<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/NCT04428073</url>
  </required_header>
  <id_info>
    <org_study_id>GC004</org_study_id>
    <nct_id>NCT04428073</nct_id>
  </id_info>
  <brief_title>Therapeutic Vaccine Trial of COVID-19 for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection</brief_title>
  <official_title>A Phase I Trial of a Therapeutic Vaccine (Covax-19™) in SARS-CoV-2 Infected Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GeneCure Biotechnologies</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GeneCure Biotechnologies</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>
      GC004 is a Phase I trial to evaluate the safety and the immune responses of a therapeutic&#xD;
      vaccine in SARS-CoV-2 infected patients. Covid-19 confirmed patients with mild or no symptoms&#xD;
      will be enrolled sequentially into low dose and high dose groups. Following the vaccination&#xD;
      subjects who received at least one vaccination will be followed for safety through week 26.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">July 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate the safety of a therapeutic Covid-19 vaccine in participants by measuring the severity of local and systemic adverse events and laboratory abnormalities.</measure>
    <time_frame>26 weeks</time_frame>
    <description>Frequency and severity of adverse events, laboratory abnormalities, local and systemic reactogenicity, signs and symptoms after vaccinations.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the immunogenicity of a therapeutic Covid-19 vaccine in participants by measuring CD8+ T cells immune response</measure>
    <time_frame>6 weeks</time_frame>
    <description>Magnitude of IFN-γ producing CD8+ T cells to SARS-CoV-2 nucleocapsid peptides pools after vaccinations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Virologic response after vaccination</measure>
    <time_frame>4 weeks</time_frame>
    <description>Detection of SARS-CoV-2 by RT-PCR in respiratory tract specimens at week 0, 1, 2, 3, and 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical outcome and progression after vaccinations</measure>
    <time_frame>6 weeks</time_frame>
    <description>Number of participants with moderate, severe or critical Covid-19 at week 6.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">32</enrollment>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>Low dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive 1.0 mL of low dose vaccine at week 0 and 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive 1.0 mL of high dose vaccine at week 0 and 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Covax-19™</intervention_name>
    <description>Therapeutic vaccine for SARS-CoV-2 infection</description>
    <arm_group_label>High dose group</arm_group_label>
    <arm_group_label>Low dose group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Documentation of Covid-19 infection based on laboratory evidence of positivity by RT-&#xD;
             PCR.&#xD;
&#xD;
          2. Patients who have no clinical symptoms (fever, cough and dyspnea).&#xD;
&#xD;
          3. Patients who have mild clinical symptoms that could include fever, cough, sore throat,&#xD;
             malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath&#xD;
             (dyspnea).&#xD;
&#xD;
          4. Screening laboratory values within institutional normal range or judged to be not&#xD;
             clinically significant by clinical investigator.&#xD;
&#xD;
          5. Ability and willingness of subject to give written informed consent.&#xD;
&#xD;
          6. Negative pregnancy test on the day prior to each vaccination.&#xD;
&#xD;
          7. Willingness to use adequate contraception by study participants.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of respiratory and cardiovascular diseases, hematologic disease (e.g.,&#xD;
             cryoglobulinemia, lymphoma), renal disease, dermatologic disease (e.g., lichen planus,&#xD;
             porphyria cutanea tarda).&#xD;
&#xD;
          2. Autoimmune diseases or clinically serious cardiac, pulmonary, gastrointestinal,&#xD;
             hepatic, renal or neurologic disease, which in the opinion of the investigator will&#xD;
             compromise ability to participate in the study.&#xD;
&#xD;
          3. Pregnancy and breast-feeding.&#xD;
&#xD;
          4. Prior or current systemic cancer chemotherapy.&#xD;
&#xD;
          5. Investigational agents and immunomodulators (cyclosporine, hematological growth&#xD;
             factors, systemic corticosteroids, interleukins or interferons) within 90 days prior&#xD;
             to study entry.&#xD;
&#xD;
          6. Anaphylaxis or allergy to vaccine components.&#xD;
&#xD;
          7. Active drug or alcohol use or dependence that, in the opinion of the investigator,&#xD;
             would interfere with adherence to study requirements.&#xD;
&#xD;
          8. Any other serious diseases other than Covid-19 infection including current or recent&#xD;
             (within 5 years) cancers.&#xD;
&#xD;
          9. Subjects who are immunocompromised or immunosuppressed due to disease or medications.&#xD;
&#xD;
         10. Women who are lactating.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Frank Tung, Ph.D</last_name>
    <phone>17702637508</phone>
    <email>info@genecure.com</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SARS-CoV-2</keyword>
  <keyword>COVID-19</keyword>
  <keyword>therapeutic vaccine</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The final study results will be published in peer reviewed journals.</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/NCT04428073
org study id: GC004
nct id: NCT04428073
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
GC004 is a Phase I trial to evaluate the safety and the immune responses of a therapeutic
      vaccine in SARS-CoV-2 infected patients. Covid-19 confirmed patients with mild or no symptoms
      will be enrolled sequentially into low dose and high dose groups. Following the vaccination
      subjects who received at least one vaccination will be followed for safety through week 26.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To evaluate the safety of a therapeutic Covid-19 vaccine in participants by measuring the severity of local and systemic adverse events and laboratory abnormalities.
time frame: 26 weeks
description: Frequency and severity of adverse events, laboratory abnormalities, local and systemic reactogenicity, signs and symptoms after vaccinations.
measure: To evaluate the immunogenicity of a therapeutic Covid-19 vaccine in participants by measuring CD8+ T cells immune response
time frame: 6 weeks
description: Magnitude of IFN-γ producing CD8+ T cells to SARS-CoV-2 nucleocapsid peptides pools after vaccinations.
measure: Virologic response after vaccination
time frame: 4 weeks
description: Detection of SARS-CoV-2 by RT-PCR in respiratory tract specimens at week 0, 1, 2, 3, and 4.
measure: Clinical outcome and progression after vaccinations
time frame: 6 weeks
description: Number of participants with moderate, severe or critical Covid-19 at week 6.
arm group label: Low dose group
arm group type: Experimental
description: Subjects will receive 1.0 mL of low dose vaccine at week 0 and 2.
arm group label: High dose group
arm group type: Experimental
description: Subjects will receive 1.0 mL of high dose vaccine at week 0 and 2.
intervention type: Biological
intervention name: Covax-19™
description: Therapeutic vaccine for SARS-CoV-2 infection
arm group label: High dose group
arm group label: Low dose group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Frank Tung, Ph.D
phone: 17702637508
email: info@genecure.com
responsible party type: Sponsor
sharing ipd: No
ipd description: The final study results will be published in peer reviewed journals.