<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/NCT04501796</url>
  </required_header>
  <id_info>
    <org_study_id>NIT-116 (SPESELPIS)</org_study_id>
    <nct_id>NCT04501796</nct_id>
  </id_info>
  <brief_title>A Trial of NT-I7 in COVID-19 (SPESELPIS)</brief_title>
  <official_title>A Double-blind, Randomized, Placebo-controlled, Phase 1, Single-dose, Dose-escalating Trial of Long-acting Recombinant Human IL-7 (NT-I7) for COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NeoImmuneTech</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Nebraska</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NeoImmuneTech</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purposes of this study is to determine the following in participants with mild&#xD;
      coronavirus disease 2019 (COVID-19):&#xD;
&#xD;
        -  Safety of a single dose of NT-I7&#xD;
&#xD;
        -  The immunological effects of NT-I7 on peripheral lymphocyte counts in COVID-19 patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multisite, double-blind, randomized, placebo-controlled, dose-escalating, phase 1&#xD;
      trial of NT-I7 with standard of care (SOC) versus placebo with SOC to evaluate the safety and&#xD;
      efficacy of NT-I7 in adults with mild coronavirus disease 2019 (COVID-19). After&#xD;
      determination of eligibility and baseline assessment, a single dose of the study agent (NT-I7&#xD;
      or placebo) will be administered after 1:1 randomization, along with SOC. Research blood&#xD;
      collection will occur at baseline, days 3, 7, 14, 30, 60 and 90 days after administration.&#xD;
      Primary and secondary evaluations will include assessment of adverse events (AEs), absolute&#xD;
      lymphocyte count (ALC), and trajectory of other lymphocytes subsets: CD4, CD8, natural killer&#xD;
      (NK), B, and mucosal-associated-invariant T (MAIT) cells. The final study visit will be at&#xD;
      day 90 after the study agent administration. The investigators hypothesize that NT-I7 is safe&#xD;
      for administration and preserves lymphocyte homeostasis in patients with mild COVID-19.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study was halted due to lack of patient population resulting in slow enrollment.&#xD;
  </why_stopped>
  <start_date type="Actual">November 27, 2020</start_date>
  <completion_date type="Actual">February 23, 2023</completion_date>
  <primary_completion_date type="Actual">July 21, 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double-Blind.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the safety of a single dose of NT-I7 in a dose escalation fashion</measure>
    <time_frame>Up to approximately 30 days</time_frame>
    <description>Assessment of the number and severity of AEs possibly, probably, or definitely related to study drug evaluated at 7 and 30 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the immunological effects of NT-I7 cumulatively for all doses on peripheral lymphocyte counts in COVID-19 patients.</measure>
    <time_frame>Up to approximately 30 days</time_frame>
    <description>Assessment of the trajectory of ALC, CD4, CD8, NK, B, and MAIT cells measured at days 7, 14 and 30 after administration of NT-I7 or placebo compared to baseline values.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>NT-I7</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NT-I7 will be administered once by IM injection within 24 hours of baseline (day 0). The treatment course pursued in all enrolled participants will be a single dose. Dosing will be staggered with at least 72 hours between each study participant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo will be administered once by IM injection within 24 hours of baseline (day 0). The treatment course pursued in all enrolled participants will be a single dose. Dosing will be staggered with at least 72 hours between each study participant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Double-Blind NT-I7</intervention_name>
    <description>Administered by intramuscular (IM) injection</description>
    <arm_group_label>NT-I7</arm_group_label>
    <other_name>rhIL-7-hyFc</other_name>
    <other_name>efineptakin alfa</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Double-Blind Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals must meet all of the following criteria to be included in the study:&#xD;
&#xD;
          -  Laboratory-confirmed SARS-CoV-2 infection as determined by either a documented&#xD;
             positive molecular assay/ other commercial or public health assay in any specimen&#xD;
             collected &lt; 5 days prior to screening or a documented positive molecular assay ≥ 5&#xD;
             days prior to screening and confirmed by polymerase chain reaction (PCR) at screening.&#xD;
&#xD;
          -  Illness of any duration with oxygen saturation &gt; 93% at room air, heart rate ≤ 100&#xD;
             beats per minute at rest, and no evidence of respiratory distress with respiration&#xD;
             rate &lt; 20 breaths per minute.&#xD;
&#xD;
          -  Able to provide informed consent.&#xD;
&#xD;
          -  Aged ≥ 19 and ≤ 75 years.&#xD;
&#xD;
          -  Absolute Lymphocyte Count &lt;1,500 lymphocytes/µL.&#xD;
&#xD;
          -  Avoid becoming pregnant or impregnate a partner through 90 days after study agent&#xD;
             administration. Females must agree to 2 methods of contraception, and males to at&#xD;
             least one method of contraception.&#xD;
&#xD;
          -  Not participate in any other clinical trial for an investigational therapy through day&#xD;
             30.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Moderate to severe hypoxic respiratory failure requiring supplemental oxygen at rest,&#xD;
             mechanical ventilation, ECMO, or any other noninvasive ventilation modality.&#xD;
&#xD;
          -  CRP &gt;15 mg/L or D-dimer &gt; 0.75 µg/mL.&#xD;
&#xD;
          -  Estimated glomerular filtration rate (eGFR) &lt; 40 mL/min/1.73m2, or requiring dialysis.&#xD;
&#xD;
          -  AST/ALT &gt; 3-times ULN, or total bilirubin &gt; 1.5 times ULN (except if due to Gilbert's&#xD;
             syndrome).&#xD;
&#xD;
          -  Pregnancy or breastfeeding.&#xD;
&#xD;
          -  Use of systemic corticosteroids or immunomodulant within 4 weeks prior to screening.&#xD;
&#xD;
          -  Receipt of an investigational agent or investigational use of a licensed agent within&#xD;
             16 weeks prior to screening.&#xD;
&#xD;
          -  HIV infection or underlying history of known or unknown primary or acquired&#xD;
             immunodeficiency associated with lymphopenia and/or recurrent opportunistic&#xD;
             infections.&#xD;
&#xD;
          -  Autoimmune disease requiring systemic treatment EXCEPT for vitiligo or endocrine&#xD;
             disease (such as diabetes, thyroid disease, and adrenal disease) controlled by&#xD;
             replacement therapy.&#xD;
&#xD;
          -  Malignancy requiring treatment 1 year prior to screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nih/Niaid</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>July 13, 2023</last_update_submitted>
  <last_update_submitted_qc>July 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NT-I7 (efineptakin alfa, rhIL-7-hyFc)</keyword>
  <keyword>COVID-19</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/NCT04501796
org study id: NIT-116 (SPESELPIS)
nct id: NCT04501796
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The main purposes of this study is to determine the following in participants with mild
      coronavirus disease 2019 (COVID-19):

        -  Safety of a single dose of NT-I7

        -  The immunological effects of NT-I7 on peripheral lymphocyte counts in COVID-19 patients.
This is a multisite, double-blind, randomized, placebo-controlled, dose-escalating, phase 1
      trial of NT-I7 with standard of care (SOC) versus placebo with SOC to evaluate the safety and
      efficacy of NT-I7 in adults with mild coronavirus disease 2019 (COVID-19). After
      determination of eligibility and baseline assessment, a single dose of the study agent (NT-I7
      or placebo) will be administered after 1:1 randomization, along with SOC. Research blood
      collection will occur at baseline, days 3, 7, 14, 30, 60 and 90 days after administration.
      Primary and secondary evaluations will include assessment of adverse events (AEs), absolute
      lymphocyte count (ALC), and trajectory of other lymphocytes subsets: CD4, CD8, natural killer
      (NK), B, and mucosal-associated-invariant T (MAIT) cells. The final study visit will be at
      day 90 after the study agent administration. The investigators hypothesize that NT-I7 is safe
      for administration and preserves lymphocyte homeostasis in patients with mild COVID-19.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double-Blind.
measure: Evaluate the safety of a single dose of NT-I7 in a dose escalation fashion
time frame: Up to approximately 30 days
description: Assessment of the number and severity of AEs possibly, probably, or definitely related to study drug evaluated at 7 and 30 days.
measure: Evaluate the immunological effects of NT-I7 cumulatively for all doses on peripheral lymphocyte counts in COVID-19 patients.
time frame: Up to approximately 30 days
description: Assessment of the trajectory of ALC, CD4, CD8, NK, B, and MAIT cells measured at days 7, 14 and 30 after administration of NT-I7 or placebo compared to baseline values.
arm group label: NT-I7
arm group type: Experimental
description: NT-I7 will be administered once by IM injection within 24 hours of baseline (day 0). The treatment course pursued in all enrolled participants will be a single dose. Dosing will be staggered with at least 72 hours between each study participant.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo will be administered once by IM injection within 24 hours of baseline (day 0). The treatment course pursued in all enrolled participants will be a single dose. Dosing will be staggered with at least 72 hours between each study participant.
intervention type: Drug
intervention name: Double-Blind NT-I7
description: Administered by intramuscular (IM) injection
arm group label: NT-I7
other name: rhIL-7-hyFc
other name: efineptakin alfa
intervention type: Drug
intervention name: Double-Blind Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 19 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No