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COV19-APTP-B: Proof-of-Concept Clinical Pharmacology Trial for COVID-19 Antigen Presentation Therapeutic Biologics

Sponsor
Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03305341
Collaborator
PPD (Industry)
20
Enrollment
1
Location
1
Arm
24.3
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Conducting an initial small, controlled clinical pharmacology trial to assess for therapeutic biologics activity (proof-of-concept) 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 Antigen Presentation Reaction to COVID-19 Specific Antigen.

  3. The human antigen presenting cells (APCs) can take up and process COVID-19 target antigen protein into small peptide fragments, and then COVID-19 virus can be killed by APCs directly.

Condition or Disease Intervention/Treatment Phase
  • Biological: COVID-19 Therapeutic Biologics - Spike-GM-CSF Protein Lactated Ringer's Injection
 Early Phase 1

Detailed Description

  • Conducting an initial small, controlled trial to assess for therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of COVID-19 patients.

  • 20 Moderate COVID-19 patients

  • Moderate COVID-19

  • Positive testing by standard RT-PCR assay or equivalent testing

  • 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, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) > 93% on room air at sea level, heart rate ≥ 90 beats per minute

  • No clinical signs indicative of Severe or Critical Illness Severity

  • Our trial duration will be 4-week duration.

  • 0.1mg / 0.5 ml COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection

  • Intradermic Injection, ID

  • Negative testing COVID-19 by standard RT-PCR assay or equivalent testing 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 Initial Small, Controlled Clinical Pharmacology Trial to Assess for Therapeutic Biologics Activity (Proof-of-Concept) That Suggests the Potential for Clinical Benefits of COVID-19 Patients.
Actual Study Start Date :
Jul 18, 2020
Anticipated Primary Completion Date :
Jun 28, 2022
Anticipated Study Completion Date :
Jul 28, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Assess for therapeutic biologics activity (proof-of-concept)

0.1mg Spike-GM-CSF Protein 0.5 ml Lactated Ringer's Injection, USP

Biological: COVID-19 Therapeutic Biologics - Spike-GM-CSF Protein Lactated Ringer's Injection
Intradermic Injection, ID COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection
Other Names:
  • COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Moderate COVID-19: [Duration at least 28 days]

      20 Moderate COVID-19 patients Moderate COVID-19 Positive testing by standard RT-PCR assay 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, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) > 93% on room air at sea level, heart rate ≥ 90 beats per minute No clinical signs indicative of Severe or Critical Illness Severity

    2. Rate of Positive COVID-19 nucleic acid: [Duration at least 28 days]

      20 Moderate COVID-19 patients Positive testing COVID-19 by standard RT-PCR assay immediately COVID-19 nucleic acid testing, assessed by RT-PCR Assay Kit Rate of Positive COVID-19 nucleic acid must be 100%

    3. Concentration of Active Ingredient: [Duration at least 28 days]

      0.1mg COVID-19 Spike-GM-CSF Protein 0.5 ml Lactated Ringer's Injection, USP 0.1mg / 0.5 ml COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection

    4. Rate of Negative COVID-19 nucleic acid [Duration at least 28 days]

      20 Moderate COVID-19 patients 0.1mg / 0.5 ml COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection Intradermic Injection, ID Negative COVID-19 by standard RT-PCR assay after injection 2 weeks COVID-19 nucleic acid testing, assessed by RT-PCR Assay Kit Rate of Negative COVID-19 nucleic acid will be more than 80%

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years to 72 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    • Conducting an initial small, controlled trial to assess for therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of COVID-19 patients.

    • 20 Moderate COVID-19 patients

    Inclusion Criteria:

    • Moderate COVID-19

    • Positive testing by standard RT-PCR assay or equivalent testing

    • 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, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) > 93% on room air at sea level, heart rate ≥ 90 beats per minute

    • No clinical signs indicative of Severe or Critical Illness Severity

    Exclusion Criteria:
      1. Severe or Critical Illness Severity
      1. Pregnancy
      1. Breast-feeding
      1. The patients with other serious inter-current illness
      1. Serious Allergy
      1. Serious Bleed Tendency
      1. The prohibition of the biological product

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medicine Invention Design Incorporation (MIDI) - IORG0007849 North Bethesda Maryland United States 20852

    Sponsors and Collaborators

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

    Investigators

    • Study Chair: HAN XU, M.D., Ph.D., Medicine Invention Design, Inc. (MIDI) - IORG0007849
    • Study Director: HAN XU, M.D., Ph.D., Medicine Invention Design, Inc. (MIDI) - IORG0007849
    • Principal Investigator: HAN XU, M.D., Ph.D., Medicine Invention Design, Inc. (MIDI) - IORG0007849

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair, M.D., Ph.D., Sponsor-Investigator, IORG Director, Monitor, IRB Chair, Medicine Invention Design, Inc
    ClinicalTrials.gov Identifier:
    NCT03305341
    Other Study ID Numbers:
    • IND153210
    • FWA00015357
    • IRB00009424
    • IORG0007849
    • IND153210
    • NDA215451
    • BLA761218
    First Posted:
    Oct 9, 2017
    Last Update Posted:
    Dec 6, 2021
    Last Verified:
    Dec 1, 2021
    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
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair, M.D., Ph.D., Sponsor-Investigator, IORG Director, Monitor, IRB Chair, Medicine Invention Design, Inc
    Gene Mutation
    Antigen Presentation
    APC
    Spike
    COVID-19
    Additional relevant MeSH terms:
    COVID-19
    Molgramostim
    Sargramostim

    Study Results

    No Results Posted as of Dec 6, 2021