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

Active Not RecruitingEARLY_Phase 1

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

Conditions: Covid19

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

Countries: United States

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 overview

Sex: ALL

Age: 24 Years to 64 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

North Bethesda, Maryland, United States