Proof-of-Concept Clinical Pharmacology Trial for COVID-19 Antigen Presentation Therapeutic Biologic Mix (COVSP-BCG)

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

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Covid19

Treatments: Biological: COVID-19 Therapeutic Biologic Mix - NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix for percutaneous use

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03305341

NPI-1831468511 (Registry Identifier)

IRB00009424 (Registry Identifier)

IND165646 (Registry Identifier)

FWA00015357 (Registry Identifier)

NPI-1023387701 (Registry Identifier)

IORG0007849 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 24 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Assess for therapeutic biologics activity (proof-of-concept)

Experimental group

Description:

Therapeutic Biological Product Mix activity - NOVAVAX COVID-19 VACCINE 1.0 mL add into BCG Organism 50 MG

Treatment:

Biological: COVID-19 Therapeutic Biologic Mix - NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix for percutaneous use