<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/NCT04445415</url>
  </required_header>
  <id_info>
    <org_study_id>COVID-19 antibodies testing</org_study_id>
    <nct_id>NCT04445415</nct_id>
  </id_info>
  <brief_title>Diagnostic Value of New COVID-19 Antibodies Testing Among Laboratory Healthcare Workers</brief_title>
  <official_title>Diagnostic Value of New- Covid 19 Antibodies Testing Among Laboratory Healthcare Workers</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>
      COVID-19 antibodies testing among healthcare workers to evaluate the role of Covid 19Ab&#xD;
      testing as screening method for detection of covid 19 infections among laboratory health care&#xD;
      workers ,assess the relationship between the infection with Covid 19 and different laboratory&#xD;
      categories/area and assessemt of efficiency personal protective equipment (PPE) in different&#xD;
      laboratory categories/area.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In December 2019, a new corona virus (CoV) emerged in China to cause an acute respiratory&#xD;
      disease known as corona virus disease 19 (COVID-19).The virus was identified to be a&#xD;
      betacoronavirus related to severe acute respiratory syndrome corona virus (SARS-CoV) and&#xD;
      thus, was named SARS-CoV-2 .&#xD;
&#xD;
      New Covid-19 virus is the third known corona virus to cross the species barrier and cause&#xD;
      severe respiratory infections in humans following SARS-CoV in 2003 and Middle East&#xD;
      respiratory syndrome in 2012, yet with pandemic spread compared to the earlier two. In&#xD;
      comparison, to SARS-CoV and MERS-CoV, COVID-19 virus exhibits faster human-to-human&#xD;
      transmission.&#xD;
&#xD;
      The World Health Organization (WHO) declared COVID-19 outbreak as a world pandemic on 12th&#xD;
      March 2020. Diagnosis of suspected cases is confirmed by molecular techniques (real-time&#xD;
      PCR), using respiratory samples. Serology tests are easier to perform than molecular testing,&#xD;
      but their utility may be limited by the performance and the fact that antibodies appear later&#xD;
      during the disease course.&#xD;
&#xD;
      In the absence of a vaccine, public health authorities in several countries has shown that&#xD;
      shutdowns can only be safely ended if a systematic &quot;test and trace&quot; program is put in place&#xD;
      to control the spread of the virus which depends on the widespread availability of mass&#xD;
      diagnostic testing.&#xD;
&#xD;
      From this point of view, detecting carriers of the virus in asymptomatic laboratory health&#xD;
      care worker is fundamental to response efforts. It ensures the quarantine of COVID-19&#xD;
      patients to prevent local spread and more broadly informs national response measures.&#xD;
&#xD;
      The main route of transmission is person-to-person spread. A vulnerable cohort for infection&#xD;
      due to frequent and close contact to COVID-19 patients are healthcare workers. To avoid&#xD;
      patient-to-staff transmission adherence to strict hygiene standards is important. The&#xD;
      infection with the SARS-CoV-2 usually leads to seroconversion 11-14 days after the first&#xD;
      symptoms . However, due to asymptomatic and oligosymptomatic infections testing only&#xD;
      symptomatic individuals can lead to a significant underestimation of the SARS-CoV-2&#xD;
      seroprevalence Day,.&#xD;
&#xD;
      Antibody testing is multipurpose: these serological assays are of critical importance to&#xD;
      determine seroprevalence, previous exposure and identify highly reactive human donors for the&#xD;
      generation of convalescent serum as therapeutic. They will support contact tracing and&#xD;
      screening of health care workers to identify those who are already immune. How many people&#xD;
      really got infected, in how many did the virus escape the PCR diagnosis, and for what&#xD;
      reasons, how many patients are asymptomatic, and what is the real mortality rate in a defined&#xD;
      population? Only with comprehensive serology testing (and well-planned epidemiological&#xD;
      studies) will we be able to answer these questions and reduce the ubiquitous undisclosed&#xD;
      number in the current calculations. Several investigations are already underway in a wide&#xD;
      variety of locations worldwide&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 1, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>diagnostic value of COVID-19 antibodies testing</measure>
    <time_frame>baseline</time_frame>
    <description>these serological assays are of critical importance to determine previous exposure,How many people really got infected, and for what reasons, how many patients are asymptomatic, and what is the real mortality rate in a defined population</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Role of COVID -19 Antibodies testing in treatment of Patients</measure>
    <time_frame>Baseline</time_frame>
    <description>these serological assays are of critical importance to determine seroprevalence, previous exposure and identify highly reactive human donors for the generation of convalescent serum as therapeutic method for infected persons</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assement of COVID -19 prevalence among healthcare workers</measure>
    <time_frame>Baseline</time_frame>
    <description>Serological assay of COVID-19 antibodies testing will support contact tracing and screening of health care workers to identify those who are already immune. How many people really got infected, in how many did the virus escape the PCR diagnosis, and for what reasons, how many patients are asymptomatic, and what is the real mortality rate in a defined population</description>
  </primary_outcome>
  <enrollment type="Anticipated">250</enrollment>
  <condition>COVID-19</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>COVID-19 antibodies testing</intervention_name>
    <description>antibodies aganist COVID-19 detected in the serum of patients</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        the study was carried out using EPI info 2000 statistical package and based on a CDC&#xD;
        COVID-19 Response Team report where the prevalence of COVID 19 infected health care workers&#xD;
        (CDC, 2020) The minimum calculated sample was 250 health care worker , with confidence&#xD;
        interval 80%.&#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>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Samar Salah Eldin</last_name>
    <phone>+201117296242</phone>
    <email>samarsalah166@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Azza Ezzeldin, Professor</last_name>
    <phone>+201001918207</phone>
    <email>Azzam80@hotmail.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Zainol Rashid Z, Othman SN, Abdul Samat MN, Ali UK, Wong KK. Diagnostic performance of COVID-19 serology assays. Malays J Pathol. 2020 Apr;42(1):13-21.</citation>
    <PMID>32342927</PMID>
  </reference>
  <reference>
    <citation>Salathe M, Althaus CL, Neher R, Stringhini S, Hodcroft E, Fellay J, Zwahlen M, Senti G, Battegay M, Wilder-Smith A, Eckerle I, Egger M, Low N. COVID-19 epidemic in Switzerland: on the importance of testing, contact tracing and isolation. Swiss Med Wkly. 2020 Mar 19;150:w20225. doi: 10.4414/smw.2020.20225. eCollection 2020 Mar 9.</citation>
    <PMID>32191813</PMID>
  </reference>
  <reference>
    <citation>Day M. Covid-19: identifying and isolating asymptomatic people helped eliminate virus in Italian village. BMJ. 2020 Mar 23;368:m1165. doi: 10.1136/bmj.m1165. No abstract available.</citation>
    <PMID>32205334</PMID>
  </reference>
  <reference>
    <citation>Long QX, Liu BZ, Deng HJ, Wu GC, Deng K, Chen YK, Liao P, Qiu JF, Lin Y, Cai XF, Wang DQ, Hu Y, Ren JH, Tang N, Xu YY, Yu LH, Mo Z, Gong F, Zhang XL, Tian WG, Hu L, Zhang XX, Xiang JL, Du HX, Liu HW, Lang CH, Luo XH, Wu SB, Cui XP, Zhou Z, Zhu MM, Wang J, Xue CJ, Li XF, Wang L, Li ZJ, Wang K, Niu CC, Yang QJ, Tang XJ, Zhang Y, Liu XM, Li JJ, Zhang DC, Zhang F, Liu P, Yuan J, Li Q, Hu JL, Chen J, Huang AL. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med. 2020 Jun;26(6):845-848. doi: 10.1038/s41591-020-0897-1. Epub 2020 Apr 29.</citation>
    <PMID>32350462</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Samar Salah Eldin Abdelrahman Sultan</investigator_full_name>
    <investigator_title>Resident physician</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies</mesh_term>
  </intervention_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/NCT04445415
org study id: COVID-19 antibodies testing
nct id: NCT04445415
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
COVID-19 antibodies testing among healthcare workers to evaluate the role of Covid 19Ab
      testing as screening method for detection of covid 19 infections among laboratory health care
      workers ,assess the relationship between the infection with Covid 19 and different laboratory
      categories/area and assessemt of efficiency personal protective equipment (PPE) in different
      laboratory categories/area.
In December 2019, a new corona virus (CoV) emerged in China to cause an acute respiratory
      disease known as corona virus disease 19 (COVID-19).The virus was identified to be a
      betacoronavirus related to severe acute respiratory syndrome corona virus (SARS-CoV) and
      thus, was named SARS-CoV-2 .

      New Covid-19 virus is the third known corona virus to cross the species barrier and cause
      severe respiratory infections in humans following SARS-CoV in 2003 and Middle East
      respiratory syndrome in 2012, yet with pandemic spread compared to the earlier two. In
      comparison, to SARS-CoV and MERS-CoV, COVID-19 virus exhibits faster human-to-human
      transmission.

      The World Health Organization (WHO) declared COVID-19 outbreak as a world pandemic on 12th
      March 2020. Diagnosis of suspected cases is confirmed by molecular techniques (real-time
      PCR), using respiratory samples. Serology tests are easier to perform than molecular testing,
      but their utility may be limited by the performance and the fact that antibodies appear later
      during the disease course.

      In the absence of a vaccine, public health authorities in several countries has shown that
      shutdowns can only be safely ended if a systematic "test and trace" program is put in place
      to control the spread of the virus which depends on the widespread availability of mass
      diagnostic testing.

      From this point of view, detecting carriers of the virus in asymptomatic laboratory health
      care worker is fundamental to response efforts. It ensures the quarantine of COVID-19
      patients to prevent local spread and more broadly informs national response measures.

      The main route of transmission is person-to-person spread. A vulnerable cohort for infection
      due to frequent and close contact to COVID-19 patients are healthcare workers. To avoid
      patient-to-staff transmission adherence to strict hygiene standards is important. The
      infection with the SARS-CoV-2 usually leads to seroconversion 11-14 days after the first
      symptoms . However, due to asymptomatic and oligosymptomatic infections testing only
      symptomatic individuals can lead to a significant underestimation of the SARS-CoV-2
      seroprevalence Day,.

      Antibody testing is multipurpose: these serological assays are of critical importance to
      determine seroprevalence, previous exposure and identify highly reactive human donors for the
      generation of convalescent serum as therapeutic. They will support contact tracing and
      screening of health care workers to identify those who are already immune. How many people
      really got infected, in how many did the virus escape the PCR diagnosis, and for what
      reasons, how many patients are asymptomatic, and what is the real mortality rate in a defined
      population? Only with comprehensive serology testing (and well-planned epidemiological
      studies) will we be able to answer these questions and reduce the ubiquitous undisclosed
      number in the current calculations. Several investigations are already underway in a wide
      variety of locations worldwide
observational model: Case-Only
time perspective: Retrospective
measure: diagnostic value of COVID-19 antibodies testing
time frame: baseline
description: these serological assays are of critical importance to determine previous exposure,How many people really got infected, and for what reasons, how many patients are asymptomatic, and what is the real mortality rate in a defined population
measure: Role of COVID -19 Antibodies testing in treatment of Patients
time frame: Baseline
description: these serological assays are of critical importance to determine seroprevalence, previous exposure and identify highly reactive human donors for the generation of convalescent serum as therapeutic method for infected persons
measure: Assement of COVID -19 prevalence among healthcare workers
time frame: Baseline
description: Serological assay of COVID-19 antibodies testing will support contact tracing and screening of health care workers to identify those who are already immune. How many people really got infected, in how many did the virus escape the PCR diagnosis, and for what reasons, how many patients are asymptomatic, and what is the real mortality rate in a defined population
intervention type: Diagnostic Test
intervention name: COVID-19 antibodies testing
description: antibodies aganist COVID-19 detected in the serum of patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Samar Salah Eldin
phone: +201117296242
email: samarsalah166@hotmail.com
last name: Azza Ezzeldin, Professor
phone: +201001918207
email: Azzam80@hotmail.com
citation: Zainol Rashid Z, Othman SN, Abdul Samat MN, Ali UK, Wong KK. Diagnostic performance of COVID-19 serology assays. Malays J Pathol. 2020 Apr;42(1):13-21.
PMID: 32342927
citation: Salathe M, Althaus CL, Neher R, Stringhini S, Hodcroft E, Fellay J, Zwahlen M, Senti G, Battegay M, Wilder-Smith A, Eckerle I, Egger M, Low N. COVID-19 epidemic in Switzerland: on the importance of testing, contact tracing and isolation. Swiss Med Wkly. 2020 Mar 19;150:w20225. doi: 10.4414/smw.2020.20225. eCollection 2020 Mar 9.
PMID: 32191813
citation: Day M. Covid-19: identifying and isolating asymptomatic people helped eliminate virus in Italian village. BMJ. 2020 Mar 23;368:m1165. doi: 10.1136/bmj.m1165. No abstract available.
PMID: 32205334
citation: Long QX, Liu BZ, Deng HJ, Wu GC, Deng K, Chen YK, Liao P, Qiu JF, Lin Y, Cai XF, Wang DQ, Hu Y, Ren JH, Tang N, Xu YY, Yu LH, Mo Z, Gong F, Zhang XL, Tian WG, Hu L, Zhang XX, Xiang JL, Du HX, Liu HW, Lang CH, Luo XH, Wu SB, Cui XP, Zhou Z, Zhu MM, Wang J, Xue CJ, Li XF, Wang L, Li ZJ, Wang K, Niu CC, Yang QJ, Tang XJ, Zhang Y, Liu XM, Li JJ, Zhang DC, Zhang F, Liu P, Yuan J, Li Q, Hu JL, Chen J, Huang AL. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med. 2020 Jun;26(6):845-848. doi: 10.1038/s41591-020-0897-1. Epub 2020 Apr 29.
PMID: 32350462
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Samar Salah Eldin Abdelrahman Sultan
investigator title: Resident physician
mesh term: COVID-19
mesh term: Antibodies