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

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 Biologics - Spike-GM-CSF Protein Lactated Ringer's Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT03305341

IRB00009424 (Registry Identifier)

NDA215451 (Registry Identifier)

BLA761218 (Registry Identifier)

FWA00015357 (Registry Identifier)

IND153210 (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.

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 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 22 to 72 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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
• 2. Pregnancy
• 3. Breast-feeding
• 4. The patients with other serious inter-current illness
• 5. Serious Allergy
• 6. Serious Bleed Tendency
• 7. The prohibition of the biological product

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

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

Experimental group

Description:

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

Treatment:

Biological: COVID-19 Therapeutic Biologics - Spike-GM-CSF Protein Lactated Ringer's Injection