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NCT03305341: COVSP-BCG

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

Active, enrolled EARLY_PHASE1 Last updated 11 June 2025
What this trial tests

EARLY_PHASE1 trial testing COVID-19 Therapeutic Biologic Mix - NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix for percutaneous use in Covid19 in 20 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
18 May 2025
Primary endpoint
18 July 2026
28 July 2026

Quick facts

Lead sponsorHan Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
PhaseEARLY_PHASE1
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposehealth services research
Enrollment20
Start date18 May 2025
Primary completion18 July 2026
Estimated completion28 July 2026
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair — full company profile →

Who can join

Adults 24 to 64, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The 2020 race towards SARS-CoV-2 specific vaccines.
    Karpiński TM, Ożarowski M, Seremak-Mrozikiewicz A, Wolski H, et al · · 2021 · cited 65× · PMID 33408775 · DOI 10.7150/thno.53691
  2. Principles and Challenges in anti-COVID-19 Vaccine Development.
    Strizova Z, Smetanova J, Bartunkova J, Milota T. · · 2021 · cited 29× · PMID 33524979 · DOI 10.1159/000514225
  3. Immunoregulatory therapy strategies that target cytokine storms in patients with COVID-19 (Review).
    Wang X, He Z, Zhao X. · · 2021 · cited 8× · PMID 33732292 · DOI 10.3892/etm.2021.9750

Verify or expand the search:

Other recruiting trials for Covid19

Currently open trials in the same condition.

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

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03305341.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing