<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/NCT04466644</url>
  </required_header>
  <id_info>
    <org_study_id>IGX2-COV-JC-20-04</org_study_id>
    <secondary_id>20201490</secondary_id>
    <nct_id>NCT04466644</nct_id>
  </id_info>
  <brief_title>COVID-19: A Prevalence Study of Two ART Centres After the Pandemic Lockdown in the USA (COVID-19 Free Clinics)</brief_title>
  <official_title>A Multicenter, Prevalence Study to Evaluate the Infectious and Immunological Status of COVID-19 in Asymptomatic Subjects Attending ART Centres After the Pandemic Lockdown in the USA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Igenomix</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Igenomix</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>
      In late December 2019, a new coronavirus strain emerged causing coronavirus disease 2019&#xD;
      (COVID19). Since then, COVID19 has become a global pandemic outbreak being declared a &quot;public&#xD;
      health emergency of international concern&quot; by the International Health Regulations Emergency&#xD;
      Committee of the WHO on January 30, 2020. Several emergency measures have been implemented in&#xD;
      different countries such as lockdown, social distancing, and testing.&#xD;
&#xD;
      The pandemic concerns to public worldwide but also to couples aiming to conceive through&#xD;
      natural means or undergoing assisted reproductive technologies (ART). The American Society of&#xD;
      Reproductive Medicine (ASRM) as well as European Society of Human Reproduction and Embryology&#xD;
      (ESHRE) have recommend a precautionary approach and advise that all fertility patients&#xD;
      considering or planning treatment, even if they do not meet the diagnostic criteria for&#xD;
      COVID-19 infection, should avoid becoming pregnant at this time until more is known about the&#xD;
      virus. Therefore, new cycles for infertility patients as well as non-medically urgent gamete&#xD;
      preservation treatments, such as social egg freezing, have been suspended deferring embryo&#xD;
      transfer in those patients with initiated cycles. In this moment, when reopening phases are&#xD;
      being undertaken in most countries, the decision to resume the In vitro fertilization (IVF)&#xD;
      treatment in a safe environment to the healthcare workers and patients is the biggest concern&#xD;
      of the ART clinics.&#xD;
&#xD;
      The present study aims to describe the percentage of COVID-19 condition (naïve, immune, and&#xD;
      currently infected) in asymptomatic individuals from two different ART centres. For this&#xD;
      purpose, the ART centres' personnel and patients will be tested for COVID-19 before resume&#xD;
      the clinic daily routine just after the lockdown period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      On March 11th 2020, WHO characterized COVID-19 as a pandemic and on March 13th, the President&#xD;
      of the United States declared the COVID-19 outbreak a &quot;national emergency&quot;. In order to fight&#xD;
      this pandemic, emergency measures have been implemented in different countries such as&#xD;
      lockdown, social distancing and testing. It is known that these measures have differed among&#xD;
      countries and due to the lack of tests worldwide, the real number of affected and/or&#xD;
      immunized people remains largely unknown. In this context, the daily most important surrogate&#xD;
      markers have been the numbers of infected hospitalized and deceased population. However,&#xD;
      asymptomatic infections are not uncommon (representing up to 30% of infected cases) and the&#xD;
      detection of this population seems crucial to prevent their potential transmission and to&#xD;
      guide the development of measures to control the ongoing pandemic.&#xD;
&#xD;
      This is a descriptive, prevalence study that aims to define the current contagious risk and&#xD;
      immune status to SARS-CoV-2/COVID-19 infection in two reproduction health centers in the USA&#xD;
      located in Utah and Massachusetts. Aiming for the better technical procedures available,&#xD;
      different biological samples (nasopharyngeal swab, saliva, and blood sample) from each&#xD;
      participant will be tested applying two different methodologies already approved by Health&#xD;
      Authorities, and nowadays the most commonly used for the COVID-19 diagnose: Reverse&#xD;
      Transcriptase - Polymerase Chain Reaction (RT-PCR) for the analysis of the nasopharyngeal&#xD;
      swabs and saliva samples and Immunoassay by serology for the blood serum analysis.&#xD;
&#xD;
      A total of 400 participants, distributed equally between the two participant centers, are&#xD;
      expected to be included in 2 months.The total expected duration of the study is 4 months for&#xD;
      collecting, processing and analysing samples from participants (patients and clinical staff),&#xD;
      although the participation in the study will entail just a single visit (coinciding with the&#xD;
      same day of the samples collection). After that visit, no further interventions or follow-up&#xD;
      directly related to this study will be required.&#xD;
&#xD;
      Data exported from the clinical histories and source documents will be duly codified to&#xD;
      protect the clinical and personal information of patients in accordance with the current&#xD;
      legislation. This information will be exported to an electronic Case Report Form (eCRF) for&#xD;
      its analysis. Given the exceptional situation that the world is facing with the COVID-19&#xD;
      pandemic, U.S. authorities demand the report of all tested cases, so patient´s data will be&#xD;
      communicated to the U.S. national health authorities when the result of the test is positive.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 8, 2020</start_date>
  <completion_date type="Actual">August 25, 2020</completion_date>
  <primary_completion_date type="Actual">August 24, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of contagiousness in asymptomatic individuals by PCR with nasopharyngeal swabs</measure>
    <time_frame>2 months</time_frame>
    <description>Statistical quantification of the prevalence of contagiousness in asymptomatic individuals attending IVF clinics in the USA based on the gold standard test (PCR).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ratio of asymptomatic immunized (IgG) population</measure>
    <time_frame>2 months</time_frame>
    <description>Statistical quantification of the rate of immunized (IgG) individuals attending to IVF clinics in the USA based on the ELISA test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To validate saliva specimens as a biological sample for COVID-19 testing</measure>
    <time_frame>2 months</time_frame>
    <description>To validate the use of saliva specimen as a possible substitute to nasopharyngeal swabs, offering a simpler, easily self-sampling and large-scale test.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Description of demographic characteristics</measure>
    <time_frame>2 months</time_frame>
    <description>Age, gender and location distribution of affected contagious individuals in two areas of the USA with different pandemic status.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">340</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>The regulars of IVF clinics in the USA</arm_group_label>
    <description>Mainly asymptomatic individuals composed by patients who are attending their regular medical consultation and/ clinic staff of the participant sites, located in two areas of the USA with different pandemic status, and undergoing PCR and ELISA tests for diagnosis of COVID-19 before initiating the work after the lockdown.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ELISA</intervention_name>
    <description>Antibody test (serology) in the blood samples to determine if the subject was previously infected.</description>
    <arm_group_label>The regulars of IVF clinics in the USA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>RT-PCR</intervention_name>
    <description>For detecting the presence of SARS-CoV-2 RNA molecule in the nasopharyngeal swabs and saliva.</description>
    <arm_group_label>The regulars of IVF clinics in the USA</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      -  Blood&#xD;
&#xD;
        -  Saliva&#xD;
&#xD;
        -  Nasopharyngeal swab&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Mainly asymptomatic subjects composed by patients who are attending for their regular&#xD;
        medical consultation and clinic staff for COVID-19 infection from the two participant&#xD;
        sites, located in two areas with different pandemic status, before initiating the work&#xD;
        immediately after the lockdown period.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age of majority subjects whose written informed consent approved by the IRB has been&#xD;
             obtained, after having been duly informed of the nature of the study and voluntarily&#xD;
             accepted to participate after being fully aware of the potential risks, benefits and&#xD;
             any discomfort involved.&#xD;
&#xD;
          -  Site staff who are re-incorporating to the centers and patients who are attending&#xD;
             their medical appointment for their regular IVF treatment.&#xD;
&#xD;
          -  Mainly asymptomatic individuals from the ART clinics, before initiating the work right&#xD;
             after the lockdown period.&#xD;
&#xD;
        Note: COVID-19 symptomatology may appear 2-14 days after exposure to the virus and may&#xD;
        include at least one of the following symptoms:&#xD;
&#xD;
          -  Fever&#xD;
&#xD;
          -  Cough&#xD;
&#xD;
          -  Shortness of breath or difficulty breathing&#xD;
&#xD;
          -  Chills&#xD;
&#xD;
          -  Repeated shaking with chills&#xD;
&#xD;
          -  Muscle pain&#xD;
&#xD;
          -  Headache&#xD;
&#xD;
          -  Sore throat&#xD;
&#xD;
          -  New loss of taste or smell&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Not applicable as there is not exclusion criteria for this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juliana Cuzzi, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Igenomix</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carlos Simon, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Igenomix</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston IVF Fertility Clinic</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Utah Fertility Clinic</name>
      <address>
        <city>Pleasant Grove</city>
        <state>Utah</state>
        <zip>84062</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>September 10, 2020</last_update_submitted>
  <last_update_submitted_qc>September 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SARS-CoV-2</keyword>
  <keyword>Severe acute respiratory syndrome coronavirus 2</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>
  <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/NCT04466644
org study id: IGX2-COV-JC-20-04
secondary id: 20201490
nct id: NCT04466644
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In late December 2019, a new coronavirus strain emerged causing coronavirus disease 2019
      (COVID19). Since then, COVID19 has become a global pandemic outbreak being declared a "public
      health emergency of international concern" by the International Health Regulations Emergency
      Committee of the WHO on January 30, 2020. Several emergency measures have been implemented in
      different countries such as lockdown, social distancing, and testing.

      The pandemic concerns to public worldwide but also to couples aiming to conceive through
      natural means or undergoing assisted reproductive technologies (ART). The American Society of
      Reproductive Medicine (ASRM) as well as European Society of Human Reproduction and Embryology
      (ESHRE) have recommend a precautionary approach and advise that all fertility patients
      considering or planning treatment, even if they do not meet the diagnostic criteria for
      COVID-19 infection, should avoid becoming pregnant at this time until more is known about the
      virus. Therefore, new cycles for infertility patients as well as non-medically urgent gamete
      preservation treatments, such as social egg freezing, have been suspended deferring embryo
      transfer in those patients with initiated cycles. In this moment, when reopening phases are
      being undertaken in most countries, the decision to resume the In vitro fertilization (IVF)
      treatment in a safe environment to the healthcare workers and patients is the biggest concern
      of the ART clinics.

      The present study aims to describe the percentage of COVID-19 condition (naïve, immune, and
      currently infected) in asymptomatic individuals from two different ART centres. For this
      purpose, the ART centres' personnel and patients will be tested for COVID-19 before resume
      the clinic daily routine just after the lockdown period.
On March 11th 2020, WHO characterized COVID-19 as a pandemic and on March 13th, the President
      of the United States declared the COVID-19 outbreak a "national emergency". In order to fight
      this pandemic, emergency measures have been implemented in different countries such as
      lockdown, social distancing and testing. It is known that these measures have differed among
      countries and due to the lack of tests worldwide, the real number of affected and/or
      immunized people remains largely unknown. In this context, the daily most important surrogate
      markers have been the numbers of infected hospitalized and deceased population. However,
      asymptomatic infections are not uncommon (representing up to 30% of infected cases) and the
      detection of this population seems crucial to prevent their potential transmission and to
      guide the development of measures to control the ongoing pandemic.

      This is a descriptive, prevalence study that aims to define the current contagious risk and
      immune status to SARS-CoV-2/COVID-19 infection in two reproduction health centers in the USA
      located in Utah and Massachusetts. Aiming for the better technical procedures available,
      different biological samples (nasopharyngeal swab, saliva, and blood sample) from each
      participant will be tested applying two different methodologies already approved by Health
      Authorities, and nowadays the most commonly used for the COVID-19 diagnose: Reverse
      Transcriptase - Polymerase Chain Reaction (RT-PCR) for the analysis of the nasopharyngeal
      swabs and saliva samples and Immunoassay by serology for the blood serum analysis.

      A total of 400 participants, distributed equally between the two participant centers, are
      expected to be included in 2 months.The total expected duration of the study is 4 months for
      collecting, processing and analysing samples from participants (patients and clinical staff),
      although the participation in the study will entail just a single visit (coinciding with the
      same day of the samples collection). After that visit, no further interventions or follow-up
      directly related to this study will be required.

      Data exported from the clinical histories and source documents will be duly codified to
      protect the clinical and personal information of patients in accordance with the current
      legislation. This information will be exported to an electronic Case Report Form (eCRF) for
      its analysis. Given the exceptional situation that the world is facing with the COVID-19
      pandemic, U.S. authorities demand the report of all tested cases, so patient´s data will be
      communicated to the U.S. national health authorities when the result of the test is positive.
observational model: Other
time perspective: Prospective
measure: Prevalence of contagiousness in asymptomatic individuals by PCR with nasopharyngeal swabs
time frame: 2 months
description: Statistical quantification of the prevalence of contagiousness in asymptomatic individuals attending IVF clinics in the USA based on the gold standard test (PCR).
measure: Ratio of asymptomatic immunized (IgG) population
time frame: 2 months
description: Statistical quantification of the rate of immunized (IgG) individuals attending to IVF clinics in the USA based on the ELISA test.
measure: To validate saliva specimens as a biological sample for COVID-19 testing
time frame: 2 months
description: To validate the use of saliva specimen as a possible substitute to nasopharyngeal swabs, offering a simpler, easily self-sampling and large-scale test.
measure: Description of demographic characteristics
time frame: 2 months
description: Age, gender and location distribution of affected contagious individuals in two areas of the USA with different pandemic status.
arm group label: The regulars of IVF clinics in the USA
description: Mainly asymptomatic individuals composed by patients who are attending their regular medical consultation and/ clinic staff of the participant sites, located in two areas of the USA with different pandemic status, and undergoing PCR and ELISA tests for diagnosis of COVID-19 before initiating the work after the lockdown.
intervention type: Diagnostic Test
intervention name: ELISA
description: Antibody test (serology) in the blood samples to determine if the subject was previously infected.
arm group label: The regulars of IVF clinics in the USA
intervention type: Diagnostic Test
intervention name: RT-PCR
description: For detecting the presence of SARS-CoV-2 RNA molecule in the nasopharyngeal swabs and saliva.
arm group label: The regulars of IVF clinics in the USA
-  Blood

        -  Saliva

        -  Nasopharyngeal swab
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Juliana Cuzzi, PhD
role: Principal Investigator
affiliation: Igenomix
last name: Carlos Simon, MD, PhD
role: Principal Investigator
affiliation: Igenomix
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No