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

NCT03305341 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-06-11

No results posted yet for this 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.

Conditions

  • Covid19

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

Sponsors & Collaborators

  • UnitedHealthcare

    collaborator OTHER

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

    lead INDUSTRY

Principal Investigators

  • HAN XU, MD/PhD/FAPCR · Medicine Invention Design, Inc. (MIDI) - IORG0007849

  • HAN XU, MD/PhD/FAPCR · Medicine Invention Design, Inc. (MIDI) - IORG0007849

  • HAN XU, MD/PhD/FAPCR · Medicine Invention Design, Inc. (MIDI) - IORG0007849

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
24 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-18
Primary Completion
2026-07-18
Completion
2026-07-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03305341 on ClinicalTrials.gov