia</arm_group_label>
    <description>clinical presentation &amp; outcome of covid 19 pneumonia</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CT of the chest</intervention_name>
    <description>Degree of affection on the lung infected by COVID19</description>
    <arm_group_label>patients with covid 19 pneumonia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        200 patients diagnosed as COVID19 pneumonia and eligible for search criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with COVID 19 PCR positive&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients less than 18 years of age .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Safaa Mokhtar</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mostafa kamal</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marina Saman</last_name>
    <phone>01204171412</phone>
    <email>marina011335@med.au.edu.eg</email>
  </overall_contact>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 11, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Marina Omil Saman</investigator_full_name>
    <investigator_title>Principle investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
  </condition_browse>
  <!-- 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/NCT04481360
org study id: Presentation of COVID19 in AUH
nct id: NCT04481360
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
-  Evaluation of the clinical presentation of COVID 19 pneumonia.

        -  Identification the risk factors of severing COVID 19 pneumonia.

        -  Evaluation of the outcome of the disease.
Coronavirus disease 2019 (COVID-19) is defined as illness caused by a novel coronavirus now
      called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; formerly called
      2019-nCoV), which was first identified amid an outbreak of respiratory illness cases in Wuhan
      City, Hubei Province, China. It was initially reported to the WHO on December 31, 2019. On
      January 30, 2020, the WHO declared the COVID-19 outbreak a global health emergency.On March
      11, 2020, the WHO declared COVID-19 a global pandemic, its first such designation since
      declaring H1N1 influenza a pandemic in 2009. The incubation period for coronavirus disease
      2019 (COVID-19) is believed to extend to 14 days, with a median time of 4-5 days from
      exposure to symptomatic onset. In one study, 97.5% of symptomatic patients developed symptoms
      within 11.5 days of becoming infected. Most patients with coronavirus disease 2019 (COVID-19)
      will experience the following (in descending frequency): Fever, Cough, Fatigue, Anorexia,
      Shortness of breath, Sputum production, Myalgia.

      Atypical presentations have been described, and older adults and persons with medical
      comorbidities may have delayed presentation of fever and respiratory symptoms.

      Less common symptoms (< 10%) include headache, confusion, rhinorrhea, sore throat, and
      hemoptysis. Some patients have experienced gastrointestinal symptoms such as diarrhoea and
      nausea prior to developing fever and lower respiratory tract signs and symptoms. anosmia may
      precede the onset of respiratory symptoms. The most common serious manifestation of COVID-19
      upon the initial presentation is pneumonia. Fever, cough, dyspnea, and abnormalities on chest
      imaging are common in these cases. Bilateral distribution of ground-glass opacities (GGO)
      with or without consolidation in posterior and peripheral lungs was the cardinal hallmark of
      COVID-19. However, with further analysis of increasing cases, a diversity of interesting CT
      imaging features were found, including crazy paving pattern, airway changes, halo sign,
      Pleural changes including pleural thickening and pleural effusion, Vascular enlargement, Air
      bubble sign, Lymphadenopathy, etc, which may shed light on the possible mechanism of lung
      injury in COVID-19. On the laboratory aspect leukopenia, leukocytosis, and lymphopenia were
      common among early cases. Lactate dehydrogenase and ferritin levels are commonly elevated.
observational model: Cohort
time perspective: Prospective
measure: Clinical evaluation
time frame: through study completion, an average of 1 year
description: Patients assessment using CURB 65|(confusion ,urea level, respiratory rate blood pressure,age above 65 years) score 0 or 1 out patient -2 inpatient observation- 3 or more ICU admission.
arm group label: patients with covid 19 pneumonia
description: clinical presentation & outcome of covid 19 pneumonia
intervention type: Device
intervention name: CT of the chest
description: Degree of affection on the lung infected by COVID19
arm group label: patients with covid 19 pneumonia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Safaa Mokhtar
role: Study Director
affiliation: Assiut University
last name: Mostafa kamal
role: Study Director
affiliation: Assiut University
last name: Marina Saman
phone: 01204171412
email: marina011335@med.au.edu.eg
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Marina Omil Saman
investigator title: Principle investigator
mesh term: Pneumonia