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NCT03305341 · ClinicalTrials.gov registry record · Early Phase 1
Proof-of-Concept Clinical Pharmacology Trial for COVID-19 Antigen Presentation Therapeutic Biologic Mix
A Early Phase 1 study of COVID-19, sponsored by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair.
- Active
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT03305341: Active Early Phase 1 study of COVID-19, sponsored by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair.
NCT03305341 is a Early Phase 1 study of COVID-19 that is active but no longer recruiting, run by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair. The registered enrollment target is 20 participants, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03305341, a Early Phase 1 study of COVID-19, is active but no longer recruiting, sponsored by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
* 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 o
Conditions Studied
Interventions
- BIOLOGICAL COVID-19 Therapeutic Biologic Mix - NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix for percutaneous use
Study Locations (1)
Maryland
- Medicine Invention Design Incorporation (MIDI) - IORG0007849 - North Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-05-18 |
| Est. Completion | 2026-07-28 |
| Phase | Early Phase 1 |
What the registry record for NCT03305341 still lists
NCT03305341 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 1 intervention - of which COVID-19 Therapeutic Biologic Mix - NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix for percutaneous use is the first listed.
NCT03305341 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03305341 about?
NCT03305341 is a clinical study titled "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. ...
What is the current status of trial NCT03305341?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2025-05-18. Estimated completion is 2026-07-28.
What conditions does trial NCT03305341 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT03305341?
The interventions under investigation include: COVID-19 Therapeutic Biologic Mix - NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix for percutaneous use (BIOLOGICAL).
Who is sponsoring clinical trial NCT03305341?
This trial is sponsored by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03305341 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03305341's enrollment target sits among peer trials
20 279th of 298 higher than 14 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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