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NCT03305341: COVSP-BCG
Proof-of-Concept Clinical Pharmacology Trial for COVID-19 Antigen Presentation Therapeutic Biologic Mix
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.
18 July 2026
Quick facts
| Lead sponsor | Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 20 |
| Start date | 18 May 2025 |
| Primary completion | 18 July 2026 |
| Estimated completion | 28 July 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- COVID-19 Therapeutic Biologic Mix - NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix for percutaneous use
Conditions studied
- Covid19 — all drugs for Covid19 →
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):
-
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 -
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 -
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:
- PubMed search for NCT03305341
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Covid19
Currently open trials in the same condition.
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- NCT04924803 — Community Developed Technology-Based Messaging to Increase COVID-19 Vaccine Uptake Among People Who Inject Drugs · NA · active not recruiting
- NCT05013632 — COVID-19 International Drug Pregnancy Registry · recruiting
- NCT04806061 — Urine Alkalinisation in COVID-19 · NA · active not recruiting
- NCT04802408 — SARS-Cov-2 (COVID-19) Nasal Pharyngeal and Oral Pharyngeal Wash (SNOW) Trial · Phase 2, PHASE3 · active not recruiting
Other Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair trials
Trials by the same sponsor.
- NCT05987956 — Pharmacogenomics IND EXEMPT SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms · Phase 2, PHASE3 · active not recruiting
- NCT07182838 — Proof-of-Concept Clinical Pharmacology Trial for HIV Antigen Presentation Therapeutic Biologic Mix · EARLY_PHASE1 · active not recruiting
- NCT07145333 — Pharmacogenomics ANDA SNP Clinical Study - Topotecan and Single Nucleotide Polymorphisms · Phase 2, PHASE3 · active not recruiting
- NCT01064466 — Pharmacogenomics ANDA SNP Clinical Study - Etoposide and Single Nucleotide Polymorphisms · Phase 2, PHASE3 · active not recruiting
- NCT06062810 — Bioequivalence ANDA SNP Clinical Study - Raloxifene and Single Nucleotide Polymorphisms · Phase 2, PHASE3 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03305341 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
- Last refreshed: 11 June 2025
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