<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/NCT04470557</url>
  </required_header>
  <id_info>
    <org_study_id>RLCS</org_study_id>
    <nct_id>NCT04470557</nct_id>
  </id_info>
  <brief_title>Relation Between Lab Finding and COVID-19 Severity</brief_title>
  <official_title>The Relationship Between Lab Finding and COVID-19 Severity: Multicenter Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      Severe acute respiratory syndrome coronavirus 2 (COVID-19) poses substantial challenges for&#xD;
      health care systems. With a vastly expanding amount of publications on COVID-19, clinicians&#xD;
      need evidence synthesis to produce guidance for handling patients with COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      . Conavirus belongs to the subfamily of Ortho-coronavirinae in the family of Coronaviridae&#xD;
      and the Order Nidovirales. In 2003, a SARS-CoV had caused the out- break of severe acute&#xD;
      respiratory syndrome. In December 2019, an &quot;unknown viral pneumonia&quot; out- break has been&#xD;
      reported. Finally, a novel coronavirus was detected, isolated virus was termed as SARS-CoV2,&#xD;
      characterized as highly contagious and deadly. By the end of February 2020, more than 78,631&#xD;
      cases infected with SARS-CoV-2, and more than 2747 deaths were confrmed in China, and the&#xD;
      COVID-19 has been declared a pan- demic by World Health Organization. For those infected by&#xD;
      SARS-CoV-2, some of the patients didnot show hypoxemia or respiratory stress during the&#xD;
      course of COVID-19, indicating a multifaceted disease of SARS-CoV-2 infection. Therefore, one&#xD;
      reliable and convenient biomarker is needed to predict the severity of COVID-19 pneumonia.&#xD;
      Recently, several studies have reported that C-reactive protein (CRP) is positively&#xD;
      asso-ciated with severe dengue infection, and patients with higher plasma CRP in the initial&#xD;
      period of dengue, are at higher risk to develop plasma leakage. We examined which routine&#xD;
      laboratory tests are associated with severe COVID-19 disease, and the relation between the&#xD;
      laboratory results and the security of COVID19 diasease, in two of large Upper Egypt medical&#xD;
      centers, which are Aswan University and assiut university hospitals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 15, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Estimation of severity of patients with COVID-19 in relation to Laboratory findings.</measure>
    <time_frame>up to 1 month</time_frame>
    <description>with successful completion of the aim, the investigators will establish the correlation between laboratory findings and severity of COVID-19 patients according to WHO classification.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Patients with COVID-19</arm_group_label>
    <description>The patients will be subjected to to laboratory analyses, a number of hematological, immunological and biochemical parameters like total leucocytic count and differential count of CBC, ESR, D- dimer levels in plasma, CRP, serum urea and creatinine levels, serum levels of AST, ALT liver enzymes, serum ferritin levels Also, CT scan of chest, clinical assessment and the severity and course of the disease.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>D-dimer,CBC.ESR,CRP,</intervention_name>
    <description>Complete blood count (for patients and control subjects): was done on CELL-DYN 3700 (Abbott-Germany) and blood film was stained by leishman staining, the morphology of red blood cells. CRP titre estimation by latix method .ESR erythrocyte sedimentation rate estimation (1:5) by Westerngreen tube method.</description>
    <arm_group_label>Patients with COVID-19</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Liver function tests ,serum ferritin and PCR for COVID-19 .</intervention_name>
    <description>Serum ferritin was performed for all subjects on Modular P auto analyzer (Roche Diagnostics, Mannheim, Germany),&#xD;
• Liver function tests ( aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase) and kidney funcrion were performed for all subjects on Modular P auto analyzer (Roche Diagnostics, Mannheim, G ermany),</description>
    <arm_group_label>Patients with COVID-19</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will be conducted on 100 patients with COVID-19 patients of all age groups and&#xD;
        both sexes.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: all ages.&#xD;
&#xD;
          -  Sex: Males and females.&#xD;
&#xD;
          -  COVID-19 patients approved by positive PCR.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with known chronic chest disease preceding the infection.&#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_official>
    <last_name>Esam_eldeen M. Abdalla, Doctorate</last_name>
    <role>Study Chair</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Heba Abdellatif, Doctorate</last_name>
    <role>Study Chair</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anwar M. Ali, Doctorate</last_name>
    <phone>01030361010</phone>
    <email>anwarmoha2006@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ghydaa A. Shehata, Doctorate</last_name>
  </overall_contact_backup>
  <reference>
    <citation>Zhang W, Du RH, Li B, Zheng XS, Yang XL, Hu B, Wang YY, Xiao GF, Yan B, Shi ZL, Zhou P. Molecular and serological investigation of 2019-nCoV infected patients: implication of multiple shedding routes. Emerg Microbes Infect. 2020 Feb 17;9(1):386-389. doi: 10.1080/22221751.2020.1729071. eCollection 2020.</citation>
    <PMID>32065057</PMID>
  </reference>
  <reference>
    <citation>Chen CC, Lee IK, Liu JW, Huang SY, Wang L. Utility of C-Reactive Protein Levels for Early Prediction of Dengue Severity in Adults. Biomed Res Int. 2015;2015:936062. doi: 10.1155/2015/936062. Epub 2015 Jul 12.</citation>
    <PMID>26247033</PMID>
  </reference>
  <results_reference>
    <citation>Alnor A, Sandberg MB, Gils C, Vinholt PJ. Laboratory Tests and Outcome for Patients with Coronavirus Disease 2019: A Systematic Review and Meta-Analysis. J Appl Lab Med. 2020 Sep 1;5(5):1038-1049. doi: 10.1093/jalm/jfaa098.</citation>
    <PMID>32573713</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 11, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Anwar Mohamed Ali</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>Laboratory</keyword>
  <keyword>Severity</keyword>
  <keyword>COVID-19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibrin fragment D</mesh_term>
  </intervention_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/NCT04470557
org study id: RLCS
nct id: NCT04470557
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Severe acute respiratory syndrome coronavirus 2 (COVID-19) poses substantial challenges for
      health care systems. With a vastly expanding amount of publications on COVID-19, clinicians
      need evidence synthesis to produce guidance for handling patients with COVID-19.
. Conavirus belongs to the subfamily of Ortho-coronavirinae in the family of Coronaviridae
      and the Order Nidovirales. In 2003, a SARS-CoV had caused the out- break of severe acute
      respiratory syndrome. In December 2019, an "unknown viral pneumonia" out- break has been
      reported. Finally, a novel coronavirus was detected, isolated virus was termed as SARS-CoV2,
      characterized as highly contagious and deadly. By the end of February 2020, more than 78,631
      cases infected with SARS-CoV-2, and more than 2747 deaths were confrmed in China, and the
      COVID-19 has been declared a pan- demic by World Health Organization. For those infected by
      SARS-CoV-2, some of the patients didnot show hypoxemia or respiratory stress during the
      course of COVID-19, indicating a multifaceted disease of SARS-CoV-2 infection. Therefore, one
      reliable and convenient biomarker is needed to predict the severity of COVID-19 pneumonia.
      Recently, several studies have reported that C-reactive protein (CRP) is positively
      asso-ciated with severe dengue infection, and patients with higher plasma CRP in the initial
      period of dengue, are at higher risk to develop plasma leakage. We examined which routine
      laboratory tests are associated with severe COVID-19 disease, and the relation between the
      laboratory results and the security of COVID19 diasease, in two of large Upper Egypt medical
      centers, which are Aswan University and assiut university hospitals.
observational model: Other
time perspective: Cross-Sectional
measure: Estimation of severity of patients with COVID-19 in relation to Laboratory findings.
time frame: up to 1 month
description: with successful completion of the aim, the investigators will establish the correlation between laboratory findings and severity of COVID-19 patients according to WHO classification.
arm group label: Patients with COVID-19
description: The patients will be subjected to to laboratory analyses, a number of hematological, immunological and biochemical parameters like total leucocytic count and differential count of CBC, ESR, D- dimer levels in plasma, CRP, serum urea and creatinine levels, serum levels of AST, ALT liver enzymes, serum ferritin levels Also, CT scan of chest, clinical assessment and the severity and course of the disease.
intervention type: Diagnostic Test
intervention name: D-dimer,CBC.ESR,CRP,
description: Complete blood count (for patients and control subjects): was done on CELL-DYN 3700 (Abbott-Germany) and blood film was stained by leishman staining, the morphology of red blood cells. CRP titre estimation by latix method .ESR erythrocyte sedimentation rate estimation (1:5) by Westerngreen tube method.
arm group label: Patients with COVID-19
intervention type: Diagnostic Test
intervention name: Liver function tests ,serum ferritin and PCR for COVID-19 .
description: Serum ferritin was performed for all subjects on Modular P auto analyzer (Roche Diagnostics, Mannheim, Germany),
• Liver function tests ( aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase) and kidney funcrion were performed for all subjects on Modular P auto analyzer (Roche Diagnostics, Mannheim, G ermany),
arm group label: Patients with COVID-19
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Esam_eldeen M. Abdalla, Doctorate
role: Study Chair
affiliation: Assiut University
last name: Heba Abdellatif, Doctorate
role: Study Chair
affiliation: Assiut University
last name: Anwar M. Ali, Doctorate
phone: 01030361010
email: anwarmoha2006@yahoo.com
last name: Ghydaa A. Shehata, Doctorate
citation: Zhang W, Du RH, Li B, Zheng XS, Yang XL, Hu B, Wang YY, Xiao GF, Yan B, Shi ZL, Zhou P. Molecular and serological investigation of 2019-nCoV infected patients: implication of multiple shedding routes. Emerg Microbes Infect. 2020 Feb 17;9(1):386-389. doi: 10.1080/22221751.2020.1729071. eCollection 2020.
PMID: 32065057
citation: Chen CC, Lee IK, Liu JW, Huang SY, Wang L. Utility of C-Reactive Protein Levels for Early Prediction of Dengue Severity in Adults. Biomed Res Int. 2015;2015:936062. doi: 10.1155/2015/936062. Epub 2015 Jul 12.
PMID: 26247033
citation: Alnor A, Sandberg MB, Gils C, Vinholt PJ. Laboratory Tests and Outcome for Patients with Coronavirus Disease 2019: A Systematic Review and Meta-Analysis. J Appl Lab Med. 2020 Sep 1;5(5):1038-1049. doi: 10.1093/jalm/jfaa098.
PMID: 32573713
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Anwar Mohamed Ali
investigator title: principal investigator
mesh term: COVID-19
mesh term: Fibrin fragment D
sharing ipd: No