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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study summary

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.

Eligibility

Primary outcome measure(s)

• Number of Participants with Moderate COVID-19: — Duration at least 28 days
  * 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
• Rate of Positive COVID-19 nucleic acid: — Duration at least 28 days
  * 20 Moderate COVID-19 patients with controled cancers * Positive testing COVID-19 by standard RT-PCR assay immediately * COVID-19 nucleic acid testing, assessed by RT-PCR Assay Kit * Rate of Positive COVID-19 nucleic acid must be 100%
• Rate of Negative COVID-19 nucleic acid — Duration at least 28 days
  * 20 Moderate COVID-19 patients with controlled cancers * NOVAVAX COVID-19 VACCINE 1.0 mL plus BCG Organism 50 MG Mix * By the percutaneous route with the multiple puncture device * Negative COVID-19 by standard RT-PCR assay after percutaneous use 3 weeks * COVID-19 nucleic acid testing, assessed by RT-PCR Assay Kit * Rate of Negative COVID-19 nucleic acid will be more than 80%
• 20 COVID-19 Participants with IGRA blood test with COVID-19 spike protein antigen — Duration at least 28 days
  Positive IGRA blood test with COVID-19 spike protein antigen after percutaneous use 21 days
• 20 COVID-19 Participants with IGRA blood test with TB antigens — Duration at least 28 days
  * Negative IGRA blood test with TB antigens before percutaneous use * Positive IGRA blood test with TB antigens after percutaneous use 21 days

Trial sites (1)

More Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair trials in the USA

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