Active Not RecruitingEarly Phase 1NCT03305341

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

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.

Checked against the public recordLast updated Jun 10, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhaseEarly Phase 1
U.S. locations1
SponsorHan Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
01
Study overview

What this study is about

Purpose
Health Services Research
Study type
Interventional
Phase
Early Phase 1
Sponsor
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Interventions being studied
Biological: COVID-19 Therapeutic Biologic Mix - NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix for percutaneous use
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

* 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Medicine Invention Design Incorporation (MIDI) - IORG0007849North Bethesda, Maryland

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 10, 2026. Always confirm current availability with the study team.

View original record ↗