<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/NCT04409184</url>
  </required_header>
  <id_info>
    <org_study_id>PRO00037957</org_study_id>
    <nct_id>NCT04409184</nct_id>
  </id_info>
  <brief_title>Whole Blood Collection From Individuals in the Convalescent Phase of SARS-CoV-2 Infection</brief_title>
  <official_title>Evaluation of Whole Blood Samples From Coronavirus Disease 2019 (COVID-19) Convalescent Patients to Study Immune Response and Severity of Disease Predictors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical College of Wisconsin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Versiti</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical College of Wisconsin</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>
      The study was not opened.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study was not opened.&#xD;
  </why_stopped>
  <start_date type="Actual">August 14, 2020</start_date>
  <completion_date type="Actual">August 14, 2020</completion_date>
  <primary_completion_date type="Actual">August 14, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Characterization of specific T cell responses in peripheral blood isolated from patients that have been exposed to SARS-CoV-2.</measure>
    <time_frame>Up to 1 year post infection.</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>COVID</condition>
  <condition>Sars-CoV2</condition>
  <arm_group>
    <arm_group_label>Convalescent subjects</arm_group_label>
    <description>Convalescent, now asymptomatic, subjects with documented prior COVID-19 due to SARS-CoV-2 infection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy controls</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals cared for at Froedtert Hospital, Milwaukee, Wisconsin who meet the inclusion&#xD;
        and exclusion criteria as outlined.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients who have previously been diagnosed with COVID-19 but are now asymptomatic &gt;14 days&#xD;
        and a matched number of healthy controls:&#xD;
&#xD;
          1. Consent: Subject able to provide voluntary written consent before performance of any&#xD;
             study-related procedure not part of normal medical care, with the understanding that&#xD;
             consent may be withdrawn by the subject at any time without prejudice to future&#xD;
             medical care.&#xD;
&#xD;
          2. SARS-CoV-2 Testing Status:&#xD;
&#xD;
               1. Experimental Population: Subject has had positive SARS-CoV-2 verified by clinical&#xD;
                  laboratory OR&#xD;
&#xD;
               2. Control Population: Subject without testing or negative SARS-CoV-2 testing&#xD;
&#xD;
          3. Complete resolution and current absence of clinical symptoms Symptoms Defined as:&#xD;
             Fever, Dry cough, Fatigue, Difficulty breathing, Sore throat, Diarrhea, Rhinorrhea&#xD;
             (runny nose), or new aches/pains.&#xD;
&#xD;
          4. Age: Greater or equal to 18 years of age. a. Subject must be able to provide voluntary&#xD;
             written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Ongoing symptoms of COVID19 due to SARS-CoV-2 infection&#xD;
&#xD;
             a. Symptoms Defined as: Fever, Dry cough, Fatigue, Difficulty breathing, Sore throat,&#xD;
             Diarrhea, Rhinorrhea (runny nose), or new aches/pains.&#xD;
&#xD;
          2. Ongoing symptoms not due or not known to be due to SARS-CoV-2 infection&#xD;
&#xD;
             a. Symptoms Defined as: Fever, Dry cough, Fatigue, Difficulty breathing, Sore throat,&#xD;
             Diarrhea, Rhinorrhea (runny nose), or new aches/pains.&#xD;
&#xD;
          3. Patients receiving ongoing medical symptomatic treatment or prophylaxis treatment&#xD;
             related to COVID-19 due to SARS-CoV-2&#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>
  <verification_date>August 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>August 14, 2020</last_update_submitted>
  <last_update_submitted_qc>August 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical College of Wisconsin</investigator_affiliation>
    <investigator_full_name>Weiguo Cui</investigator_full_name>
    <investigator_title>Associate Professor, Microbiology &amp; Immunology</investigator_title>
  </responsible_party>
  <!-- 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/NCT04409184
org study id: PRO00037957
nct id: NCT04409184
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The study was not opened.
observational model: Cohort
time perspective: Retrospective
measure: Characterization of specific T cell responses in peripheral blood isolated from patients that have been exposed to SARS-CoV-2.
time frame: Up to 1 year post infection.
arm group label: Convalescent subjects
description: Convalescent, now asymptomatic, subjects with documented prior COVID-19 due to SARS-CoV-2 infection
arm group label: Healthy controls
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Medical College of Wisconsin
investigator full name: Weiguo Cui
investigator title: Associate Professor, Microbiology & Immunology