<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/NCT04470414</url>
  </required_header>
  <id_info>
    <org_study_id>Cov-PH2020</org_study_id>
    <nct_id>NCT04470414</nct_id>
  </id_info>
  <brief_title>COVID-19 IgG Antibodies in the Serum of Recovered Patients</brief_title>
  <official_title>COVID-19 IgG Antibodies in the Serum of Recovered Patients: a Longitudinal 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>
      Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute&#xD;
      respiratory syndrome coronavirus 2 (SARS-CoV-2), which first appeared in China, in December&#xD;
      2019 and is now spreading worldwide and poses a great threat to public health. In 12th July&#xD;
      2020, the total number of cases worldwide was about 13 million cases with case fatality rate&#xD;
      of 4.4% and in Egypt the total cases was 81158 and case fatality rate was 4.6%. (1,2).&#xD;
&#xD;
      In recent years, novel coronaviruses emerge periodically in different areas around the world.&#xD;
      Severe acute respiratory syndrome coronavirus (SARS-CoV) occurred in 2002, which reportedly&#xD;
      infected 8422 people with about 10% case fatality rate (3). Middle East respiratory syndrome&#xD;
      coronavirus (MERS-CoV) was first identified in 2012 in Saudi Arabia, bringing a total of 1401&#xD;
      MERS-CoV infections, and about 35% case fatality rate (1). All the infection cases and recent&#xD;
      epidemics show that coronaviruses impose a continuous threat to human beings and the economy&#xD;
      as they emerge unexpectedly, spread easily, and lead to catastrophic consequences.&#xD;
&#xD;
      As the number of recovered patients with COVID-19 continues to be increasing, the strength&#xD;
      and duration of immunity after infection is an important point to be studied. Moreover,&#xD;
      understanding this issue is a critical point for controlling this epidemic as they are the&#xD;
      key for herd immunity and for informing decisions on how and when to ease physical distancing&#xD;
      restrictions and to be ready for other waves of the infection. There is currently no evidence&#xD;
      if the people who have recovered from COVID-19 have antibodies and protected from a second&#xD;
      attack of infection or future wave of this pandemic or not. Therefore, we will carry out a&#xD;
      longitudinal study of immunity in recovered patients to assess SARS-Cov2 patients' risk for&#xD;
      future reinfection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 1, 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>Levels of IgG in the serum of recovered COVID-19 patients</measure>
    <time_frame>3rd, 6th and 12th months post infection</time_frame>
    <description>Levels of IgG in the serum of recovered COVID-19 patients at different points during the first year of infection.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Factors related to IgG level</measure>
    <time_frame>1 year</time_frame>
    <description>The relationship between the IgG levels and severity of the disease, age of recovered patients and duration of symptoms and viral clearance.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>Recovered COVID-19 patients</arm_group_label>
    <description>Patients recovered from COVID-19 infection within three months before the start of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>IgG antibodies immunoassay</intervention_name>
    <description>Assessment of IgG level will be done by quantitative assessment of IgG in the serum of recovered persons by Chemiluminescence Immunoassay (CLIA).</description>
    <arm_group_label>Recovered COVID-19 patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients recovered from COVID-19 infection within three months before the start of the&#xD;
        study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged ≥ 20 years.&#xD;
&#xD;
          -  Prior COVID-19 infection confirmed by PCR detection of SARS-CoV-2 RNA or antigen in&#xD;
             nasopharyngeal swab.&#xD;
&#xD;
          -  Recovery from infection either confirmed by two consecutive negative PCR (collected&#xD;
             ≥24 hours apart) or passing of 14 days since onset of COVID-19 symptoms and at least 3&#xD;
             days since resolution of fever without the use of antipyretics and improvement of&#xD;
             respiratory symptoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of any chronic illness interfere with immunity (autoimmune diseases).&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Recovery from three months or more.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mahmoud A. Abd El Aty, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University- Faculty of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mariam T. Amin</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University- Faculty of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mariam T. Amin</last_name>
    <phone>00201064554080</phone>
    <email>mariam.amin015@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculty of medicine- Assiut university</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Mariam Amin</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <link>
    <url>https://www.who.int/emergencies/diseases/novel-coronavirus-2019/events-as-they-happen</url>
    <description>Coronavirus: Events as they happen</description>
  </link>
  <link>
    <url>https://www.worldometers.info/coronavirus/</url>
    <description>Coronavirus Update (Live): Cases and Deaths from COVID-19 Virus Pandemic</description>
  </link>
  <reference>
    <citation>Li G, Fan Y, Lai Y, Han T, Li Z, Zhou P, Pan P, Wang W, Hu D, Liu X, Zhang Q, Wu J. Coronavirus infections and immune responses. J Med Virol. 2020 Apr;92(4):424-432. doi: 10.1002/jmv.25685. Epub 2020 Feb 7.</citation>
    <PMID>31981224</PMID>
  </reference>
  <reference>
    <citation>Singhal T. A Review of Coronavirus Disease-2019 (COVID-19). Indian J Pediatr. 2020 Apr;87(4):281-286. doi: 10.1007/s12098-020-03263-6. Epub 2020 Mar 13.</citation>
    <PMID>32166607</PMID>
  </reference>
  <reference>
    <citation>Long QX, Tang XJ, Shi QL, Li Q, Deng HJ, Yuan J, Hu JL, Xu W, Zhang Y, Lv FJ, Su K, Zhang F, Gong J, Wu B, Liu XM, Li JJ, Qiu JF, Chen J, Huang AL. Clinical and immunological assessment of asymptomatic SARS-CoV-2 infections. Nat Med. 2020 Aug;26(8):1200-1204. doi: 10.1038/s41591-020-0965-6. Epub 2020 Jun 18.</citation>
    <PMID>32555424</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mariam T. Amin</investigator_full_name>
    <investigator_title>Assistant Lecturer</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>
    <mesh_term>Immunoglobulin G</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/NCT04470414
org study id: Cov-PH2020
nct id: NCT04470414
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute
      respiratory syndrome coronavirus 2 (SARS-CoV-2), which first appeared in China, in December
      2019 and is now spreading worldwide and poses a great threat to public health. In 12th July
      2020, the total number of cases worldwide was about 13 million cases with case fatality rate
      of 4.4% and in Egypt the total cases was 81158 and case fatality rate was 4.6%. (1,2).

      In recent years, novel coronaviruses emerge periodically in different areas around the world.
      Severe acute respiratory syndrome coronavirus (SARS-CoV) occurred in 2002, which reportedly
      infected 8422 people with about 10% case fatality rate (3). Middle East respiratory syndrome
      coronavirus (MERS-CoV) was first identified in 2012 in Saudi Arabia, bringing a total of 1401
      MERS-CoV infections, and about 35% case fatality rate (1). All the infection cases and recent
      epidemics show that coronaviruses impose a continuous threat to human beings and the economy
      as they emerge unexpectedly, spread easily, and lead to catastrophic consequences.

      As the number of recovered patients with COVID-19 continues to be increasing, the strength
      and duration of immunity after infection is an important point to be studied. Moreover,
      understanding this issue is a critical point for controlling this epidemic as they are the
      key for herd immunity and for informing decisions on how and when to ease physical distancing
      restrictions and to be ready for other waves of the infection. There is currently no evidence
      if the people who have recovered from COVID-19 have antibodies and protected from a second
      attack of infection or future wave of this pandemic or not. Therefore, we will carry out a
      longitudinal study of immunity in recovered patients to assess SARS-Cov2 patients' risk for
      future reinfection.
observational model: Cohort
time perspective: Prospective
measure: Levels of IgG in the serum of recovered COVID-19 patients
time frame: 3rd, 6th and 12th months post infection
description: Levels of IgG in the serum of recovered COVID-19 patients at different points during the first year of infection.
measure: Factors related to IgG level
time frame: 1 year
description: The relationship between the IgG levels and severity of the disease, age of recovered patients and duration of symptoms and viral clearance.
arm group label: Recovered COVID-19 patients
description: Patients recovered from COVID-19 infection within three months before the start of the study.
intervention type: Diagnostic Test
intervention name: IgG antibodies immunoassay
description: Assessment of IgG level will be done by quantitative assessment of IgG in the serum of recovered persons by Chemiluminescence Immunoassay (CLIA).
arm group label: Recovered COVID-19 patients
Blood samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Mahmoud A. Abd El Aty, Prof.
role: Study Director
affiliation: Assiut University- Faculty of Medicine
last name: Mariam T. Amin
role: Principal Investigator
affiliation: Assiut University- Faculty of Medicine
last name: Mariam T. Amin
phone: 00201064554080
email: mariam.amin015@gmail.com
facility: 
contact: 
country: Egypt
url: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/events-as-they-happen
description: Coronavirus: Events as they happen
url: https://www.worldometers.info/coronavirus/
description: Coronavirus Update (Live): Cases and Deaths from COVID-19 Virus Pandemic
citation: Li G, Fan Y, Lai Y, Han T, Li Z, Zhou P, Pan P, Wang W, Hu D, Liu X, Zhang Q, Wu J. Coronavirus infections and immune responses. J Med Virol. 2020 Apr;92(4):424-432. doi: 10.1002/jmv.25685. Epub 2020 Feb 7.
PMID: 31981224
citation: Singhal T. A Review of Coronavirus Disease-2019 (COVID-19). Indian J Pediatr. 2020 Apr;87(4):281-286. doi: 10.1007/s12098-020-03263-6. Epub 2020 Mar 13.
PMID: 32166607
citation: Long QX, Tang XJ, Shi QL, Li Q, Deng HJ, Yuan J, Hu JL, Xu W, Zhang Y, Lv FJ, Su K, Zhang F, Gong J, Wu B, Liu XM, Li JJ, Qiu JF, Chen J, Huang AL. Clinical and immunological assessment of asymptomatic SARS-CoV-2 infections. Nat Med. 2020 Aug;26(8):1200-1204. doi: 10.1038/s41591-020-0965-6. Epub 2020 Jun 18.
PMID: 32555424
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mariam T. Amin
investigator title: Assistant Lecturer
mesh term: COVID-19
mesh term: Antibodies
mesh term: Immunoglobulin G