<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/NCT04431414</url>
  </required_header>
  <id_info>
    <org_study_id>CoVPN 5001</org_study_id>
    <secondary_id>5UM1AI068614-14</secondary_id>
    <nct_id>NCT04431414</nct_id>
  </id_info>
  <brief_title>A Study of Immune Responses to the Virus That Causes COVID-19</brief_title>
  <acronym>CoVPN 5001</acronym>
  <official_title>A Prospective Study of Acute Immune Responses to SARSCoV-2 Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>COVID-19 Prevention Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>COVID-19 Prevention Network</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>
      The purpose of this study is to learn more about the acute response to infection with and&#xD;
      recovery from the virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).&#xD;
      Some people know this virus by the name &quot;coronavirus.&quot; It can cause the disease called&#xD;
      COVID-19.&#xD;
&#xD;
      The information gained from the study can be used to help develop better tests for SARS-CoV-2&#xD;
      infection and COVID-19 disease and may help in developing future vaccines, other prevention&#xD;
      strategies, and treatments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective study of acute immune responses to SARSCoV-2 infection.&#xD;
&#xD;
      The study will include 3 groups, as described in the table below. Groups are defined based on&#xD;
      clinical status at enrollment, but for the purposes of data analysis, participants who&#xD;
      experience disease progression can contribute data to other cohorts.&#xD;
&#xD;
      Participants will complete six visits over 28 days followed by a health contact at Month 2&#xD;
      (one month after the last scheduled visit). Additional follow up visit(s) may be added over&#xD;
      time in response to evolving information regarding SARS-CoV-2 infection and COVID-19.&#xD;
&#xD;
      Study visits may include review of medical history; interviews/questionnaires; pregnancy&#xD;
      tests (for participants assigned female sex at birth); blood draws; nasal swab, nasal wash,&#xD;
      and saliva sample collection; and optional stool sample collection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Actual">June 2, 2022</completion_date>
  <primary_completion_date type="Actual">June 2, 2022</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>Response rate of SARS-CoV-2-specific B cells in peripheral blood samples</measure>
    <time_frame>Measured through day 14</time_frame>
    <description>Characterized using fluorescently labeled recombinant proteins in combination with a flow cytometry phenotyping panel</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Magnitude of SARS-CoV-2-specific B cells in peripheral blood samples</measure>
    <time_frame>Measured through day 14</time_frame>
    <description>Characterized using fluorescently labeled recombinant proteins in combination with a flow cytometry phenotyping panel</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phenotypic characterization of SARS-CoV-2-specific B cells in peripheral blood samples</measure>
    <time_frame>Measured through day 14</time_frame>
    <description>Characterized using fluorescently labeled recombinant proteins in combination with a flow cytometry phenotyping panel</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Response rate of SARS-CoV-2-specific antibody binding in serum samples</measure>
    <time_frame>Measured through day 28</time_frame>
    <description>Measured by binding antibody multiplex assay (BAMA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Response rate of SARS-CoV-2-specific neutralizing antibodies in serum samples</measure>
    <time_frame>Measured through day 28</time_frame>
    <description>Measured by neutralizing antibody assay (nAb)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Magnitude of SARS-CoV-2-specific antibody binding antibodies in serum samples</measure>
    <time_frame>Measured through day 28</time_frame>
    <description>Measured by binding antibody multiplex assay (BAMA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Magnitude of SARS-CoV-2-specific neutralizing antibodies in serum samples</measure>
    <time_frame>Measured through day 28</time_frame>
    <description>Measured by neutralizing antibody assay (nAb)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Response rate of SARS-CoV-2-specific binding antibodies in nasal wash samples</measure>
    <time_frame>Measured through day 28</time_frame>
    <description>Measured by binding antibody multiplex assay (BAMA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Magnitude of SARS-CoV-2-specific binding antibodies in nasal wash samples</measure>
    <time_frame>Measured through day 28</time_frame>
    <description>Measured by binding antibody multiplex assay (BAMA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of leukocyte populations in peripheral blood</measure>
    <time_frame>Measured through day 14</time_frame>
    <description>Measured by flow cytometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Transcriptional profiles of peripheral blood leukocytes</measure>
    <time_frame>Measured through day 14</time_frame>
    <description>Measured by gene expression analysis by RNA sequencing, real-time PCR, single-cell proteogenomic profiling</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentration of serum cytokines and other soluble factors</measure>
    <time_frame>Measured through day 28</time_frame>
    <description>Measured by multiplexed protein detection assays and/or enzyme-linked immunosorbent assays (ELISA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Response rate of SARS-CoV-2-specific CD4+ and CD8+ T cells</measure>
    <time_frame>Measured through day 28</time_frame>
    <description>Measured by flow cytometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Magnitude of SARS-CoV-2-specific CD4+ and CD8+ T cells</measure>
    <time_frame>Measured through day 28</time_frame>
    <description>Measured by flow cytometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional profiling, including intracellular cytokine staining, of SARS-CoV-2-specific CD4+ and CD8+ T cells</measure>
    <time_frame>Measured through day 28</time_frame>
    <description>Measured by flow cytometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quantitation of viral RNA in nasal swabs</measure>
    <time_frame>Measured through day 28</time_frame>
    <description>Measured by extraction of nucleic acid for analysis of microorganism RNA or DNA by qPCR and/or amplicon- or metagenomics-sequencing methods and subsequent gene and taxa-level bioinformatics analyses</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">953</enrollment>
  <condition>SARS-CoV-2</condition>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Persons that are positive for SARS-CoV-2 and are asymptomatic</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>Persons that are positive for SARS-CoV-2 with recent onset of mild symptoms (not hospitalized)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <description>Persons that are positive for SARS-CoV-2 and are symptomatic hospitalized patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sample collection</intervention_name>
    <description>blood, nasal swab, nasal wash, and saliva&#xD;
optional stool swab</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants who have tested positive for SARSCoV-2 virus by RT-PCR or antigen testing.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older.&#xD;
&#xD;
          -  Test result indicating presence of SARS-CoV-2 virus. Sites must have results from&#xD;
             assays that are approved as FDA-emergency use authorized or as standard-of-care by&#xD;
             other applicable regional governing bodies. For timing of testing, please see group&#xD;
             specific criteria below.&#xD;
&#xD;
          -  Ability and willingness to provide informed consent.&#xD;
&#xD;
          -  Willingness to have clinical research staff come to place of residence or hospital if&#xD;
             needed.&#xD;
&#xD;
          -  Willingness to be followed for the planned duration of the study.&#xD;
&#xD;
          -  Assessment of understanding: volunteer demonstrates understanding of this study.&#xD;
&#xD;
          -  Agreement to allow access to medical records.&#xD;
&#xD;
          -  Asymptomatic participants:&#xD;
&#xD;
               -  No current symptoms.&#xD;
&#xD;
               -  No symptoms consistent with COVID-19 within 2 weeks prior to positive test&#xD;
                  according to the clinical judgement of the investigating clinician. Symptoms&#xD;
                  include, but are not limited to, fever, headache, sore throat, cough, dyspnea,&#xD;
                  rhinorrhea, diarrhea, myalgias, chills, and anosmia. Please refer to&#xD;
                  https://www.cdc.gov/coronavirus/2019-ncov/symptomstesting/symptoms.html for the&#xD;
                  current list of symptoms consistent with COVID-19.&#xD;
&#xD;
               -  Positive SARS-CoV-2 RNA test or antigen test within six days prior to enrollment&#xD;
                  (target time) up to 10 days prior to enrollment (upper allowable window).&#xD;
&#xD;
          -  Symptomatic (non-hospitalized) participants:&#xD;
&#xD;
               -  Onset of mild symptoms consistent with COVID-19 within 6 days prior to enrollment&#xD;
                  (target time) up to 14 days prior to enrollment (upper allowable window).&#xD;
                  Symptoms of COVID-19 to be determined by the clinical judgement of the&#xD;
                  investigating clinician including-- but not limited to-- fever, headache, sore&#xD;
                  throat, cough, dyspnea, rhinorrhea, diarrhea myalgias, chills, and anosmia.&#xD;
                  Please refer to&#xD;
                  https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html for the&#xD;
                  current list of symptoms consistent with COVID-19.&#xD;
&#xD;
               -  Positive SARS-CoV-2 RNA test or antigen test within six days prior to enrollment&#xD;
                  (target time) up to 10 days prior to enrollment (upper allowable window).&#xD;
&#xD;
          -  Symptomatic (hospitalized) participants&#xD;
&#xD;
               -  Participant hospitalized for COVID-19 within 3 days prior to enrollment (note:&#xD;
                  there is no timeframe for either symptom onset or timing of SARS-CoV-2 PCR or&#xD;
                  antigen testing for hospitalized participants)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any medical, psychiatric, occupational, or other condition that, in the judgment of&#xD;
             the investigator, would interfere with, or serve as a contraindication to, protocol&#xD;
             adherence or a volunteer's ability to give informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Will Hahn</last_name>
    <role>Study Chair</role>
    <affiliation>Fred Hutch</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amy Ward</last_name>
    <role>Study Chair</role>
    <affiliation>Cape Town - Khayelitsha</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alabama CRS</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bridge HIV CRS</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami Infectious Disease Research Unit at Jackson Memorial Hospital CRS</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ponce de Leon Center CRS</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Hope Clinic of the Emory Vaccine Center CRS</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Orleans Adolescent Trials Unit CRS</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University CRS</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital Vaccine CRS (BWH VCRS)</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Jersey Medical School Clinical Research Center CRS</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia P&amp;S CRS</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Blood Center CRS</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chapel Hill CRS</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Case CRS</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn Prevention CRS</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Vaccine and Prevention CRS</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion Huesped CRS</name>
      <address>
        <city>Buenos Aires</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Agudos JM Ramos Mejía CRS</name>
      <address>
        <city>Buenos Aires</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gaborone CRS</name>
      <address>
        <city>Gaborone</city>
        <country>Botswana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SOM Federal University Minas Gerais Brazil NICHD CRS</name>
      <address>
        <city>Belo Horizonte</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS</name>
      <address>
        <city>Rio de Janeiro</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Malawi CRS</name>
      <address>
        <city>Lilongwe</city>
        <country>Malawi</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Merida CRS</name>
      <address>
        <city>Mérida</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CITBM - UNIDEC, Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS</name>
      <address>
        <city>Bellavista</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asociacion Civil Selva Amazonica (ASCA) CRS</name>
      <address>
        <city>Iquitos</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barranco CRS</name>
      <address>
        <city>Lima</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Miguel CRS</name>
      <address>
        <city>Lima</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groote Schuur HIV CRS</name>
      <address>
        <city>Cape Town</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Khayelitsha CRS / (CIDRI UCT)</name>
      <address>
        <city>Cape Town</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Masiphumelele Clinical Research Site (MASI) CRS</name>
      <address>
        <city>Cape Town</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chatsworth CRS</name>
      <address>
        <city>Chatsworth</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Botha's Hill CRS</name>
      <address>
        <city>Durban</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAPRISA eThekwini CRS</name>
      <address>
        <city>Durban</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vulindlela CRS</name>
      <address>
        <city>Durban</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ndlovu Research Centre CoVPN CRS</name>
      <address>
        <city>Elandsdoorn</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Isipingo CRS</name>
      <address>
        <city>Isipingo</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kliptown Soweto CRS</name>
      <address>
        <city>Johannesburg</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soweto HVTN CRS</name>
      <address>
        <city>Johannesburg</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurum Institute Klerksdorp CRS</name>
      <address>
        <city>Klerksdorp</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qhakaza Mbokodo Research Clinic CRS</name>
      <address>
        <city>Ladysmith</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MeCRU CRS</name>
      <address>
        <city>Medunsa</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nelson Mandela Academic Research Unit CRS</name>
      <address>
        <city>Mthatha</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rustenburg CRS</name>
      <address>
        <city>Rustenburg</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Setshaba Research Centre CRS</name>
      <address>
        <city>Soshanguve</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tembisa Clinic 4 CoVPN CRS</name>
      <address>
        <city>Tembisa</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tongaat CRS</name>
      <address>
        <city>Tongaat</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Institute for Medical Research (NIMR) - Mbeya Medical Research Center (MMRC) Network CRS</name>
      <address>
        <city>Mbeya</city>
        <country>Tanzania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Matero Reference Clinic CRS</name>
      <address>
        <city>Lusaka</city>
        <country>Zambia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zambia Emory HIV Research Project - Lusaka CoVPN CRS</name>
      <address>
        <city>Lusaka</city>
        <country>Zambia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zambia Emory HIV Research Project - Ndola CoVPN CRS</name>
      <address>
        <city>Ndola</city>
        <country>Zambia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Mary's CRS</name>
      <address>
        <city>Chitungwiza</city>
        <country>Zimbabwe</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Milton Park CRS</name>
      <address>
        <city>Harare</city>
        <country>Zimbabwe</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seke South CRS</name>
      <address>
        <city>Harare</city>
        <country>Zimbabwe</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Botswana</country>
    <country>Brazil</country>
    <country>Malawi</country>
    <country>Mexico</country>
    <country>Peru</country>
    <country>South Africa</country>
    <country>Tanzania</country>
    <country>United States</country>
    <country>Zambia</country>
    <country>Zimbabwe</country>
  </location_countries>
  <removed_countries>
    <country>Kenya</country>
    <country>Mozambique</country>
  </removed_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>July 22, 2022</last_update_submitted>
  <last_update_submitted_qc>July 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>June 9, 2023</submitted>
    <returned>June 28, 2023</returned>
    <submitted>July 20, 2023</submitted>
    <returned>August 10, 2023</returned>
  </pending_results>
  <!-- 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/NCT04431414
org study id: CoVPN 5001
secondary id: 5UM1AI068614-14
nct id: NCT04431414
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to learn more about the acute response to infection with and
      recovery from the virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
      Some people know this virus by the name "coronavirus." It can cause the disease called
      COVID-19.

      The information gained from the study can be used to help develop better tests for SARS-CoV-2
      infection and COVID-19 disease and may help in developing future vaccines, other prevention
      strategies, and treatments.
This is a prospective study of acute immune responses to SARSCoV-2 infection.

      The study will include 3 groups, as described in the table below. Groups are defined based on
      clinical status at enrollment, but for the purposes of data analysis, participants who
      experience disease progression can contribute data to other cohorts.

      Participants will complete six visits over 28 days followed by a health contact at Month 2
      (one month after the last scheduled visit). Additional follow up visit(s) may be added over
      time in response to evolving information regarding SARS-CoV-2 infection and COVID-19.

      Study visits may include review of medical history; interviews/questionnaires; pregnancy
      tests (for participants assigned female sex at birth); blood draws; nasal swab, nasal wash,
      and saliva sample collection; and optional stool sample collection.
observational model: Cohort
time perspective: Prospective
measure: Response rate of SARS-CoV-2-specific B cells in peripheral blood samples
time frame: Measured through day 14
description: Characterized using fluorescently labeled recombinant proteins in combination with a flow cytometry phenotyping panel
measure: Magnitude of SARS-CoV-2-specific B cells in peripheral blood samples
time frame: Measured through day 14
description: Characterized using fluorescently labeled recombinant proteins in combination with a flow cytometry phenotyping panel
measure: Phenotypic characterization of SARS-CoV-2-specific B cells in peripheral blood samples
time frame: Measured through day 14
description: Characterized using fluorescently labeled recombinant proteins in combination with a flow cytometry phenotyping panel
measure: Response rate of SARS-CoV-2-specific antibody binding in serum samples
time frame: Measured through day 28
description: Measured by binding antibody multiplex assay (BAMA)
measure: Response rate of SARS-CoV-2-specific neutralizing antibodies in serum samples
time frame: Measured through day 28
description: Measured by neutralizing antibody assay (nAb)
measure: Magnitude of SARS-CoV-2-specific antibody binding antibodies in serum samples
time frame: Measured through day 28
description: Measured by binding antibody multiplex assay (BAMA)
measure: Magnitude of SARS-CoV-2-specific neutralizing antibodies in serum samples
time frame: Measured through day 28
description: Measured by neutralizing antibody assay (nAb)
measure: Response rate of SARS-CoV-2-specific binding antibodies in nasal wash samples
time frame: Measured through day 28
description: Measured by binding antibody multiplex assay (BAMA)
measure: Magnitude of SARS-CoV-2-specific binding antibodies in nasal wash samples
time frame: Measured through day 28
description: Measured by binding antibody multiplex assay (BAMA)
measure: Frequency of leukocyte populations in peripheral blood
time frame: Measured through day 14
description: Measured by flow cytometry
measure: Transcriptional profiles of peripheral blood leukocytes
time frame: Measured through day 14
description: Measured by gene expression analysis by RNA sequencing, real-time PCR, single-cell proteogenomic profiling
measure: Concentration of serum cytokines and other soluble factors
time frame: Measured through day 28
description: Measured by multiplexed protein detection assays and/or enzyme-linked immunosorbent assays (ELISA)
measure: Response rate of SARS-CoV-2-specific CD4+ and CD8+ T cells
time frame: Measured through day 28
description: Measured by flow cytometry
measure: Magnitude of SARS-CoV-2-specific CD4+ and CD8+ T cells
time frame: Measured through day 28
description: Measured by flow cytometry
measure: Functional profiling, including intracellular cytokine staining, of SARS-CoV-2-specific CD4+ and CD8+ T cells
time frame: Measured through day 28
description: Measured by flow cytometry
measure: Quantitation of viral RNA in nasal swabs
time frame: Measured through day 28
description: Measured by extraction of nucleic acid for analysis of microorganism RNA or DNA by qPCR and/or amplicon- or metagenomics-sequencing methods and subsequent gene and taxa-level bioinformatics analyses
arm group label: Group 1
description: Persons that are positive for SARS-CoV-2 and are asymptomatic
arm group label: Group 2
description: Persons that are positive for SARS-CoV-2 with recent onset of mild symptoms (not hospitalized)
arm group label: Group 3
description: Persons that are positive for SARS-CoV-2 and are symptomatic hospitalized patients
intervention type: Other
intervention name: Sample collection
description: blood, nasal swab, nasal wash, and saliva
optional stool swab
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Will Hahn
role: Study Chair
affiliation: Fred Hutch
last name: Amy Ward
role: Study Chair
affiliation: Cape Town - Khayelitsha
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country: Argentina
country: Botswana
country: Brazil
country: Malawi
country: Mexico
country: Peru
country: South Africa
country: Tanzania
country: United States
country: Zambia
country: Zimbabwe
country: Kenya
country: Mozambique
responsible party type: Sponsor
mesh term: COVID-19
submitted: June 9, 2023
returned: June 28, 2023
submitted: July 20, 2023
returned: August 10, 2023