<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/NCT04402853</url>
  </required_header>
  <id_info>
    <org_study_id>72/2020</org_study_id>
    <nct_id>NCT04402853</nct_id>
  </id_info>
  <brief_title>SARS Cov-2 in Conjunctival Secretion in COVID-19 Patients</brief_title>
  <official_title>SARS Cov-2 in Conjunctival Secretions in an Italian Lombardia Cohort of Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Università degli Studi dell'Insubria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Università degli Studi dell'Insubria</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>
      Observational study to evaluate the presence of SARS COV-2 in tears collected in COVID-19&#xD;
      patients in Lombardia region, northern Italy, and to correlate virus presence to concomitant&#xD;
      systemic clinical conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Since February 2020, Coronavirurus Disease 2019 associated to a severe acute respiratory&#xD;
      syndrome started in China and rapidly spread all over the world and in particular in northern&#xD;
      Italy. There are many reasons to justify this rapid diffusion in Italian Lombardia region as&#xD;
      the high population density with more possibilities of interpersonal contact, high prevalence&#xD;
      of respiratory pathologies, in particular in elderly people, due to pollution, high number of&#xD;
      contacts with Chinese population for travelling and business reasons, and at last the&#xD;
      non-windy temperate climate conditions, that increases the persistence of virus in the&#xD;
      environment.&#xD;
&#xD;
      At now, more than eighty thousand citizens from Lombardia Region have been officially&#xD;
      affected by the disease with a high death toll, also considering that actual numbers are&#xD;
      certainly much underestimated.&#xD;
&#xD;
      The aim of the present study was to evaluate the prevalence of SARS COV-2 virus in tears&#xD;
      collected from COVID-19 patients by rtPCR analysis directed to target sites of viral RNA, and&#xD;
      to correlate virus presence to concomitant systemic clinical conditions&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Actual">May 20, 2020</completion_date>
  <primary_completion_date type="Actual">March 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Virus presence in COVID 19 patients tears</measure>
    <time_frame>1 day</time_frame>
    <description>prevalence of SARS CoV 2 virus on tears</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concordance to Naso-Pharingeal Swab</measure>
    <time_frame>1 day</time_frame>
    <description>Evaluation of concordance with Naso-Pharingeal testing</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Sars-CoV2</condition>
  <condition>Tear</condition>
  <arm_group>
    <arm_group_label>COVID 19 Patients</arm_group_label>
    <description>hospitalized patients with COVID 19</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Tears swab</intervention_name>
    <description>rtPCR on tears swabs samples</description>
    <arm_group_label>COVID 19 Patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tears&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Hospitalized patients with a confirmed diagnosis of COVID 19 pneumonia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitalized COVID 19 patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with respiratory support that interferes with tears sampling&#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>Simone Donati, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Insubria, Varese</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ASST Sette Laghi</name>
      <address>
        <city>Varese</city>
        <zip>21100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <link>
    <url>https://www.healio.com/ophthalmology/cornea-external-disease/news/online/%7Bb388d413-6068-4ed7-8a29-f979d33ef1a0%7D/covid-19-possibly-identified-in-tears-conjunctival-secretions</url>
    <description>tears and infection</description>
  </link>
  <reference>
    <citation>Wu P, Duan F, Luo C, Liu Q, Qu X, Liang L, Wu K. Characteristics of Ocular Findings of Patients With Coronavirus Disease 2019 (COVID-19) in Hubei Province, China. JAMA Ophthalmol. 2020 May 1;138(5):575-578. doi: 10.1001/jamaophthalmol.2020.1291.</citation>
    <PMID>32232433</PMID>
  </reference>
  <results_reference>
    <citation>Hong N, Yu W, Xia J, Shen Y, Yap M, Han W. Evaluation of ocular symptoms and tropism of SARS-CoV-2 in patients confirmed with COVID-19. Acta Ophthalmol. 2020 Aug;98(5):e649-e655. doi: 10.1111/aos.14445. Epub 2020 Apr 26.</citation>
    <PMID>32336042</PMID>
  </results_reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>December 1, 2020</last_update_submitted>
  <last_update_submitted_qc>December 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Università degli Studi dell'Insubria</investigator_affiliation>
    <investigator_full_name>Simone Donati</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>COVID 19</keyword>
  <keyword>EYE</keyword>
  <keyword>Tears</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The study will be published</ipd_description>
  </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/NCT04402853
org study id: 72/2020
nct id: NCT04402853
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Observational study to evaluate the presence of SARS COV-2 in tears collected in COVID-19
      patients in Lombardia region, northern Italy, and to correlate virus presence to concomitant
      systemic clinical conditions.
Since February 2020, Coronavirurus Disease 2019 associated to a severe acute respiratory
      syndrome started in China and rapidly spread all over the world and in particular in northern
      Italy. There are many reasons to justify this rapid diffusion in Italian Lombardia region as
      the high population density with more possibilities of interpersonal contact, high prevalence
      of respiratory pathologies, in particular in elderly people, due to pollution, high number of
      contacts with Chinese population for travelling and business reasons, and at last the
      non-windy temperate climate conditions, that increases the persistence of virus in the
      environment.

      At now, more than eighty thousand citizens from Lombardia Region have been officially
      affected by the disease with a high death toll, also considering that actual numbers are
      certainly much underestimated.

      The aim of the present study was to evaluate the prevalence of SARS COV-2 virus in tears
      collected from COVID-19 patients by rtPCR analysis directed to target sites of viral RNA, and
      to correlate virus presence to concomitant systemic clinical conditions
observational model: Case-Crossover
time perspective: Prospective
measure: Virus presence in COVID 19 patients tears
time frame: 1 day
description: prevalence of SARS CoV 2 virus on tears
measure: Concordance to Naso-Pharingeal Swab
time frame: 1 day
description: Evaluation of concordance with Naso-Pharingeal testing
arm group label: COVID 19 Patients
description: hospitalized patients with COVID 19
intervention type: Diagnostic Test
intervention name: Tears swab
description: rtPCR on tears swabs samples
arm group label: COVID 19 Patients
Tears
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Simone Donati, Professor
role: Principal Investigator
affiliation: University of Insubria, Varese
facility: 
country: Italy
url: https://www.healio.com/ophthalmology/cornea-external-disease/news/online/%7Bb388d413-6068-4ed7-8a29-f979d33ef1a0%7D/covid-19-possibly-identified-in-tears-conjunctival-secretions
description: tears and infection
citation: Wu P, Duan F, Luo C, Liu Q, Qu X, Liang L, Wu K. Characteristics of Ocular Findings of Patients With Coronavirus Disease 2019 (COVID-19) in Hubei Province, China. JAMA Ophthalmol. 2020 May 1;138(5):575-578. doi: 10.1001/jamaophthalmol.2020.1291.
PMID: 32232433
citation: Hong N, Yu W, Xia J, Shen Y, Yap M, Han W. Evaluation of ocular symptoms and tropism of SARS-CoV-2 in patients confirmed with COVID-19. Acta Ophthalmol. 2020 Aug;98(5):e649-e655. doi: 10.1111/aos.14445. Epub 2020 Apr 26.
PMID: 32336042
responsible party type: Principal Investigator
investigator affiliation: Università degli Studi dell'Insubria
investigator full name: Simone Donati
investigator title: Associate Professor
sharing ipd: Undecided
ipd description: The study will be published