<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/NCT04409574</url>
  </required_header>
  <id_info>
    <org_study_id>COVID19 among HCWs</org_study_id>
    <nct_id>NCT04409574</nct_id>
  </id_info>
  <brief_title>COVID 19 Viral Clearance Among the Infected Healthcare Workers In Assiut University Hospitals</brief_title>
  <official_title>COVID19 Viral Clearance Among the Infected Healthcare Workers In Assiut University Hospitals</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>
      This work was aimed to determine the time of COVID 19 viral clearance in healthcare workers,&#xD;
      assessment of clinical presentation and severity of COVID 19 infection among healthcare&#xD;
      workers and discover relation between the time of COVID 19 viral clearance resolution of&#xD;
      symptoms&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COVID-19 has been spreading rapidly globally, with a considerable impact on global morbidity,&#xD;
      mortality and healthcare utilization. This viral disease is caused by the Coronaviruses (CoV)&#xD;
      which belong to the genus'coronavirus' of the Coronaviridae family.&#xD;
&#xD;
      Coronaviruses are enveloped positive strand RNA viruses with the largest known RNA&#xD;
      genomes-30-32 kb-with a 50 -cap structure and 30 -poly-A tail (Lei et al.2018). The&#xD;
      transcription works through the replication-transcription complex (RCT) organized in&#xD;
      double-membrane vesicles and via the synthesis of subgenomic RNAs (sgRNAs) sequences. Of&#xD;
      note, transcription termination occurs at transcription regulatory sequences, located between&#xD;
      the so-called open reading frames (ORFs). In the atypical CoV genome, at least six ORF scan&#xD;
      could be present (Woo et al., 2020) .&#xD;
&#xD;
      Health workers are at the front line of the COVID-19 outbreak response and as such are&#xD;
      exposed to hazards that put them at risk of infection (Li e al.,2020). thus keeping the&#xD;
      implementation of infection prevention and control (IPC) and its knowledge and practice are&#xD;
      of great importance in healthcare settings to protect them from infections (Wang et al.,&#xD;
      2020).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 2020</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">March 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>the time of Covid 19 viral clearance in medical healthcare workers and its relation to clinical presentation, severity among and resolution of symptoms.</measure>
    <time_frame>basline</time_frame>
    <description>different relations between different symptoms, investigation results and time of viral clearness</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>knowledge and practice of infection control measures</measure>
    <time_frame>baseline</time_frame>
    <description>good and bad knowledge or practice</description>
  </secondary_outcome>
  <enrollment type="Anticipated">31</enrollment>
  <condition>Infection, Coronavirus</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      -  Complete Blood Count (CBC) by (Pentra 80 Horiba blood counter).&#xD;
&#xD;
        -  Erythrocyte Sedimentation Rate (ESR) by westergren method.&#xD;
&#xD;
        -  Liver function , Kidney function tests, triglyceride , LDH, CK, CK-MB Na, K, Mg,&#xD;
           Phosphorus, Ca, CRP, Ferritin ) (Dimension RXLautomated blood chemistry analyser).&#xD;
&#xD;
        -  HCV Ab, HBsAg and HIV Ag-Ab on Abott Architect i1000R&#xD;
&#xD;
        -  Prothrombin time , concentration, INR and D-Dimerand on sysmex 1500 corona virus&#xD;
           investigation: Viral RNA extraction by Qiagen viral RNA extraction large volume: on&#xD;
           QiAcube extractor&#xD;
&#xD;
             -  Coronavirus (Covid -19) genesig Real time PCR assay : on 7500 fast Applied&#xD;
                biosystem&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Covid 19 infected healthcare workers in Assiut University Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Covid 19 infected healthcare workers.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Risky healthcare workers (diabetic hypertensive and more than 50 years)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mariam elkhayat, lecturer</last_name>
    <phone>00201003708261</phone>
    <phone_ext>00201003708261</phone_ext>
    <email>mariam.elkhayat@aun.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Azza Ezzeldin, professor</last_name>
    <phone>01001918207</phone>
    <email>Azzam80@hotmail.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.</citation>
    <PMID>31995857</PMID>
  </reference>
  <reference>
    <citation>Lei J, Kusov Y, Hilgenfeld R. Nsp3 of coronaviruses: Structures and functions of a large multi-domain protein. Antiviral Res. 2018 Jan;149:58-74. doi: 10.1016/j.antiviral.2017.11.001. Epub 2017 Nov 8.</citation>
    <PMID>29128390</PMID>
  </reference>
  <reference>
    <citation>Wang J, Zhou M, Liu F. Reasons for healthcare workers becoming infected with novel coronavirus disease 2019 (COVID-19) in China. J Hosp Infect. 2020 May;105(1):100-101. doi: 10.1016/j.jhin.2020.03.002. Epub 2020 Mar 6. No abstract available.</citation>
    <PMID>32147406</PMID>
  </reference>
  <reference>
    <citation>Woo PCY, Huang Y, Lau SKP, Yuen KY. Coronavirus genomics and bioinformatics analysis. Viruses. 2010 Aug;2(8):1804-1820. doi: 10.3390/v2081803. Epub 2010 Aug 24.</citation>
    <PMID>21994708</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mariam Roshdy Elkhayat</investigator_full_name>
    <investigator_title>lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronavirus Infections</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/NCT04409574
org study id: COVID19 among HCWs
nct id: NCT04409574
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This work was aimed to determine the time of COVID 19 viral clearance in healthcare workers,
      assessment of clinical presentation and severity of COVID 19 infection among healthcare
      workers and discover relation between the time of COVID 19 viral clearance resolution of
      symptoms
COVID-19 has been spreading rapidly globally, with a considerable impact on global morbidity,
      mortality and healthcare utilization. This viral disease is caused by the Coronaviruses (CoV)
      which belong to the genus'coronavirus' of the Coronaviridae family.

      Coronaviruses are enveloped positive strand RNA viruses with the largest known RNA
      genomes-30-32 kb-with a 50 -cap structure and 30 -poly-A tail (Lei et al.2018). The
      transcription works through the replication-transcription complex (RCT) organized in
      double-membrane vesicles and via the synthesis of subgenomic RNAs (sgRNAs) sequences. Of
      note, transcription termination occurs at transcription regulatory sequences, located between
      the so-called open reading frames (ORFs). In the atypical CoV genome, at least six ORF scan
      could be present (Woo et al., 2020) .

      Health workers are at the front line of the COVID-19 outbreak response and as such are
      exposed to hazards that put them at risk of infection (Li e al.,2020). thus keeping the
      implementation of infection prevention and control (IPC) and its knowledge and practice are
      of great importance in healthcare settings to protect them from infections (Wang et al.,
      2020).
observational model: Case-Only
time perspective: Cross-Sectional
measure: the time of Covid 19 viral clearance in medical healthcare workers and its relation to clinical presentation, severity among and resolution of symptoms.
time frame: basline
description: different relations between different symptoms, investigation results and time of viral clearness
measure: knowledge and practice of infection control measures
time frame: baseline
description: good and bad knowledge or practice
-  Complete Blood Count (CBC) by (Pentra 80 Horiba blood counter).

        -  Erythrocyte Sedimentation Rate (ESR) by westergren method.

        -  Liver function , Kidney function tests, triglyceride , LDH, CK, CK-MB Na, K, Mg,
           Phosphorus, Ca, CRP, Ferritin ) (Dimension RXLautomated blood chemistry analyser).

        -  HCV Ab, HBsAg and HIV Ag-Ab on Abott Architect i1000R

        -  Prothrombin time , concentration, INR and D-Dimerand on sysmex 1500 corona virus
           investigation: Viral RNA extraction by Qiagen viral RNA extraction large volume: on
           QiAcube extractor

             -  Coronavirus (Covid -19) genesig Real time PCR assay : on 7500 fast Applied
                biosystem
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Mariam elkhayat, lecturer
phone: 00201003708261
phone ext: 00201003708261
email: mariam.elkhayat@aun.edu.eg
last name: Azza Ezzeldin, professor
phone: 01001918207
email: Azzam80@hotmail.com
citation: Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.
PMID: 31995857
citation: Lei J, Kusov Y, Hilgenfeld R. Nsp3 of coronaviruses: Structures and functions of a large multi-domain protein. Antiviral Res. 2018 Jan;149:58-74. doi: 10.1016/j.antiviral.2017.11.001. Epub 2017 Nov 8.
PMID: 29128390
citation: Wang J, Zhou M, Liu F. Reasons for healthcare workers becoming infected with novel coronavirus disease 2019 (COVID-19) in China. J Hosp Infect. 2020 May;105(1):100-101. doi: 10.1016/j.jhin.2020.03.002. Epub 2020 Mar 6. No abstract available.
PMID: 32147406
citation: Woo PCY, Huang Y, Lau SKP, Yuen KY. Coronavirus genomics and bioinformatics analysis. Viruses. 2010 Aug;2(8):1804-1820. doi: 10.3390/v2081803. Epub 2010 Aug 24.
PMID: 21994708
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mariam Roshdy Elkhayat
investigator title: lecturer
mesh term: Coronavirus Infections