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Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating COVID-19 (Spike-BCG)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02403505
Recruitment Status : Active, not recruiting
First Posted : March 31, 2015
Last Update Posted : January 20, 2023
Sponsor:
Information provided by (Responsible Party):
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair, Medicine Invention Design, Inc

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
COVID-19 Biological: Recombinant COVID-19 Spike Protein plus TICE® BCG Mix for percutaneous use 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.
  • COVID-19 Spike Protein 1.0 mL plus TICE® BCG Organism 50 MG Mix
  • By the percutaneous route with the multiple puncture device
  • Our trial duration will be 4-week duration
  • Negative testing COVID-19 by standard RT-PCR assay after percutaneous 10 days

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
  • Single 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 : December 28, 2021
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Assess for COVID-19 Antigen Presentation Therapeutic Biological Product Mix activity
Recombinant COVID-19 Spike Protein 0.01 MG, 1.0 mL add into TICE® BCG Organism 50 MG
Biological: Recombinant COVID-19 Spike Protein plus TICE® BCG Mix for percutaneous use
  • By the percutaneous route with the multiple puncture device
  • Recombinant COVID-19 Spike Protein 0.01 MG, 1.0 mL plus TICE® BCG Organism 50 MG Mix
Other Name: Recombinant COVID-19 Spike Protein plus TICE® BCG Organism Mix




Primary Outcome Measures :
  1. 20 Participants with COVID-19 testing by standard RT-PCR assay [ Time Frame: Duration at least 28 days ]
    Negative testing COVID-19 by standard RT-PCR assay after percutaneous 10 days



Information from the National Library of Medicine

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Ages Eligible for Study:   24 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • Pregnant
  • Thrombosis
  • Myocarditis
  • Pericarditis
  • Allergy
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02403505


Locations
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United States, Maryland
Medicine Invention Design, Inc. (MIDI) - c/o - MIDINC Clinical Investigator Working Site
Rockville, Maryland, United States, 20853
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
Investigators
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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)

Documents provided by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair, Medicine Invention Design, Inc:
Study Protocol  [PDF] November 3, 2022
Informed Consent Form  [PDF] November 3, 2022

Additional Information:
Publications:
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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 165646
FWA00015357 ( Registry Identifier: Federalwide Assurance (FWA) DHHS OHRP )
IORG0007849 ( Registry Identifier: Institution or Organization (IORG) DHHS OHRP )
IRB00009424 ( Registry Identifier: Institutional Review Board (IRB) DHHS OHRP )
IND165646 ( Registry Identifier: Investigational New Drug Application (IND) FDA )
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: January 20, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Medicine Invention Design, Inc:
Spike
Escape Mutation
ADE
Antigen Presentation
APC
Trained Immunity
Innate Immune Memory
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Myeloma Proteins
Paraproteins
BCG Vaccine
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic