Multiple Myeloma Clinical Trial

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

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.

Treat Infection of Multiple Gene Mutation COVID-19 Virus Strains.
Activate human COVID-19 Antigen Presentation Reaction.
The human antigen presenting cells (APCs) can treat the COVID-19 virus antigens into small peptide fragments, and then kill COVID-19 virus directly.

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Full 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

View Eligibility Criteria

Eligibility 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

Study is for people with:

Multiple Myeloma

Phase:

Early Phase 1

Estimated Enrollment:

20

Study ID:

NCT02403505

Recruitment Status:

Active, not recruiting

Sponsor:

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

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There is 1 Location for this study

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

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Early Phase 1

Estimated Enrollment:

20

Study ID:

NCT02403505

Recruitment Status:

Active, not recruiting

Sponsor:


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

How clear is this clinincal trial information?

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