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| ID | Type | Description | Link |
|---|---|---|---|
| FWA00015357 | Registry Identifier | DHHS, OHRP | |
| IRB00009424 | Registry Identifier | IRB, DHHS | |
| IORG0007849 | Registry Identifier | IORG, DHHS | |
| NPI-1831468511 | Registry Identifier | HHS, Health Care Provider Individual | |
| NPI-1023387701 | Registry Identifier | HHS, Health Care Provider Organization | |
| IND165646 | Registry Identifier | IND, FDA |
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| Name | Class |
|---|---|
| UnitedHealthcare | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assess for therapeutic biologics activity (proof-of-concept) | Experimental | Therapeutic Biological Product Mix activity - NOVAVAX COVID-19 VACCINE 1.0 mL add into BCG Organism 50 MG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 Therapeutic Biologic Mix - NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix for percutaneous use | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Moderate COVID-19: |
| Duration at least 28 days |
| Rate of Positive COVID-19 nucleic acid: |
| Duration at least 28 days |
| Rate of Negative COVID-19 nucleic acid |
| 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 | Duration at least 28 days |
| 20 COVID-19 Participants with IGRA blood test with TB antigens |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| HAN XU, MD/PhD/FAPCR | Medicine Invention Design, Inc. (MIDI) - IORG0007849 | Study Chair |
| HAN XU, MD/PhD/FAPCR | Medicine Invention Design, Inc. (MIDI) - IORG0007849 | Study Director |
| HAN XU, MD/PhD/FAPCR | Medicine Invention Design, Inc. (MIDI) - IORG0007849 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicine Invention Design Incorporation (MIDI) - IORG0007849 | North Bethesda | Maryland | 20852 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27102489 | Background | 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. | |
| 32132681 | Background | 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. |
| Label | URL |
|---|---|
| FWA00015357 | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 4, 2025 | Jun 6, 2025 |
Not provided
Single Usage / Single Dosage
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Open Label
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|
| Duration at least 28 days |
| 30619296 | Background | 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. |
| 32660100 | Background | 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. |
| 32877576 | Background | 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. |
| 32314460 | Background | 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. |
| 32401723 | Background | 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. |
| 32437697 | Background | 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. |
| 32479979 | Background | 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. |
| IRB00009424 | View source |
| IORG0007849 | View source |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 4, 2025 | Jun 6, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 4, 2025 | Jun 6, 2025 | ICF_002.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000711928 | NVX-CoV2373 adjuvated lipid nanoparticle |
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