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ACTIVE NOT RECRUITING
NCT03305341
EARLY_PHASE1

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

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

View on ClinicalTrials.gov

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.

Official title: Conducting an Initial Small, Controlled Clinical Pharmacology Trial to Assess for Therapeutic Biologics Activity (Proof-of-Concept) That Suggests the Potential for Clinical Benefits of COVID-19 Patients With Controlled Cancers.

Key Details

Gender

All

Age Range

24 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-05-18

Completion Date

2026-07-28

Last Updated

2025-06-11

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

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

Locations (1)

Medicine Invention Design Incorporation (MIDI) - IORG0007849

North Bethesda, Maryland, United States