An Early Phase 1 interventional study of COVID-19 Therapeutic Biologic Mix - NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix for percutaneous use in Covid19, sponsored by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair. Active, not recruiting at 1 site in United States. Open to participants aged 24 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair · Early Phase 1, Interventional, and Health services research
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.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's planned enrollment of 20 is below the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Inclusion Criteria:
Exclusion Criteria:
Therapeutic Biological Product Mix activity - NOVAVAX COVID-19 VACCINE 1.0 mL add into BCG Organism 50 MG
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
Also known as: NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix
Number of Participants with Moderate COVID-19:
* 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 or Critical Illness Severity
Time frame: Duration at least 28 days
Rate of Positive COVID-19 nucleic acid:
* 20 Moderate COVID-19 patients with controled cancers * Positive testing COVID-19 by standard RT-PCR assay immediately * COVID-19 nucleic acid testing, assessed by RT-PCR Assay Kit * Rate of Positive COVID-19 nucleic acid must be 100%
Time frame: Duration at least 28 days
Rate of Negative COVID-19 nucleic acid
* 20 Moderate COVID-19 patients with controlled cancers * NOVAVAX COVID-19 VACCINE 1.0 mL plus BCG Organism 50 MG Mix * By the percutaneous route with the multiple puncture device * Negative COVID-19 by standard RT-PCR assay after percutaneous use 3 weeks * COVID-19 nucleic acid testing, assessed by RT-PCR Assay Kit * Rate of Negative COVID-19 nucleic acid will be more than 80%
Time frame: Duration at least 28 days
20 COVID-19 Participants with IGRA blood test with COVID-19 spike protein antigen
Positive IGRA blood test with COVID-19 spike protein antigen after percutaneous use 21 days
Time frame: Duration at least 28 days
20 COVID-19 Participants with IGRA blood test with TB antigens
* Negative IGRA blood test with TB antigens before percutaneous use * Positive IGRA blood test with TB antigens after percutaneous use 21 days
Time frame: Duration at least 28 days
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair