<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/NCT04411147</url>
  </required_header>
  <id_info>
    <org_study_id>200123</org_study_id>
    <secondary_id>20-I-0123</secondary_id>
    <nct_id>NCT04411147</nct_id>
  </id_info>
  <brief_title>A Longitudinal Study of COVID-19 Sequelae and Immunity</brief_title>
  <official_title>A Longitudinal Study of COVID-19 Sequelae and Immunity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</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>
      Background:&#xD;
&#xD;
      COVID-19 is a disease caused by the SARS-CoV-2 virus. It infects the respiratory tract. Some&#xD;
      people who get COVID-19 have only mild symptoms. But for others, infection leads to&#xD;
      pneumonia, respiratory failure, and, in some cases, death. Researchers want to learn more&#xD;
      about any effects that may persist after people recover from COVID-19.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To learn about any long-term medical problems that people who have recovered from COVID-19&#xD;
      might have, and whether they develop an immune response to SARS-CoV-2 that provides&#xD;
      protection against reinfection.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      People age 18 and older who have recovered from documented COVID-19 or were in close contact&#xD;
      with someone who had COVID-19 but did not get the infection&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Participants will be screened over 2 visits. During visit 1, they will answer questions about&#xD;
      any symptoms they are having and will be tested for SARS-CoV-2 infection which will involve a&#xD;
      nasal swab sample or other FDA approved test. If the test is negative, they will proceed to&#xD;
      the second visit, which will include:&#xD;
&#xD;
      Physical examination&#xD;
&#xD;
      Medical history&#xD;
&#xD;
      Mental health interview (which may be recorded if the participant agrees)&#xD;
&#xD;
      Chest x-ray (for recovered COVID-19 participants only)&#xD;
&#xD;
      Blood and urine tests&#xD;
&#xD;
      Pregnancy test (if needed)&#xD;
&#xD;
      Lung function test (for recovered COVID-19 participants only)&#xD;
&#xD;
      6-minute walk test (for recovered COVID-19 participants only)&#xD;
&#xD;
      Questionnaires about their general and mental health&#xD;
&#xD;
      Leukapheresis to collect white blood cells (optional).&#xD;
&#xD;
      Participants will be put into 1 of 2 groups: the COVID-19 group or the close contact group.&#xD;
&#xD;
      Participants will have study visits every 6 months for 3 years. They will repeat some of the&#xD;
      screening tests. Participants in the COVID-19 group may have visits more often if they&#xD;
      develop symptoms that suggest re-infection with SARS-CoV-2....&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Description:&#xD;
&#xD;
      This is a longitudinal cohort study to evaluate the clinical sequelae of acute COVID-19 and&#xD;
      characterize the immune response to SARS-CoV-2. Household contacts of the COVID-19 cohort&#xD;
      will also be recruited and serve as a control group.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        -  Characterize the medical sequalae and persistent symptoms following recovery from&#xD;
           COVID-19 in a cohort of disease survivors.&#xD;
&#xD;
        -  Estimate the incidence and risk factors for post-COVID-19 medical sequalae.&#xD;
&#xD;
        -  Characterize antibody and cell-mediated immune responses to SARS-CoV- 2 in disease&#xD;
           survivors&#xD;
&#xD;
        -  Characterize evolution of the antibody and T cell-mediated responses to SARS-CoV-2 in&#xD;
           survivors over time&#xD;
&#xD;
        -  Evaluate survivors for evidence of re-infection with future waves of COVID-19 to&#xD;
           determine if initial infection confers long-term protective immunity&#xD;
&#xD;
        -  Determine the incidence of clinically silent infection in household contacts&#xD;
&#xD;
        -  Characterize the mental health status of survivors and controls including medical trauma&#xD;
           related sequelae&#xD;
&#xD;
      Endpoint:&#xD;
&#xD;
      Establish a clinically well characterized cohort of persons recovered from COVID-19 and close&#xD;
      contacts of persons with COVID-19&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 17, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2027</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2027</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>Risk Factors for Medical Sequelae in COVID-19 Survivors</measure>
    <time_frame>Screening-Month 36</time_frame>
    <description>Estimate the incidence and risk factors for post-COVID-19 medical sequalae.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mental health status in COVID-19 survivors and contacts</measure>
    <time_frame>Screening-Month 36</time_frame>
    <description>Characterize the mental health status of survivors and controls including medical trauma related sequelae</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medical Sequelae in COVID-19 Survivors</measure>
    <time_frame>Screening-Month 36</time_frame>
    <description>Characterize the medical sequelae and persistent symptoms following recovery from COVID-19 in a cohort of disease survivors.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of reinfection with COVID-19</measure>
    <time_frame>Screening-Month 36</time_frame>
    <description>Evaluate survivors for evidence of re-infection with future waves of COVID-19 to determine if initial infection confers long-term protective immunity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of clinical silent infection</measure>
    <time_frame>Screening-Month 36</time_frame>
    <description>Determine the incidence of clinically silent infection in household contacts</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Antibody and cell-mediated immune responses to SARS-CoV-2 over time</measure>
    <time_frame>Screening-Month 36</time_frame>
    <description>Characterize evolution of the antibody and T cell-mediated responses to SARS-CoV-2 in survivors over time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Antibody and cell-mediated immune responses to SARS-CoV-2</measure>
    <time_frame>Screening-Month 36</time_frame>
    <description>Characterize antibody and cell-mediated immune responses to SARS-CoV-2 in disease survivors</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">800</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Close Contacts</arm_group_label>
    <description>Individuals without COVID-19 diagnosis, lived in same home as a survivor during illness, were within 6 feet of a COVID-19 case for a prolonged period of time or had direct contact with secretions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COVID-19 Survivor</arm_group_label>
    <description>Individuals with documented prior COVID-19 infection and who have recovered</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Primary Clinical&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
        In order to be eligible to participate in this study, all individuals must meet all of the&#xD;
        following criteria:&#xD;
&#xD;
          1. Stated willingness to comply with all study procedures and availability for the&#xD;
             duration of the study&#xD;
&#xD;
          2. Age 18 years or older.&#xD;
&#xD;
          3. Ability of participant to understand and the willingness to sign a written informed&#xD;
             consent document.&#xD;
&#xD;
          4. Hemoglobin of 9.0 gm/dl or higher&#xD;
&#xD;
          5. Willingness to give consent for the storage of blood samples for research.&#xD;
&#xD;
          6. Have a physician or clinic outside NIH to manage underlying medical conditions or&#xD;
             agreeing to establish care with an outside physician or clinic for any medical&#xD;
             conditions requiring treatment that may be diagnosed as a result of protocol&#xD;
             participation.&#xD;
&#xD;
        COVID-19 Survivor Group&#xD;
&#xD;
          1. Documented prior COVID-19 as evidenced by:&#xD;
&#xD;
               1. detection of SARS-CoV-2 RNA or antigen in nasopharyngeal swab, sputum or other&#xD;
                  sample source with EUA/approval from the FDA; or&#xD;
&#xD;
               2. a positive antibody test using an assay that has received emergency use&#xD;
                  authorization (EUA) from the Food and Drug Administration (FDA) and a history&#xD;
                  clinical manifestation compatible with COVID-19.&#xD;
&#xD;
          2. Greater than 6 weeks since onset of COVID-19 symptoms and no fever for at least 1&#xD;
             week. For individuals with asymptomatic infection, screening will not occur until at&#xD;
             least 4 weeks after the last positive SARS-CoV-2 PCR or antigen test.&#xD;
&#xD;
        COVID-19 Close Contact&#xD;
&#xD;
          1. Living in the same household as a COVID-19 survivor during the time of illness or,&#xD;
             being within approximately 6 feet (2 meters) of a COVID-19 case for a prolonged period&#xD;
             of time or having direct contact with infectious secretions of a COVID-19 case (e.g.,&#xD;
             being coughed on).&#xD;
&#xD;
          2. No diagnosis of COVID-19 or current symptoms suggestive of COVID-19&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
        An individual who meets any of the following criteria will be excluded from participation&#xD;
        in this study:&#xD;
&#xD;
          1. Current abuse of alcohol or other drugs that, in the judgement of the Principal&#xD;
             Investigator (PI) could interfere with patient compliance.&#xD;
&#xD;
          2. Inability to travel to the NIH Clinical Center for study visits&#xD;
&#xD;
          3. Any medical or mental health condition that, in the judgement of the PI, would make&#xD;
             the volunteer unable to participate in the study.&#xD;
&#xD;
          4. Positive SARS-CoV-2 PCR at screening visit&#xD;
&#xD;
          5. Positive test for antibodies to SARS-CoV-2 nucleocapsid protein at the screening visit&#xD;
             (control group only).&#xD;
&#xD;
          6. History of any of the following in the past 14 days: fever &gt; 38.2 degrees Celsius; new&#xD;
             or worsening respiratory symptoms (e.g. cough, dyspnea).&#xD;
&#xD;
          7. Pregnancy&#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>Michael C Sneller, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Allergy and Infectious Diseases (NIAID)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bryan P Higgins, R.N.</last_name>
    <phone>(301) 761-7395</phone>
    <email>bryan.higgins@nih.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michael C Sneller, M.D.</last_name>
    <phone>(301) 496-0491</phone>
    <email>msneller@niaid.nih.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)</last_name>
      <phone>800-411-1222</phone>
      <phone_ext>TTY8664111010</phone_ext>
      <email>prpl@cc.nih.gov</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2020-I-0123.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <verification_date>September 5, 2023</verification_date>
  <study_first_submitted>May 30, 2020</study_first_submitted>
  <study_first_submitted_qc>May 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>September 6, 2023</last_update_submitted>
  <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronavirus</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>Medical Sequelae</keyword>
  <keyword>Antibody and Cell-mediated Immune Responses</keyword>
  <keyword>Protective Immunity</keyword>
  <keyword>Natural History</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>Undecided</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/NCT04411147
org study id: 200123
secondary id: 20-I-0123
nct id: NCT04411147
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background:

      COVID-19 is a disease caused by the SARS-CoV-2 virus. It infects the respiratory tract. Some
      people who get COVID-19 have only mild symptoms. But for others, infection leads to
      pneumonia, respiratory failure, and, in some cases, death. Researchers want to learn more
      about any effects that may persist after people recover from COVID-19.

      Objective:

      To learn about any long-term medical problems that people who have recovered from COVID-19
      might have, and whether they develop an immune response to SARS-CoV-2 that provides
      protection against reinfection.

      Eligibility:

      People age 18 and older who have recovered from documented COVID-19 or were in close contact
      with someone who had COVID-19 but did not get the infection

      Design:

      Participants will be screened over 2 visits. During visit 1, they will answer questions about
      any symptoms they are having and will be tested for SARS-CoV-2 infection which will involve a
      nasal swab sample or other FDA approved test. If the test is negative, they will proceed to
      the second visit, which will include:

      Physical examination

      Medical history

      Mental health interview (which may be recorded if the participant agrees)

      Chest x-ray (for recovered COVID-19 participants only)

      Blood and urine tests

      Pregnancy test (if needed)

      Lung function test (for recovered COVID-19 participants only)

      6-minute walk test (for recovered COVID-19 participants only)

      Questionnaires about their general and mental health

      Leukapheresis to collect white blood cells (optional).

      Participants will be put into 1 of 2 groups: the COVID-19 group or the close contact group.

      Participants will have study visits every 6 months for 3 years. They will repeat some of the
      screening tests. Participants in the COVID-19 group may have visits more often if they
      develop symptoms that suggest re-infection with SARS-CoV-2....
Study Description:

      This is a longitudinal cohort study to evaluate the clinical sequelae of acute COVID-19 and
      characterize the immune response to SARS-CoV-2. Household contacts of the COVID-19 cohort
      will also be recruited and serve as a control group.

      Objectives:

        -  Characterize the medical sequalae and persistent symptoms following recovery from
           COVID-19 in a cohort of disease survivors.

        -  Estimate the incidence and risk factors for post-COVID-19 medical sequalae.

        -  Characterize antibody and cell-mediated immune responses to SARS-CoV- 2 in disease
           survivors

        -  Characterize evolution of the antibody and T cell-mediated responses to SARS-CoV-2 in
           survivors over time

        -  Evaluate survivors for evidence of re-infection with future waves of COVID-19 to
           determine if initial infection confers long-term protective immunity

        -  Determine the incidence of clinically silent infection in household contacts

        -  Characterize the mental health status of survivors and controls including medical trauma
           related sequelae

      Endpoint:

      Establish a clinically well characterized cohort of persons recovered from COVID-19 and close
      contacts of persons with COVID-19
observational model: Cohort
time perspective: Prospective
measure: Risk Factors for Medical Sequelae in COVID-19 Survivors
time frame: Screening-Month 36
description: Estimate the incidence and risk factors for post-COVID-19 medical sequalae.
measure: Mental health status in COVID-19 survivors and contacts
time frame: Screening-Month 36
description: Characterize the mental health status of survivors and controls including medical trauma related sequelae
measure: Medical Sequelae in COVID-19 Survivors
time frame: Screening-Month 36
description: Characterize the medical sequelae and persistent symptoms following recovery from COVID-19 in a cohort of disease survivors.
measure: Incidence of reinfection with COVID-19
time frame: Screening-Month 36
description: Evaluate survivors for evidence of re-infection with future waves of COVID-19 to determine if initial infection confers long-term protective immunity
measure: Incidence of clinical silent infection
time frame: Screening-Month 36
description: Determine the incidence of clinically silent infection in household contacts
measure: Antibody and cell-mediated immune responses to SARS-CoV-2 over time
time frame: Screening-Month 36
description: Characterize evolution of the antibody and T cell-mediated responses to SARS-CoV-2 in survivors over time
measure: Antibody and cell-mediated immune responses to SARS-CoV-2
time frame: Screening-Month 36
description: Characterize antibody and cell-mediated immune responses to SARS-CoV-2 in disease survivors
arm group label: Close Contacts
description: Individuals without COVID-19 diagnosis, lived in same home as a survivor during illness, were within 6 feet of a COVID-19 case for a prolonged period of time or had direct contact with secretions
arm group label: COVID-19 Survivor
description: Individuals with documented prior COVID-19 infection and who have recovered
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: Michael C Sneller, M.D.
role: Principal Investigator
affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
last name: Bryan P Higgins, R.N.
phone: (301) 761-7395
email: bryan.higgins@nih.gov
last name: Michael C Sneller, M.D.
phone: (301) 496-0491
email: msneller@niaid.nih.gov
facility: 
status: Recruiting
contact: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2020-I-0123.html
description: NIH Clinical Center Detailed Web Page
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Undecided