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AD26-BCG: Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating COVID-19

Sponsor
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02403505
Collaborator
PPD (Industry)
20
Enrollment
2
Locations
1
Arm
8
Anticipated Duration (Months)
10
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Conducting an early phase clinical trial to assess COVID-19 Antigen Presentation Therapeutic Biological Product Mix activity that suggests the potential for clinical benefit of COVID-19 patients.

  1. Treat Infection of Multiple Gene Mutation COVID-19 Virus Strains.

  2. Activate human COVID-19 Antigen Presentation Reaction.

  3. The human antigen presenting cells (APCs) can treat the COVID-19 virus antigens into small peptide fragments, and then kill COVID-19 virus directly.

Condition or Disease Intervention/Treatment Phase
  • Biological: Ad26 COVID-19 Spike plus TICE® BCG Mix for Intradermal Injection
 Early Phase 1

Detailed Description

  • Conducting an early phase clinical trial to assess COVID-19 Antigen Presentation Therapeutic Biological Product Mix activity that suggests the potential for clinical benefit of COVID-19 patients

  • 20 Lighter Than Mild COVID-19 Patients

  • Positive testing COVID-19 by standard RT-PCR assay

  • COVID-19 infection without symptoms

  • Symptoms of mild illness with COVID-19 that could include fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, and loss of taste or smell, without shortness of breath or dyspnea

  • No clinical signs indicative of Moderate, Severe, or Critical Severity

  • PPD negative participant is 10 TU skin test reading < 5 mm induration at 48 hours

  • Our trial duration will be 4-week duration.

  • Ad26 COVID-19 Spike 1.0 mL plus TICE® BCG Organism 50 MG Mix

  • Intradermic Injection, ID

  • Our trial duration will be 4-week duration

  • Negative testing COVID-19 by standard RT-PCR assay after injection 2 weeks

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single Usage Single DosageSingle Usage Single Dosage
Masking:
None (Open Label)
Masking Description:
Open Label
Primary Purpose:
Treatment
Official Title:
Conducting an Early Phase Clinical Trial to Assess for COVID-19 Antigen Presentation Therapeutic Biological Product Mix Activity That Suggests the Potential for Clinical Benefits of COVID-19 Patients.
Actual Study Start Date :
Dec 28, 2021
Anticipated Primary Completion Date :
Aug 28, 2022
Anticipated Study Completion Date :
Aug 28, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Assess for COVID-19 Antigen Presentation Therapeutic Biological Product Mix activity

Ad26 COVID-19 Spike Organism 1.0 mL TICE® BCG Organism 50 MG

Biological: Ad26 COVID-19 Spike plus TICE® BCG Mix for Intradermal Injection
Intradermic Injection, ID Ad26 COVID-19 Spike Organism 1.0 mL plus TICE® BCG Organism 50 MG Mix
Other Names:
  • Ad26 COVID-19 Spike Organism plus TICE® BCG Organism Mix

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 20 Participants with COVID-19 testing by standard RT-PCR assay [Duration at least 28 days]

      Negative testing COVID-19 by standard RT-PCR assay after injection 2 weeks

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    24 Years to 74 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Conducting an early phase clinical trial to assess COVID-19 Antigen Presentation Therapeutic Biological Product Mix that suggests the potential for clinical benefit of COVID-19 patients.

    20 Lighter Than Mild COVID-19 Patients

    Inclusion Criteria:

    • Lighter Than Mild COVID-19 Patients

    • Positive testing COVID-19 by standard RT-PCR assay

    • COVID-19 infection without symptoms

    • Symptoms of mild illness with COVID-19 that could include fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, and loss of taste or smell, without shortness of breath or dyspnea

    • No clinical signs indicative of Moderate, Severe, or Critical Severity

    • PPD negative participant is 10 TU skin test reading < 5 mm induration at 48 hours.

    Exclusion Criteria:

    • PPD positive participant is 10 TU skin test reading > 5 mm induration at 48 hours

    • Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion

    • Clinical signs suggestive of moderate illness with COVID-19

    • Symptoms suggestive of severe systemic illness with COVID-19, which could include any symptom of moderate illness or shortness of breath at rest, or respiratory distress

    • Clinical signs indicative of severe systemic illness with COVID-19

    • Evidence of critical illness

    • Respiratory failure

    • Shock

    • Multi-organ dysfunction / failure

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medicine Invention Design, Inc. (MIDI) - c/o - MIDINC Clinical Investigator Working Site Rockville Maryland United States 20853
    2 MIDI Clinical Trial Sites -c/o- Dr. Han Xu - Physicians / Investigators / Laboratories Operation Site Rockville Maryland United States 20853

    Sponsors and Collaborators

    • Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
    • PPD

    Investigators

    • Study Chair: HAN XU, M.D., Ph.D., IRB00009424
    • Study Director: HAN XU, M.D., Ph.D., IORG0007849
    • Principal Investigator: HAN XU, M.D., Ph.D., IORG0007849-FWA00015357

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair, M.D., Ph.D., Sponsor-Investigator, IORG Director, Monitor, IRB Chair, Medicine Invention Design, Inc
    ClinicalTrials.gov Identifier:
    NCT02403505
    Other Study ID Numbers:
    • IND 28299
    • FWA00015357
    • IORG0007849
    • IRB00009424
    • IND28299
    • NDA217392
    • BLA761321
    First Posted:
    Mar 31, 2015
    Last Update Posted:
    Mar 29, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair, M.D., Ph.D., Sponsor-Investigator, IORG Director, Monitor, IRB Chair, Medicine Invention Design, Inc
    Spike
    Escape Mutation
    ADE
    Antigen Presentation
    APC
    Trained Immunity
    Innate Immune Memory
    Additional relevant MeSH terms:
    COVID-19
    BCG Vaccine

    Study Results

    No Results Posted as of Mar 29, 2022