<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/NCT04484597</url>
  </required_header>
  <id_info>
    <org_study_id>Prof. Refat Sadeq</org_study_id>
    <nct_id>NCT04484597</nct_id>
  </id_info>
  <brief_title>Predictors of COVID-19 Infection and Disease Progression</brief_title>
  <acronym>Portsaiduni</acronym>
  <official_title>Predictors of COVID-19 Infection and Disease Progression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Port Said University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Port Said University</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>
      Clinical Picture: Symptomatic COVID-19 presents with a recognizable clinical syndrome that is&#xD;
      predictable prior to testing. Clinical judgement remains important, particularly when&#xD;
      interpreting negative test results; 2. Biomarkers Associated with COVID-19 Patients: The most&#xD;
      common laboratory features reported in patients with COVID-19&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The COVID-19 pandemic put tremendous pressures on the public health system and the health&#xD;
      workers in almost every country around the world. Egypt was no exception, one of the main&#xD;
      challenges faced is the limited number of CPR centers, equipment and kits which consequently&#xD;
      affecting the number of tests that could be performed.&#xD;
&#xD;
      Although testing is critical, clinical judgement is the first mean to evaluate patients for&#xD;
      COVID-19. Ancillary Diagnostic Tests and Chest imaging are also important tools before&#xD;
      proceeding to the PCR testing. However, important gaps remain in screening asymptomatic&#xD;
      persons in the incubation phase, as well as in the accurate determination of live viral&#xD;
      shedding during convalescence to inform decisions to end isolation. The main objectives of&#xD;
      the study: To set an evidence-based protocol with some criteria and procedures to reach - as&#xD;
      accurate as possible - diagnosis without compromising the limited available resources. Such&#xD;
      protocol shall make full use of the three main traditional pillars: Clinical picture,&#xD;
      Ancillary Diagnostic Tests and Chest imaging before proceeding to the PCR testing:&#xD;
&#xD;
        1. Clinical Picture: Symptomatic COVID-19 presents with a recognizable clinical syndrome&#xD;
           that is predictable prior to testing. Clinical judgement remains important, particularly&#xD;
           when interpreting negative test results;&#xD;
&#xD;
        2. Biomarkers Associated with COVID-19 Patients: The most common laboratory features&#xD;
           reported in patients with COVID-19 include: • Decreased albumin; • Elevated C-reactive&#xD;
           protein ; • Elevated lactate dehydrogenase levels ; and • Lymphopenia .&#xD;
&#xD;
        3. Other biomarkers that have been reported include increased erythrocyte sedimentation&#xD;
           rates; elevated aspartate aminotransferase, alanine aminotransferase, and creatine&#xD;
           kinase levels, leukopenia, leukocytosis, increased bilirubin and creatinine levels. No&#xD;
           biomarker or combination of biomarkers currently exists that is sensitive or specific&#xD;
           enough to establish a diagnosis of COVID-19, or to pragmatically predict its clinical&#xD;
           course.&#xD;
&#xD;
        4. Radiographic Tests: Many centers have evaluated the utility of chest imaging for&#xD;
           diagnosis: • On chest radiography, bilateral pneumonia is the most frequently reported&#xD;
           feature (range,11.8% to 100%) and is more common than a unilateral focus; • Computed&#xD;
           tomography is regarded as more sensitive than radiography, with several cohort studies&#xD;
           reporting that most patients (77.8% to 100%) had ground glass opacities. Other features&#xD;
           commonly reported with COVID-19 on chest computed tomography include a peripheral&#xD;
           distribution, fine reticular opacities, and vascular thickening. Compared with serial&#xD;
           nasopharyngeal sampling, chest computed tomography may be more sensitive than an RT-PCR&#xD;
           test at a single time point for the diagnosis of COVID-19. In addition, artificial&#xD;
           intelligence may help distinguish COVID-19 from other etiologic agents of&#xD;
           community-acquired pneumonia. However, these findings are not completely specific to&#xD;
           COVID-19 and do not exclude a co-infection or an alternative diagnosis.&#xD;
&#xD;
      CPR: Who Should Be Tested? The current situation exemplifies the challenge of how to best&#xD;
      utilize testing during outbreaks of novel pathogens. The initial testing criteria were too&#xD;
      narrow to monitor and control the spread of the disease, but the sudden pivot to a far&#xD;
      broader testing approach, even as capacity remains limited, may be an overcorrection. As of&#xD;
      March 4, CDC discontinued specific guidance and recommends that &quot;clinicians should use their&#xD;
      judgment to determine if a patient has signs and symptoms compatible with COVID-19 and&#xD;
      whether the patient should be tested,&quot; advising that &quot;decisions on which patients receive&#xD;
      testing should be based on the local epidemiology of COVID-19, as well as the clinical course&#xD;
      of illness.&quot; High priorities for testing include patients with serious, unexplained&#xD;
      respiratory illness and contacts of known cases, Methods: It is a comparative study between&#xD;
      tests to diagnose COVID-19. In developed countries (in which Egypt is one of them) PCR is&#xD;
      high cost. Though much of cases escape Diagnosis and clinician depend on clinical picture&#xD;
      only. This study would allow to find what degree of dependence on other tests. In this study,&#xD;
      100 cases positive COVID-19 by PCR will be analyzed and tested for other ancillary tests and&#xD;
      CT chest to compare them and find out which is the most sensitive in both moderate and severe&#xD;
      clinical condition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 15, 2020</start_date>
  <completion_date type="Anticipated">September 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 15, 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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>correlation of COVID-19 antibody to PCR</measure>
    <time_frame>1 year</time_frame>
    <description>Finding the correlation between the results of COVID-19 RT PCR, antibody to PCR COVID-19 IgM &amp; IgG and the severity of the clinical picture</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>correlation of ancillaey tests to PCR</measure>
    <time_frame>1 year</time_frame>
    <description>Finding the correlation between the results of the ancillary tests (CRP, ESR, LFT, Ferritin, D dimer) and the severity of the clinical picture</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Positive COVID-19 by PCR</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Rt PCR</intervention_name>
    <description>positive COVID-19 by PCR and tested for other ancillary tests and CT chest to compare them and analyse which is the most sensitive in both moderate and severe clinical condition</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        positive COVID-19 by PCR and tested for other ancillary tests and CT chest to compare them&#xD;
        and analyse which is the most sensitive in both moderate and severe clinical condition&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All cases positive COVID 19 RT PCR&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cases with chronic diseases ( cancers, diabetes Liver or Kidney )&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Days</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Prof. Refat Sadeq</name>
      <address>
        <city>Port Said</city>
        <zip>22223</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Refat A. Sadeq, Ph D</last_name>
      <phone>01003737012</phone>
      <email>refat.sadek@med.psu.edu.eg</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID 19</keyword>
  <keyword>Rt PCR</keyword>
  <keyword>CT</keyword>
  <keyword>Rapid tests</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Disease Progression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04484597
org study id: Prof. Refat Sadeq
nct id: NCT04484597
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Clinical Picture: Symptomatic COVID-19 presents with a recognizable clinical syndrome that is
      predictable prior to testing. Clinical judgement remains important, particularly when
      interpreting negative test results; 2. Biomarkers Associated with COVID-19 Patients: The most
      common laboratory features reported in patients with COVID-19
The COVID-19 pandemic put tremendous pressures on the public health system and the health
      workers in almost every country around the world. Egypt was no exception, one of the main
      challenges faced is the limited number of CPR centers, equipment and kits which consequently
      affecting the number of tests that could be performed.

      Although testing is critical, clinical judgement is the first mean to evaluate patients for
      COVID-19. Ancillary Diagnostic Tests and Chest imaging are also important tools before
      proceeding to the PCR testing. However, important gaps remain in screening asymptomatic
      persons in the incubation phase, as well as in the accurate determination of live viral
      shedding during convalescence to inform decisions to end isolation. The main objectives of
      the study: To set an evidence-based protocol with some criteria and procedures to reach - as
      accurate as possible - diagnosis without compromising the limited available resources. Such
      protocol shall make full use of the three main traditional pillars: Clinical picture,
      Ancillary Diagnostic Tests and Chest imaging before proceeding to the PCR testing:

        1. Clinical Picture: Symptomatic COVID-19 presents with a recognizable clinical syndrome
           that is predictable prior to testing. Clinical judgement remains important, particularly
           when interpreting negative test results;

        2. Biomarkers Associated with COVID-19 Patients: The most common laboratory features
           reported in patients with COVID-19 include: • Decreased albumin; • Elevated C-reactive
           protein ; • Elevated lactate dehydrogenase levels ; and • Lymphopenia .

        3. Other biomarkers that have been reported include increased erythrocyte sedimentation
           rates; elevated aspartate aminotransferase, alanine aminotransferase, and creatine
           kinase levels, leukopenia, leukocytosis, increased bilirubin and creatinine levels. No
           biomarker or combination of biomarkers currently exists that is sensitive or specific
           enough to establish a diagnosis of COVID-19, or to pragmatically predict its clinical
           course.

        4. Radiographic Tests: Many centers have evaluated the utility of chest imaging for
           diagnosis: • On chest radiography, bilateral pneumonia is the most frequently reported
           feature (range,11.8% to 100%) and is more common than a unilateral focus; • Computed
           tomography is regarded as more sensitive than radiography, with several cohort studies
           reporting that most patients (77.8% to 100%) had ground glass opacities. Other features
           commonly reported with COVID-19 on chest computed tomography include a peripheral
           distribution, fine reticular opacities, and vascular thickening. Compared with serial
           nasopharyngeal sampling, chest computed tomography may be more sensitive than an RT-PCR
           test at a single time point for the diagnosis of COVID-19. In addition, artificial
           intelligence may help distinguish COVID-19 from other etiologic agents of
           community-acquired pneumonia. However, these findings are not completely specific to
           COVID-19 and do not exclude a co-infection or an alternative diagnosis.

      CPR: Who Should Be Tested? The current situation exemplifies the challenge of how to best
      utilize testing during outbreaks of novel pathogens. The initial testing criteria were too
      narrow to monitor and control the spread of the disease, but the sudden pivot to a far
      broader testing approach, even as capacity remains limited, may be an overcorrection. As of
      March 4, CDC discontinued specific guidance and recommends that "clinicians should use their
      judgment to determine if a patient has signs and symptoms compatible with COVID-19 and
      whether the patient should be tested," advising that "decisions on which patients receive
      testing should be based on the local epidemiology of COVID-19, as well as the clinical course
      of illness." High priorities for testing include patients with serious, unexplained
      respiratory illness and contacts of known cases, Methods: It is a comparative study between
      tests to diagnose COVID-19. In developed countries (in which Egypt is one of them) PCR is
      high cost. Though much of cases escape Diagnosis and clinician depend on clinical picture
      only. This study would allow to find what degree of dependence on other tests. In this study,
      100 cases positive COVID-19 by PCR will be analyzed and tested for other ancillary tests and
      CT chest to compare them and find out which is the most sensitive in both moderate and severe
      clinical condition.
observational model: Case-Control
time perspective: Cross-Sectional
measure: correlation of COVID-19 antibody to PCR
time frame: 1 year
description: Finding the correlation between the results of COVID-19 RT PCR, antibody to PCR COVID-19 IgM & IgG and the severity of the clinical picture
measure: correlation of ancillaey tests to PCR
time frame: 1 year
description: Finding the correlation between the results of the ancillary tests (CRP, ESR, LFT, Ferritin, D dimer) and the severity of the clinical picture
intervention type: Diagnostic Test
intervention name: Rt PCR
description: positive COVID-19 by PCR and tested for other ancillary tests and CT chest to compare them and analyse which is the most sensitive in both moderate and severe clinical condition
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 4 Days
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Disease Progression
sharing ipd: No