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Therapeutic Vaccine Trial of COVID-19 for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04428073
Recruitment Status : Not yet recruiting
First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
GeneCure Biotechnologies

Tracking Information
First Submitted Date  ICMJE June 8, 2020
First Posted Date  ICMJE June 11, 2020
Last Update Posted Date June 11, 2020
Estimated Study Start Date  ICMJE July 2020
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2020)
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 ]
Frequency and severity of adverse events, laboratory abnormalities, local and systemic reactogenicity, signs and symptoms after vaccinations.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2020)
  • To evaluate the immunogenicity of a therapeutic Covid-19 vaccine in participants by measuring CD8+ T cells immune response [ Time Frame: 6 weeks ]
    Magnitude of IFN-γ producing CD8+ T cells to SARS-CoV-2 nucleocapsid peptides pools after vaccinations.
  • Virologic response after vaccination [ Time Frame: 4 weeks ]
    Detection of SARS-CoV-2 by RT-PCR in respiratory tract specimens at week 0, 1, 2, 3, and 4.
  • Clinical outcome and progression after vaccinations [ Time Frame: 6 weeks ]
    Number of participants with moderate, severe or critical Covid-19 at week 6.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Therapeutic Vaccine Trial of COVID-19 for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection
Official Title  ICMJE A Phase I Trial of a Therapeutic Vaccine (Covax-19™) in SARS-CoV-2 Infected Patients
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID
Intervention  ICMJE Biological: Covax-19™
Therapeutic vaccine for SARS-CoV-2 infection
Study Arms  ICMJE
  • Experimental: Low dose group
    Subjects will receive 1.0 mL of low dose vaccine at week 0 and 2.
    Intervention: Biological: Covax-19™
  • Experimental: High dose group
    Subjects will receive 1.0 mL of high dose vaccine at week 0 and 2.
    Intervention: Biological: Covax-19™
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 10, 2020)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Documentation of Covid-19 infection based on laboratory evidence of positivity by RT- PCR.
  2. Patients who have no clinical symptoms (fever, cough and dyspnea).
  3. Patients who have mild clinical symptoms that could include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath (dyspnea).
  4. Screening laboratory values within institutional normal range or judged to be not clinically significant by clinical investigator.
  5. Ability and willingness of subject to give written informed consent.
  6. Negative pregnancy test on the day prior to each vaccination.
  7. Willingness to use adequate contraception by study participants.

Exclusion Criteria:

  1. History of respiratory and cardiovascular diseases, hematologic disease (e.g., cryoglobulinemia, lymphoma), renal disease, dermatologic disease (e.g., lichen planus, porphyria cutanea tarda).
  2. Autoimmune diseases or clinically serious cardiac, pulmonary, gastrointestinal, hepatic, renal or neurologic disease, which in the opinion of the investigator will compromise ability to participate in the study.
  3. Pregnancy and breast-feeding.
  4. Prior or current systemic cancer chemotherapy.
  5. Investigational agents and immunomodulators (cyclosporine, hematological growth factors, systemic corticosteroids, interleukins or interferons) within 90 days prior to study entry.
  6. Anaphylaxis or allergy to vaccine components.
  7. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
  8. Any other serious diseases other than Covid-19 infection including current or recent (within 5 years) cancers.
  9. Subjects who are immunocompromised or immunosuppressed due to disease or medications.
  10. Women who are lactating.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Frank Tung, Ph.D 17702637508 info@genecure.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04428073
Other Study ID Numbers  ICMJE GC004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The final study results will be published in peer reviewed journals.
Responsible Party GeneCure Biotechnologies
Study Sponsor  ICMJE GeneCure Biotechnologies
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account GeneCure Biotechnologies
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP