<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/NCT04470999</url>
  </required_header>
  <id_info>
    <org_study_id>SRPH-CVD-01</org_study_id>
    <nct_id>NCT04470999</nct_id>
  </id_info>
  <brief_title>Changes in Cellular Immune Profile During COVID-19 Infection</brief_title>
  <official_title>Cellular Immune Profile Changes in Individuals With Active or Past COVID-19 Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Serhat Gumrukcu, MD PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Scripps Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seraph Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Clinical specimens are collected from individuals either recovered from or with active&#xD;
      SARS-CoV-2 infection to support process and analytical development for a potential cell-based&#xD;
      immunotherapy in preclinical research, SRPH-CVD-01.&#xD;
&#xD;
      SRPH-CVD-01 is an allogeneic cell-based immunotherapy candidate to be investigated in a&#xD;
      subsequent clinical trial under a future FDA IND to treat people suffering from COVID-19.&#xD;
&#xD;
      Enrolled participants provide a venous blood specimen (up to 40mL) to be used in preclinical&#xD;
      studies and research and development of SRPH-CVD-01. Subjects may eventually be asked to&#xD;
      undergo leukapheresis for peripheral blood mononuclear cell (PBMC) collection and their&#xD;
      specimens will be used to further develop the SRPH-CVD-01 cell product, including a cGMP&#xD;
      compliant process to be applied under the future FDA IND.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This protocol is to collect blood and PBMC specimens from individuals with active of past&#xD;
      COVID-19 infection. The first blood draw will be done at the first study visit and if&#xD;
      eligible, the second collection will be done via leukapheresis at the second visit. The&#xD;
      leukapheresis procedures will follow the facility's standard operating procedures and&#xD;
      protocol requirements for leukapheresis.&#xD;
&#xD;
      Donors will be males or females between and including the ages of 18 years and 60 years.&#xD;
      Volunteers will provide written informed consent and meet all inclusion and exclusion&#xD;
      criteria. Each participant can be in the study for up to 180 days (6 months).&#xD;
&#xD;
      The study will be conducted in accordance with human research for the purposes of obtaining&#xD;
      clinical specimens for research. There is no endpoint for this study, however, data collected&#xD;
      from this study will include, but not be limited to, gender, demographics, medical history,&#xD;
      clinical laboratory values, and volume of the blood collected. The data will be summarized in&#xD;
      future studies reporting results from a future clinical trial under FDA IND.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Study suspended due to the move of clinical trial site. It will be resumed when the move is&#xD;
    complete.&#xD;
  </why_stopped>
  <start_date type="Actual">April 15, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cellular immune system profiling</measure>
    <time_frame>Up to 20 days</time_frame>
    <description>After the initial venous blood draw, the blood samples will be tested to measure the absolute count and percentage of B cells, monocytes, CD4+ and CD8+ T cells, gammadelta T (gdT) cells, CD3+CD56+ natural killer T (NKT) cells, and natural killer (NK) cells in total PBMCs.&#xD;
Data will describe the range of each cell population across participants.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Innate immune system profiling</measure>
    <time_frame>Up to 100 days</time_frame>
    <description>Innate immune system cells (gdT, NKT, and NK) will be assessed for their SARS-CoV-2 antiviral activity by stimulation and immunophenotyping.&#xD;
Data will report the antiviral phenotypic characteristics of these cells.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expansion of virus-specific innate immune cells</measure>
    <time_frame>Up to 100 days</time_frame>
    <description>Virus-specific innate immune cells that are relevant to SRPH-CVD-01 clinical product candidate will be expanded under various conditions to assess their therapeutic and protective potential against COVID-19. Data will report the expansion rate of SRPH-CVD-01 cells.&#xD;
These cell will also help validate the assays and processes for the development of the SRPH-CVD-01 cell product to be used in a future clinical trials.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Covid19</condition>
  <condition>SARS-CoV-2</condition>
  <arm_group>
    <arm_group_label>Single arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Venous blood and apheresis collection will be conducted</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Leukapheresis</intervention_name>
    <description>Blood collection and PBMC collection via apheresis machine will be conducted</description>
    <arm_group_label>Single arm</arm_group_label>
    <other_name>Mononuclear cell collection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male of female aged 18-60&#xD;
&#xD;
          -  Documented current or past (max 3 months prior) diagnosis of COVID19&#xD;
&#xD;
          -  Participants who has not participated in a cell or gene therapy trial for COVID19&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled SARS symptoms&#xD;
&#xD;
          -  Oxygen saturation (Pulse Ox) &lt; 90%&#xD;
&#xD;
          -  Uncontrolled diabetes&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Active DIC, bleeding or coagulopathy which cannot be corrected with minimal&#xD;
             intervention&#xD;
&#xD;
          -  Symptomatic, uncontrolled or severe intercurrent illness that would compromise the&#xD;
             ability to tolerate blood collection or leukapheresis procedure&#xD;
&#xD;
          -  Systemic chemotherapy less than or equal to 2 weeks (6 weeks for clofarabine or&#xD;
             nitrosoureas) or radiation therapy less than or equal to 3 weeks prior to&#xD;
             leukapheresis&#xD;
&#xD;
          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a&#xD;
             female after conception and until the termination of gestation, confirmed by a&#xD;
             positive hCG laboratory test at screening&#xD;
&#xD;
          -  Any patient that in the opinion of the investigator is not medically stable to undergo&#xD;
             the leukapheresis procedure or will not comply with the visit schedules or procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Serhat Gumrukcu, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seraph Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seraph Research Institute</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>May 17, 2022</last_update_submitted>
  <last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Seraph Research Institute</investigator_affiliation>
    <investigator_full_name>Serhat Gumrukcu, MD PhD</investigator_full_name>
    <investigator_title>Sponsor-Investigator</investigator_title>
  </responsible_party>
  <keyword>SARS-CoV-2</keyword>
  <keyword>COVID</keyword>
  <keyword>COVID19</keyword>
  <keyword>Coronavirus</keyword>
  <keyword>Cell therapy</keyword>
  <keyword>Immunotherapy</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>No</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/NCT04470999
org study id: SRPH-CVD-01
nct id: NCT04470999
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Clinical specimens are collected from individuals either recovered from or with active
      SARS-CoV-2 infection to support process and analytical development for a potential cell-based
      immunotherapy in preclinical research, SRPH-CVD-01.

      SRPH-CVD-01 is an allogeneic cell-based immunotherapy candidate to be investigated in a
      subsequent clinical trial under a future FDA IND to treat people suffering from COVID-19.

      Enrolled participants provide a venous blood specimen (up to 40mL) to be used in preclinical
      studies and research and development of SRPH-CVD-01. Subjects may eventually be asked to
      undergo leukapheresis for peripheral blood mononuclear cell (PBMC) collection and their
      specimens will be used to further develop the SRPH-CVD-01 cell product, including a cGMP
      compliant process to be applied under the future FDA IND.
This protocol is to collect blood and PBMC specimens from individuals with active of past
      COVID-19 infection. The first blood draw will be done at the first study visit and if
      eligible, the second collection will be done via leukapheresis at the second visit. The
      leukapheresis procedures will follow the facility's standard operating procedures and
      protocol requirements for leukapheresis.

      Donors will be males or females between and including the ages of 18 years and 60 years.
      Volunteers will provide written informed consent and meet all inclusion and exclusion
      criteria. Each participant can be in the study for up to 180 days (6 months).

      The study will be conducted in accordance with human research for the purposes of obtaining
      clinical specimens for research. There is no endpoint for this study, however, data collected
      from this study will include, but not be limited to, gender, demographics, medical history,
      clinical laboratory values, and volume of the blood collected. The data will be summarized in
      future studies reporting results from a future clinical trial under FDA IND.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Cellular immune system profiling
time frame: Up to 20 days
description: After the initial venous blood draw, the blood samples will be tested to measure the absolute count and percentage of B cells, monocytes, CD4+ and CD8+ T cells, gammadelta T (gdT) cells, CD3+CD56+ natural killer T (NKT) cells, and natural killer (NK) cells in total PBMCs.
Data will describe the range of each cell population across participants.
measure: Innate immune system profiling
time frame: Up to 100 days
description: Innate immune system cells (gdT, NKT, and NK) will be assessed for their SARS-CoV-2 antiviral activity by stimulation and immunophenotyping.
Data will report the antiviral phenotypic characteristics of these cells.
measure: Expansion of virus-specific innate immune cells
time frame: Up to 100 days
description: Virus-specific innate immune cells that are relevant to SRPH-CVD-01 clinical product candidate will be expanded under various conditions to assess their therapeutic and protective potential against COVID-19. Data will report the expansion rate of SRPH-CVD-01 cells.
These cell will also help validate the assays and processes for the development of the SRPH-CVD-01 cell product to be used in a future clinical trials.
arm group label: Single arm
arm group type: Experimental
description: Venous blood and apheresis collection will be conducted
intervention type: Other
intervention name: Leukapheresis
description: Blood collection and PBMC collection via apheresis machine will be conducted
arm group label: Single arm
other name: Mononuclear cell collection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Serhat Gumrukcu, MD PhD
role: Principal Investigator
affiliation: Seraph Research Institute
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Seraph Research Institute
investigator full name: Serhat Gumrukcu, MD PhD
investigator title: Sponsor-Investigator
mesh term: COVID-19
sharing ipd: No