Proof-of-Concept Clinical Pharmacology Trial for COVID-19 Antigen Presentation Therapeutic Biologic Mix

Purpose

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 with controlled cancers. 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

  • Covid19

Eligibility

Eligible Ages
Between 24 Years and 64 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Controlled Cancers - 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. Uncontrolled Cancers - 2. Severe or Critical Illness Severity - 3. Pregnancy - 4. Breast-feeding - 5. The patients with other serious inter-current illness - 6. Serious Allergy - 7. Serious Bleed Tendency - 8. The prohibition of the biological product

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Single Usage / Single Dosage
Primary Purpose
Health Services Research
Masking
None (Open Label)
Masking Description
Open Label

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Assess for therapeutic biologics activity (proof-of-concept) 		Therapeutic Biological Product Mix activity - NOVAVAX COVID-19 VACCINE 1.0 mL add into BCG Organism 50 MG
  • Biological: COVID-19 Therapeutic Biologic Mix - NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix for percutaneous use
    - By the percutaneous route with the multiple puncture device - NOVAVAX COVID-19 VACCINE 1.0 mL plus BCG Organism 50 MG Mix
    Other names:
    • NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix

Recruiting Locations

More Details

NCT ID
NCT03305341
Status
Active, not recruiting
Sponsor
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

Detailed Description

- Conducting an initial small, controlled trial to assess therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of COVID-19 patients with controlled cancers. - 20 Moderate COVID-19 patients with controlled cancers - 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 - Novavax COVID-19 Vaccine 1.0 mL plus BCG Organism 50 MG Mix - By the percutaneous route with the multiple puncture device - Negative testing COVID-19 by standard RT-PCR assay or equivalent testing after injection 3 weeks. - Positive IGRA blood test with COVID-19 spike protein antigen after percutaneous use 21 days. - Our trial duration will be 4 weeks.