<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/NCT04448145</url>
  </required_header>
  <id_info>
    <org_study_id>AAAS9722</org_study_id>
    <nct_id>NCT04448145</nct_id>
  </id_info>
  <brief_title>Determinants of SARS-COV2 (COVID-19) Persistence After Convalescence</brief_title>
  <acronym>C-PIC</acronym>
  <official_title>Characterizing SARS-CoV-2 Persistence in Host Reservoirs, Post-viral Sequelae, and Associations With Host and Viral Determinants in a Cohort of Convalescent COVID-19 Cases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia University</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 2019-2020 COVID-19 pandemic is the largest outbreak in recent history. It is not known&#xD;
      how long after someone gets sick with COVID-19 and recovers that they can still infect other&#xD;
      people. It is also not known how quickly people make antibodies against the virus, which help&#xD;
      clear infection from the body. The investigators will enroll 300 people who had COVID-19&#xD;
      based on lab testing or confirmed exposure to participate. An additional 25 participants who&#xD;
      have never tested positive for COVID and have not had the vaccine will be enrolled as&#xD;
      negative controls. Participants will complete a survey at enrollment. The investigators will&#xD;
      also collect blood, nose swab, saliva, stool, semen, and breast milk to test for the virus.&#xD;
      The investigators will ask participants to complete a survey and give specimens up to 12&#xD;
      times over 24 months. This information will be used to study how long the virus can live in&#xD;
      different parts of the body, antibody development, and post-infectious complications. The&#xD;
      investigators hope that this information will allow medical and public health providers to&#xD;
      make recommendations to better care for patients in the convalescent phase of COVID-19&#xD;
      infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an observational prospective cohort study of confirmed cases of COVID-19 recruited&#xD;
      from communities surrounding New York City. 325 participants will be recruited from&#xD;
      NewYork-Presbyterian (NYP)-Columbia hospital, the community using flyers and snowball&#xD;
      sampling, and by contacting participants who are already participating in a Columbia&#xD;
      University Irving Medical Center (CUIMC) COVID-19 related study and have given consent to be&#xD;
      contacted about participation in related research studies. Candidates will be eligible to&#xD;
      participate if they have received a laboratory confirmed diagnosis of COVID-19 or were&#xD;
      symptomatic and had a known contact with a confirmed case of COVID-19, and are over the age&#xD;
      of 7. Participants who were diagnosed empirically due to symptoms and exposure yet test&#xD;
      negative by Reverse transcription polymerase chain reaction (RT-PCR) and serology at baseline&#xD;
      will not be considered infected with SARS-CoV-2 and may be excluded. Participants will be&#xD;
      consented prior to participation in any study activities and will be prospectively followed&#xD;
      for 96 weeks. At baseline, an enrollment survey will be administered that includes&#xD;
      demographics, comorbidities, and characteristics of their COVID-19 illness (e.g., exposure,&#xD;
      symptom onset, symptom duration, severity of symptoms) and will provide blood and host&#xD;
      reservoir site samples. Participants will be followed for a 24 month period after symptom&#xD;
      onset, with a maximum of 12 visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 26, 2020</start_date>
  <completion_date type="Anticipated">May 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2024</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>Duration of SARS-CoV-2 viral persistence in naso/oropharyngeal samples</measure>
    <time_frame>Up to 96 weeks</time_frame>
    <description>Duration of SARS-CoV-2 viral persistence defined as the number of days from symptom onset to the most recent positive SARS-CoV-2 PCR naso/oropharyngeal test, as determined by the established cycle threshold cut-off on a validated real-time quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of SARS-CoV-2 viral persistence in stool or rectal swab samples</measure>
    <time_frame>Up to 96 weeks</time_frame>
    <description>Duration of SARS-CoV-2 viral persistence defined as the number of days from symptom onset to the most recent positive SARS-CoV-2 PCR stool or rectal swab samples, as determined by the established cycle threshold cut-off on a validated qRT-PCR assay.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of SARS-CoV-2 viral persistence in semen samples</measure>
    <time_frame>Up to 96 weeks</time_frame>
    <description>Duration of SARS-CoV-2 viral persistence defined as the number of days from symptom onset to the most recent positive SARS-CoV-2 PCR semen sample, as determined by the established cycle threshold cut-off on a validated qRT-PCR assay.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of SARS-CoV-2 viral persistence in breast milk samples</measure>
    <time_frame>Up to 96 weeks</time_frame>
    <description>Duration of SARS-CoV-2 viral persistence defined as the number of days from symptom onset to the most recent positive SARS-CoV-2 PCR breast milk sample, as determined by the established cycle threshold cut-off on a validated qRT-PCR assay.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of cell immune responses</measure>
    <time_frame>Up to 96 Weeks</time_frame>
    <description>Prevalence defined as the number of participants with B cell, cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8), natural killer (NK), and natural killer T (NKT) cell immune responses. Plasma will be used for evaluation of neutralizing and binding antibody titers to SARS-CoV-2.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of COVID-19 Symptoms</measure>
    <time_frame>Up to 96 weeks</time_frame>
    <description>The duration, in weeks, of COVID-19 symptoms as assessed by a symptom survey. Participants will complete health surveys at each study visit that include questions regarding COVID-19 symptoms, in addition to general health questions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of post-viral sequelae</measure>
    <time_frame>Up to 96 weeks</time_frame>
    <description>Prevalence defined as the number of participants that develop post-viral sequelae as assessed by a symptom survey. Participants will complete health surveys at each study visit that include questions regarding COVID-19 symptoms, in addition to general health questions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of SARS-CoV-2 persistence and bacterial/viral community structures</measure>
    <time_frame>Up to 96 weeks</time_frame>
    <description>Prevalence defined as the number of participants with SARS-CoV-2 persistence and bacterial/viral community structures.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">325</enrollment>
  <condition>COVID-19</condition>
  <condition>Corona Virus Infection</condition>
  <condition>SARS-CoV 2</condition>
  <arm_group>
    <arm_group_label>COVID-19 Positive</arm_group_label>
    <description>Participants who have been diagnosed with COVID-19 or experienced symptoms of COVID-19.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COVID-19 Negative</arm_group_label>
    <description>Participants who have never tested positive for COVID-19.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Saliva, Nasal Swab, Blood, Stool, Semen, Breastmilk&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All participants with RT-PCR positive for SARS-CoV-2 or diagnosed empirically based on&#xD;
        known exposure and symptoms of fever, cough, and shortness of breath. Empirically diagnosed&#xD;
        individuals who are negative at baseline by RT-PCR and serology Immunoglobulin M&#xD;
        (IgM)/Immunoglobulin G (IgG) will be classified as uninfected and will not participate&#xD;
        further, but may be replaced. Negative participants with no known prior COVID-19 diagnosis&#xD;
        or COVID-19 vaccine.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Laboratory confirmed SARS-CoV-2 using currently available laboratory testing&#xD;
             techniques (e.g.,RT-PCR, Immunoglobulin M (IgM) /IgG) or clinical history compatible&#xD;
             with a COVID-19 like illness(fever, cough, shortness of breath).&#xD;
&#xD;
          -  Negative participants with no known prior COVID-19 diagnosis or COVID vaccine&#xD;
&#xD;
          -  At least 7 years of age&#xD;
&#xD;
          -  Participants are eligible to provide semen and breast milk samples if they are 18&#xD;
             years of age or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;7&#xD;
&#xD;
          -  Intercurrent conditions that in the opinion of the investigator would confound the&#xD;
             findings of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Yin, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate Professor of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michael Yin, MD, MS</last_name>
    <phone>212-305-7185</phone>
    <email>mty4@cumc.columbia.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lawrence Purpura, MD, MPH</last_name>
    <phone>212-305-2220</phone>
    <email>lp2745@cumc.columbia.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Michael Yin, MD, MS</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lawrence Purpura, MD, MPH</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://recruit.cumc.columbia.edu/clinical_trial/1940</url>
    <description>Columbia University Study Link and Eligibility Questionnaire</description>
  </link>
  <reference>
    <citation>Bergantz L, Subra F, Deprez E, Delelis O, Richetta C. Interplay between Intrinsic and Innate Immunity during HIV Infection. Cells. 2019 Aug 17;8(8):922. doi: 10.3390/cells8080922.</citation>
    <PMID>31426525</PMID>
  </reference>
  <reference>
    <citation>2. New York State Department of Health. https://coronavirus.health.ny.gov/countycounty-breakdown-positive-cases. Accessed March 23, 2020</citation>
  </reference>
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    <citation>3. WHO Coronavirus disease 2019, Situation Report-63</citation>
  </reference>
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    <citation>4. Discontinuation of Transmission-Based Precautions and Disposition of Patients with COVID-19 in Healthcare Settings (Interim Guidance). https://www.cdc.gov/coronavirus/2019-ncov/hcp/disposition-hospitalized-patients.html. Accessed March 23, 2020.</citation>
  </reference>
  <reference>
    <citation>Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum In: JAMA. 2021 Mar 16;325(11):1113.</citation>
    <PMID>32031570</PMID>
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    <citation>Holshue ML, DeBolt C, Lindquist S, Lofy KH, Wiesman J, Bruce H, Spitters C, Ericson K, Wilkerson S, Tural A, Diaz G, Cohn A, Fox L, Patel A, Gerber SI, Kim L, Tong S, Lu X, Lindstrom S, Pallansch MA, Weldon WC, Biggs HM, Uyeki TM, Pillai SK; Washington State 2019-nCoV Case Investigation Team. First Case of 2019 Novel Coronavirus in the United States. N Engl J Med. 2020 Mar 5;382(10):929-936. doi: 10.1056/NEJMoa2001191. Epub 2020 Jan 31.</citation>
    <PMID>32004427</PMID>
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    <citation>Severe acute respiratory syndrome (SARS). Wkly Epidemiol Rec. 2003 Mar 21;78(12):81-3. No abstract available. English, French.</citation>
    <PMID>12701272</PMID>
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    <citation>Chan KH, Poon LL, Cheng VC, Guan Y, Hung IF, Kong J, Yam LY, Seto WH, Yuen KY, Peiris JS. Detection of SARS coronavirus in patients with suspected SARS. Emerg Infect Dis. 2004 Feb;10(2):294-9. doi: 10.3201/eid1002.030610.</citation>
    <PMID>15030700</PMID>
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    <citation>Corman VM, Albarrak AM, Omrani AS, Albarrak MM, Farah ME, Almasri M, Muth D, Sieberg A, Meyer B, Assiri AM, Binger T, Steinhagen K, Lattwein E, Al-Tawfiq J, Muller MA, Drosten C, Memish ZA. Viral Shedding and Antibody Response in 37 Patients With Middle East Respiratory Syndrome Coronavirus Infection. Clin Infect Dis. 2016 Feb 15;62(4):477-483. doi: 10.1093/cid/civ951. Epub 2015 Nov 12.</citation>
    <PMID>26565003</PMID>
  </reference>
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    <citation>Haak BW, Littmann ER, Chaubard JL, Pickard AJ, Fontana E, Adhi F, Gyaltshen Y, Ling L, Morjaria SM, Peled JU, van den Brink MR, Geyer AI, Cross JR, Pamer EG, Taur Y. Impact of gut colonization with butyrate-producing microbiota on respiratory viral infection following allo-HCT. Blood. 2018 Jun 28;131(26):2978-2986. doi: 10.1182/blood-2018-01-828996. Epub 2018 Apr 19.</citation>
    <PMID>29674425</PMID>
  </reference>
  <reference>
    <citation>PREVAIL III Study Group; Sneller MC, Reilly C, Badio M, Bishop RJ, Eghrari AO, Moses SJ, Johnson KL, Gayedyu-Dennis D, Hensley LE, Higgs ES, Nath A, Tuznik K, Varughese J, Jensen KS, Dighero-Kemp B, Neaton JD, Lane HC, Fallah MP. A Longitudinal Study of Ebola Sequelae in Liberia. N Engl J Med. 2019 Mar 7;380(10):924-934. doi: 10.1056/NEJMoa1805435.</citation>
    <PMID>30855742</PMID>
  </reference>
  <reference>
    <citation>Kurscheidt FA, Mesquita CSS, Damke GMZF, Damke E, Carvalho ARBA, Suehiro TT, Teixeira JJV, da Silva VRS, Souza RP, Consolaro MEL. Persistence and clinical relevance of Zika virus in the male genital tract. Nat Rev Urol. 2019 Apr;16(4):211-230. doi: 10.1038/s41585-019-0149-7.</citation>
    <PMID>30696994</PMID>
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    <citation>Den Boon S, Marston BJ, Nyenswah TG, Jambai A, Barry M, Keita S, Durski K, Senesie SS, Perkins D, Shah A, Green HH, Hamblion EL, Lamunu M, Gasasira A, Mahmoud NO, Djingarey MH, Morgan O, Crozier I, Dye C. Ebola Virus Infection Associated with Transmission from Survivors. Emerg Infect Dis. 2019 Feb;25(2):249-255. doi: 10.3201/eid2502.181011. Epub 2019 Feb 17.</citation>
    <PMID>30500321</PMID>
  </reference>
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    <citation>Jacobs M, Rodger A, Bell DJ, Bhagani S, Cropley I, Filipe A, Gifford RJ, Hopkins S, Hughes J, Jabeen F, Johannessen I, Karageorgopoulos D, Lackenby A, Lester R, Liu RS, MacConnachie A, Mahungu T, Martin D, Marshall N, Mepham S, Orton R, Palmarini M, Patel M, Perry C, Peters SE, Porter D, Ritchie D, Ritchie ND, Seaton RA, Sreenu VB, Templeton K, Warren S, Wilkie GS, Zambon M, Gopal R, Thomson EC. Late Ebola virus relapse causing meningoencephalitis: a case report. Lancet. 2016 Jul 30;388(10043):498-503. doi: 10.1016/S0140-6736(16)30386-5. Epub 2016 May 18.</citation>
    <PMID>27209148</PMID>
  </reference>
  <reference>
    <citation>Soka MJ, Choi MJ, Baller A, White S, Rogers E, Purpura LJ, Mahmoud N, Wasunna C, Massaquoi M, Abad N, Kollie J, Dweh S, Bemah PK, Christie A, Ladele V, Subah OC, Pillai S, Mugisha M, Kpaka J, Kowalewski S, German E, Stenger M, Nichol S, Stroher U, Vanderende KE, Zarecki SM, Green HH, Bailey JA, Rollin P, Marston B, Nyenswah TG, Gasasira A, Knust B, Williams D. Prevention of sexual transmission of Ebola in Liberia through a national semen testing and counselling programme for survivors: an analysis of Ebola virus RNA results and behavioural data. Lancet Glob Health. 2016 Oct;4(10):e736-43. doi: 10.1016/S2214-109X(16)30175-9. Epub 2016 Aug 30. Erratum In: Lancet Glob Health. 2016 Nov;4(11):e793.</citation>
    <PMID>27596037</PMID>
  </reference>
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    <citation>van Doremalen N, Bushmaker T, Morris DH, Holbrook MG, Gamble A, Williamson BN, Tamin A, Harcourt JL, Thornburg NJ, Gerber SI, Lloyd-Smith JO, de Wit E, Munster VJ. Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1. N Engl J Med. 2020 Apr 16;382(16):1564-1567. doi: 10.1056/NEJMc2004973. Epub 2020 Mar 17. No abstract available.</citation>
    <PMID>32182409</PMID>
  </reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>July 19, 2022</last_update_submitted>
  <last_update_submitted_qc>July 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Novel Coronavirus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>De-identified patient data, including test results, may be shared with other researchers within Columbia University at the discretion of the Principal Investigator, and only when the Institutional Review Board (IRB) approval has been granted to allow for the sharing of such data.</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/NCT04448145
org study id: AAAS9722
nct id: NCT04448145
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The 2019-2020 COVID-19 pandemic is the largest outbreak in recent history. It is not known
      how long after someone gets sick with COVID-19 and recovers that they can still infect other
      people. It is also not known how quickly people make antibodies against the virus, which help
      clear infection from the body. The investigators will enroll 300 people who had COVID-19
      based on lab testing or confirmed exposure to participate. An additional 25 participants who
      have never tested positive for COVID and have not had the vaccine will be enrolled as
      negative controls. Participants will complete a survey at enrollment. The investigators will
      also collect blood, nose swab, saliva, stool, semen, and breast milk to test for the virus.
      The investigators will ask participants to complete a survey and give specimens up to 12
      times over 24 months. This information will be used to study how long the virus can live in
      different parts of the body, antibody development, and post-infectious complications. The
      investigators hope that this information will allow medical and public health providers to
      make recommendations to better care for patients in the convalescent phase of COVID-19
      infection.
This is an observational prospective cohort study of confirmed cases of COVID-19 recruited
      from communities surrounding New York City. 325 participants will be recruited from
      NewYork-Presbyterian (NYP)-Columbia hospital, the community using flyers and snowball
      sampling, and by contacting participants who are already participating in a Columbia
      University Irving Medical Center (CUIMC) COVID-19 related study and have given consent to be
      contacted about participation in related research studies. Candidates will be eligible to
      participate if they have received a laboratory confirmed diagnosis of COVID-19 or were
      symptomatic and had a known contact with a confirmed case of COVID-19, and are over the age
      of 7. Participants who were diagnosed empirically due to symptoms and exposure yet test
      negative by Reverse transcription polymerase chain reaction (RT-PCR) and serology at baseline
      will not be considered infected with SARS-CoV-2 and may be excluded. Participants will be
      consented prior to participation in any study activities and will be prospectively followed
      for 96 weeks. At baseline, an enrollment survey will be administered that includes
      demographics, comorbidities, and characteristics of their COVID-19 illness (e.g., exposure,
      symptom onset, symptom duration, severity of symptoms) and will provide blood and host
      reservoir site samples. Participants will be followed for a 24 month period after symptom
      onset, with a maximum of 12 visits.
observational model: Cohort
time perspective: Prospective
measure: Duration of SARS-CoV-2 viral persistence in naso/oropharyngeal samples
time frame: Up to 96 weeks
description: Duration of SARS-CoV-2 viral persistence defined as the number of days from symptom onset to the most recent positive SARS-CoV-2 PCR naso/oropharyngeal test, as determined by the established cycle threshold cut-off on a validated real-time quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay.
measure: Duration of SARS-CoV-2 viral persistence in stool or rectal swab samples
time frame: Up to 96 weeks
description: Duration of SARS-CoV-2 viral persistence defined as the number of days from symptom onset to the most recent positive SARS-CoV-2 PCR stool or rectal swab samples, as determined by the established cycle threshold cut-off on a validated qRT-PCR assay.
measure: Duration of SARS-CoV-2 viral persistence in semen samples
time frame: Up to 96 weeks
description: Duration of SARS-CoV-2 viral persistence defined as the number of days from symptom onset to the most recent positive SARS-CoV-2 PCR semen sample, as determined by the established cycle threshold cut-off on a validated qRT-PCR assay.
measure: Duration of SARS-CoV-2 viral persistence in breast milk samples
time frame: Up to 96 weeks
description: Duration of SARS-CoV-2 viral persistence defined as the number of days from symptom onset to the most recent positive SARS-CoV-2 PCR breast milk sample, as determined by the established cycle threshold cut-off on a validated qRT-PCR assay.
measure: Prevalence of cell immune responses
time frame: Up to 96 Weeks
description: Prevalence defined as the number of participants with B cell, cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8), natural killer (NK), and natural killer T (NKT) cell immune responses. Plasma will be used for evaluation of neutralizing and binding antibody titers to SARS-CoV-2.
measure: Duration of COVID-19 Symptoms
time frame: Up to 96 weeks
description: The duration, in weeks, of COVID-19 symptoms as assessed by a symptom survey. Participants will complete health surveys at each study visit that include questions regarding COVID-19 symptoms, in addition to general health questions.
measure: Prevalence of post-viral sequelae
time frame: Up to 96 weeks
description: Prevalence defined as the number of participants that develop post-viral sequelae as assessed by a symptom survey. Participants will complete health surveys at each study visit that include questions regarding COVID-19 symptoms, in addition to general health questions.
measure: Prevalence of SARS-CoV-2 persistence and bacterial/viral community structures
time frame: Up to 96 weeks
description: Prevalence defined as the number of participants with SARS-CoV-2 persistence and bacterial/viral community structures.
arm group label: COVID-19 Positive
description: Participants who have been diagnosed with COVID-19 or experienced symptoms of COVID-19.
arm group label: COVID-19 Negative
description: Participants who have never tested positive for COVID-19.
Saliva, Nasal Swab, Blood, Stool, Semen, Breastmilk
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Yin, MD, MS
role: Principal Investigator
affiliation: Associate Professor of Medicine
last name: Michael Yin, MD, MS
phone: 212-305-7185
email: mty4@cumc.columbia.edu
last name: Lawrence Purpura, MD, MPH
phone: 212-305-2220
email: lp2745@cumc.columbia.edu
facility: 
status: Recruiting
investigator: 
investigator: 
country: United States
url: https://recruit.cumc.columbia.edu/clinical_trial/1940
description: Columbia University Study Link and Eligibility Questionnaire
citation: Bergantz L, Subra F, Deprez E, Delelis O, Richetta C. Interplay between Intrinsic and Innate Immunity during HIV Infection. Cells. 2019 Aug 17;8(8):922. doi: 10.3390/cells8080922.
PMID: 31426525
citation: 2. New York State Department of Health. https://coronavirus.health.ny.gov/countycounty-breakdown-positive-cases. Accessed March 23, 2020
citation: 3. WHO Coronavirus disease 2019, Situation Report-63
citation: 4. Discontinuation of Transmission-Based Precautions and Disposition of Patients with COVID-19 in Healthcare Settings (Interim Guidance). https://www.cdc.gov/coronavirus/2019-ncov/hcp/disposition-hospitalized-patients.html. Accessed March 23, 2020.
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responsible party type: Sponsor
mesh term: COVID-19
mesh term: Coronavirus Infections
sharing ipd: Undecided
ipd description: De-identified patient data, including test results, may be shared with other researchers within Columbia University at the discretion of the Principal Investigator, and only when the Institutional Review Board (IRB) approval has been granted to allow for the sharing of such data.