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NCT Number: NCT03305341

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

24 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Medicine Invention Design Incorporation (MIDI) - IORG0007849

North Bethesda, Maryland, 20852, United States

About this study

  • 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
  • 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
  • Novavax COVID-19 Vaccine 1.0 mL plus BCG Organism 50 MG Mix
  • By the percutaneous route with the multiple puncture device
  • Negative testing COVID-19 by standard RT-PCR assay or equivalent testing after injection 3 weeks.
  • Positive IGRA blood test with COVID-19 spike protein antigen after percutaneous use 21 days.
  • Our trial duration will be 4 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

COVID-19 Therapeutic Biologic Mix - NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix for percutaneous use

Biological
  • By the percutaneous route with the multiple puncture device
  • NOVAVAX COVID-19 VACCINE 1.0 mL plus BCG Organism 50 MG Mix

Other names: NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix

Primary outcomes

  1. Number of Participants with Moderate COVID-19:

    Time frame: Duration at least 28 days

    • 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

  2. Rate of Positive COVID-19 nucleic acid:

    Time frame: Duration at least 28 days

    • 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%

  3. Rate of Negative COVID-19 nucleic acid

    Time frame: Duration at least 28 days

    • 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%

  4. 20 COVID-19 Participants with IGRA blood test with COVID-19 spike protein antigen

    Time frame: Duration at least 28 days

    Positive IGRA blood test with COVID-19 spike protein antigen after percutaneous use 21 days

  5. 20 COVID-19 Participants with IGRA blood test with TB antigens

    Time frame: Duration at least 28 days

    • Negative IGRA blood test with TB antigens before percutaneous use
    • Positive IGRA blood test with TB antigens after percutaneous use 21 days

Sponsors and collaborators

Lead sponsor

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

Industry

Collaborators

  • UnitedHealthcare

Registry information

Official study title

Conducting an Initial Small, Controlled Clinical Pharmacology Trial to Assess for Therapeutic Biologics Activity (Proof-of-Concept) That Suggests the Potential for Clinical Benefits of COVID-19 Patients With Controlled Cancers.

Acronym: COVSP-BCG

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 9, 2017
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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