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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-18

Study Completion Date

2026-07-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating HPV

NCT06959563

HPV Infection

ACTIVE_NOT_RECRUITING EARLY_PHASE1

Phase II/III Randomized Clinical Trial of Booster Dose of COVID-19 (Recombinant, Inactivated) Vaccine

NCT05354024

Coronavirus Infections Healthy

COMPLETED PHASE2/PHASE3

The Efficacy of the 2023-2024 Updated COVID-19 Vaccines Against COVID-19 Infection

NCT06065176

COVID-19 Vaccine-Preventable Diseases SARS CoV 2 Infection +2 more

COMPLETED PHASE4

An Open Comprative Study of the Prophylactic Efficacy and a Non-comparative Study of the Immunogenicity and Safety of the Inactivated Whole-virion Concentrated Purified Coronavirus Vaccine (CoviVac)

NCT05407142

Coronavirus Infections Vaccine

UNKNOWN PHASE3

Evaluating the Safety, Tolerability and Immunogenicity of bacTRL-Spike Vaccine for Prevention of COVID-19

NCT04334980

COVID-19

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Usage / Single Dosage

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Open Label

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Assess for therapeutic biologics activity (proof-of-concept)

Therapeutic Biological Product Mix activity - NOVAVAX COVID-19 VACCINE 1.0 mL add into BCG Organism 50 MG

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

24 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

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

M.D., Ph.D., FAPCR, Sponsor-Investigator, Medical Director, IORG Director, Medical Monitor, Safety Officer, IRB Chair

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

HAN XU, MD/PhD/FAPCR

Role: STUDY_CHAIR

Medicine Invention Design, Inc. (MIDI) - IORG0007849

HAN XU, MD/PhD/FAPCR

Role: STUDY_DIRECTOR

Medicine Invention Design, Inc. (MIDI) - IORG0007849

HAN XU, MD/PhD/FAPCR

Role: PRINCIPAL_INVESTIGATOR

Medicine Invention Design, Inc. (MIDI) - IORG0007849

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medicine Invention Design Incorporation (MIDI) - IORG0007849

North Bethesda, Maryland, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Netea MG, Joosten LA, Latz E, Mills KH, Natoli G, Stunnenberg HG, O'Neill LA, Xavier RJ. Trained immunity: A program of innate immune memory in health and disease. Science. 2016 Apr 22;352(6284):aaf1098. doi: 10.1126/science.aaf1098. Epub 2016 Apr 21.

Reference Type BACKGROUND

PMID: 27102489 (View on PubMed)

Netea MG, Dominguez-Andres J, Barreiro LB, Chavakis T, Divangahi M, Fuchs E, Joosten LAB, van der Meer JWM, Mhlanga MM, Mulder WJM, Riksen NP, Schlitzer A, Schultze JL, Stabell Benn C, Sun JC, Xavier RJ, Latz E. Defining trained immunity and its role in health and disease. Nat Rev Immunol. 2020 Jun;20(6):375-388. doi: 10.1038/s41577-020-0285-6. Epub 2020 Mar 4.

Reference Type BACKGROUND

PMID: 32132681 (View on PubMed)

Sanchez-Ramon S, Conejero L, Netea MG, Sancho D, Palomares O, Subiza JL. Trained Immunity-Based Vaccines: A New Paradigm for the Development of Broad-Spectrum Anti-infectious Formulations. Front Immunol. 2018 Dec 17;9:2936. doi: 10.3389/fimmu.2018.02936. eCollection 2018.

Reference Type BACKGROUND

PMID: 30619296 (View on PubMed)

Guevara-Hoyer K, Saz-Leal P, Diez-Rivero CM, Ochoa-Grullon J, Fernandez-Arquero M, Perez de Diego R, Sanchez-Ramon S. Trained Immunity Based-Vaccines as a Prophylactic Strategy in Common Variable Immunodeficiency. A Proof of Concept Study. Biomedicines. 2020 Jul 9;8(7):203. doi: 10.3390/biomedicines8070203.

Reference Type BACKGROUND

PMID: 32660100 (View on PubMed)

Keech C, Albert G, Cho I, Robertson A, Reed P, Neal S, Plested JS, Zhu M, Cloney-Clark S, Zhou H, Smith G, Patel N, Frieman MB, Haupt RE, Logue J, McGrath M, Weston S, Piedra PA, Desai C, Callahan K, Lewis M, Price-Abbott P, Formica N, Shinde V, Fries L, Lickliter JD, Griffin P, Wilkinson B, Glenn GM. Phase 1-2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine. N Engl J Med. 2020 Dec 10;383(24):2320-2332. doi: 10.1056/NEJMoa2026920. Epub 2020 Sep 2.

Reference Type BACKGROUND

PMID: 32877576 (View on PubMed)

Wollina U. Challenges of COVID-19 pandemic for dermatology. Dermatol Ther. 2020 Sep;33(5):e13430. doi: 10.1111/dth.13430. Epub 2020 Apr 30.

Reference Type BACKGROUND

PMID: 32314460 (View on PubMed)

Catala Gonzalo A, Galvan Casas C. COVID-19 and the Skin. Actas Dermosifiliogr (Engl Ed). 2020 Jul-Aug;111(6):447-449. doi: 10.1016/j.ad.2020.04.007. Epub 2020 May 13. No abstract available. English, Spanish.

Reference Type BACKGROUND

PMID: 32401723 (View on PubMed)

Guarneri C, Rullo EV, Pavone P, Berretta M, Ceccarelli M, Natale A, Nunnari G. Silent COVID-19: what your skin can reveal. Lancet Infect Dis. 2021 Jan;21(1):24-25. doi: 10.1016/S1473-3099(20)30402-3. Epub 2020 May 18. No abstract available.

Reference Type BACKGROUND

PMID: 32437697 (View on PubMed)

Freeman EE, McMahon DE, Lipoff JB, Rosenbach M, Kovarik C, Takeshita J, French LE, Thiers BH, Hruza GJ, Fox LP; American Academy of Dermatology Ad Hoc Task Force on COVID-19. Pernio-like skin lesions associated with COVID-19: A case series of 318 patients from 8 countries. J Am Acad Dermatol. 2020 Aug;83(2):486-492. doi: 10.1016/j.jaad.2020.05.109. Epub 2020 May 30.

Reference Type BACKGROUND

PMID: 32479979 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.