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

Early Phase 1Active Not RecruitingNCT03305341

Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair20 enrolled

Overview

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.

* 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 24 YearsMax age: 64 Years

Medical Language ↔ Plain English

* 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

Outcomes

Primary Outcomes

Number of Participants with Moderate COVID-19:

* 20 Moderate COVID-19 patients with controlled cancers * Moderate COVID-19 * Positive testing by standard RT-PCR assay * 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