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

Covid19 Clinical Trial

— COV19-APTP-B  

Official 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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03305341
• Other study ID #: IND153210
• Secondary ID: FWA00015357IRB00
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: July 18, 2020
• Est. completion date: July 28, 2024

Study information

• Verified date: March 2023
• Source: Medicine Invention Design, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Description:

• Conducting an initial small, controlled trial to assess for therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of COVID-19 patients.

• 20 Moderate COVID-19 patients

• 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

• Our trial duration will be 4-week duration.

• 0.1mg / 0.5 ml COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection

• Intradermic Injection, ID

• Negative testing COVID-19 by standard RT-PCR assay or equivalent testing after injection 2 weeks.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: July 28, 2024
• Est. primary completion date: July 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 72 Years

Eligibility

• Conducting an initial small, controlled trial to assess for therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of COVID-19 patients.

• 20 Moderate COVID-19 patients

Inclusion Criteria:

• 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. Severe or Critical Illness Severity

• 2. Pregnancy

• 3. Breast-feeding

• 4. The patients with other serious inter-current illness

• 5. Serious Allergy

• 6. Serious Bleed Tendency

• 7. The prohibition of the biological product

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Biological:
• COVID-19 Therapeutic Biologics - Spike-GM-CSF Protein Lactated Ringer's Injection
Intradermic Injection, ID COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection

Locations

Country	Name	City	State
United States	Medicine Invention Design Incorporation (MIDI) - IORG0007849	North Bethesda	Maryland

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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. — View Citation

Gottlieb M, Long B. Dermatologic manifestations and complications of COVID-19. Am J Emerg Med. 2020 Sep;38(9):1715-1721. doi: 10.1016/j.ajem.2020.06.011. Epub 2020 Jun 6. — View Citation

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. — View Citation

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. — View Citation

Gul U. COVID-19 and dermatology. Turk J Med Sci. 2020 Dec 17;50(8):1751-1759. doi: 10.3906/sag-2005-182. — View Citation

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. — View Citation

Klejtman T. Skin and COVID-19. J Med Vasc. 2020 Jul;45(4):175-176. doi: 10.1016/j.jdmv.2020.06.001. No abstract available. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Moderate COVID-19:	20 Moderate COVID-19 patients; 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	Duration at least 28 days
Primary	Rate of Positive COVID-19 nucleic acid:	20 Moderate COVID-19 patients; 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%	Duration at least 28 days
Primary	Concentration of Active Ingredient:	0.1mg COVID-19 Spike-GM-CSF Protein; 0.5 ml Lactated Ringer's Injection, USP; 0.1mg / 0.5 ml COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection	Duration at least 28 days
Primary	Rate of Negative COVID-19 nucleic acid	20 Moderate COVID-19 patients; 0.1mg / 0.5 ml COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection; Intradermic Injection, ID; Negative COVID-19 by standard RT-PCR assay after injection 2 weeks; COVID-19 nucleic acid testing, assessed by RT-PCR Assay Kit; Rate of Negative COVID-19 nucleic acid will be more than 80%	Duration at least 28 days

External Links

•   FWA00015357
•   IORG0007849
•   IRB00009424