Discovery Stage COVID-19 Antigen Presentation Therapeutic Biologics Mix to Treat COVID-19 Virus Infection (ApTpBioMix)

• ClinicalTrials.gov Identifier: NCT03348670
• Recruitment Status: Active, not recruiting
• First Posted: November 21, 2017
• Last Update Posted: January 14, 2022
• Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
• Information provided by (Responsible Party): Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair, Medicine Invention Design, Inc

Study Description

Brief Summary:

Conducting an initial, small, controlled clinical trial to assess for COVID-19 Antigen Presentation Therapeutic Biologics Mix activity 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 COVID-19 Antigen Presentation Reaction.
3. The human antigen presenting cells (APCs) can treat the COVID-19 virus antigens into small peptide fragments, and then kill COVID-19 virus directly.

Condition or disease	Intervention/treatment	Phase
Covid19	Biological: CoronaVac® plus TICE® BCG Mix for Intradermal Injection	Early Phase 1

Detailed Description:

• Conducting an initial, small, controlled clinical trial to assess for COVID-19 Antigen Presentation Therapeutic Biologics Mix activity that suggests the potential for clinical benefit of COVID-19 patients
• 20 Lower Than Mild COVID-19 Patients
• Positive testing COVID-19 by standard RT-PCR assay
• COVID-19 infection without symptoms
• Symptoms of mild illness with COVID-19 that could include fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, and loss of taste or smell, without shortness of breath or dyspnea
• No clinical signs indicative of Moderate, Severe, or Critical Severity
• PPD negative participant is 10 TU skin test reading < 5 mm induration at 48 hours
• Our trial duration will be 4-week duration.
• CoronaVac® Organism 1.0 mL plus TICE® BCG Organism 50 MG Mix
• Intradermic Injection, ID
• Our trial duration will be 4-week duration
• Negative testing COVID-19 by standard RT-PCR assay after injection 2 weeks

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment

Intervention Model Description

• Single Usage
• Single Dosage

• Masking: None (Open Label)
• Masking Description: Open Label
• Primary Purpose: Treatment
• Official Title: Conducting an Initial, Small, Controlled Clinical Trial to Assess for COVID-19 Antigen Presentation Therapeutic Biologics Mix Activity That Suggests the Potential for Clinical Benefits of COVID-19 Patients.
• Actual Study Start Date: October 20, 2021
• Estimated Primary Completion Date: March 28, 2022
• Estimated Study Completion Date: March 28, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Assess for COVID-19 Antigen Presentation Therapeutic Biologics Mix activity; CoronaVac® Organism 1.0 mL; TICE® BCG Organism 50 MG	Biological: CoronaVac® plus TICE® BCG Mix for Intradermal Injection; Intradermic Injection, ID; CoronaVac® Organism 1.0 mL plus TICE® BCG Organism 50 MG Mix; Other Name: CoronaVac® Organism plus TICE® BCG Organism Mix

Outcome Measures

Primary Outcome Measures :

1. Negative testing COVID-19 by standard RT-PCR assay [ Time Frame: Duration at least 28 days ]
   Negative testing COVID-19 by standard RT-PCR assay after injection 2 weeks

Eligibility Criteria

• Ages Eligible for Study: 24 Years to 74 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

• Conducting an initial, small, controlled clinical trial to assess for COVID-19 Antigen Presentation Therapeutic Biologics Mix that suggests the potential for clinical benefit of COVID-19 patients.
• 20 Lower Than Mild COVID-19 Patients

Inclusion Criteria:

• Lower Than Mild COVID-19 Patients
• Positive testing COVID-19 by standard RT-PCR assay
• COVID-19 infection without symptoms
• Symptoms of mild illness with COVID-19 that could include fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, and loss of taste or smell, without shortness of breath or dyspnea
• No clinical signs indicative of Moderate, Severe, or Critical Severity
• PPD negative participant is 10 TU skin test reading < 5 mm induration at 48 hours.

Exclusion Criteria:

• PPD positive participant is 10 TU skin test reading > 5 mm induration at 48 hours
• 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
• Symptoms suggestive of severe systemic illness with COVID-19, which could include any symptom of moderate illness or shortness of breath at rest, or respiratory distress
• Clinical signs indicative of severe systemic illness with COVID-19
• Evidence of critical illness
• Respiratory failure
• Shock
• Multi-organ dysfunction / failure

Contacts and Locations

Locations

United States, Maryland

MIDI Clinical Trial Sites -c/o- Dr. Han Xu - Sponsor / Investigators / Physicians / Laboratories Operation Site

Rockville, Maryland, United States, 20853

Sponsors and Collaborators

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

Investigators

• Study Chair: HAN XU, MD/PhD/FAPCR; IRB00009424
• Study Director: HAN XU, MD/PhD/FAPCR; IORG0007849
• Principal Investigator: HAN XU, MD/PhD/FAPCR; IORG0007849-FWA00015357

  Study Documents (Full-Text)

Documents provided by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair, Medicine Invention Design, Inc:

Study Protocol  [PDF] January 11, 2022

Informed Consent Form  [PDF] January 11, 2022

More Information

Additional Information:

FWA00015357 

IRB00009424 

IORG0007849 

Publications:

O'Neill LAJ, Netea MG. BCG-induced trained immunity: can it offer protection against COVID-19? Nat Rev Immunol. 2020 Jun;20(6):335-337. doi: 10.1038/s41577-020-0337-y. Review.

Covián C, Retamal-Díaz A, Bueno SM, Kalergis AM. Could BCG Vaccination Induce Protective Trained Immunity for SARS-CoV-2? Front Immunol. 2020 May 8;11:970. doi: 10.3389/fimmu.2020.00970. eCollection 2020.

Zhang Y, Zeng G, Pan H, Li C, Hu Y, Chu K, Han W, Chen Z, Tang R, Yin W, Chen X, Hu Y, Liu X, Jiang C, Li J, Yang M, Song Y, Wang X, Gao Q, Zhu F. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021 Feb;21(2):181-192. doi: 10.1016/S1473-3099(20)30843-4. Epub 2020 Nov 17.

Wu Z, Hu Y, Xu M, Chen Z, Yang W, Jiang Z, Li M, Jin H, Cui G, Chen P, Wang L, Zhao G, Ding Y, Zhao Y, Yin W. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021 Jun;21(6):803-812. doi: 10.1016/S1473-3099(20)30987-7. Epub 2021 Feb 3.

Han B, Song Y, Li C, Yang W, Ma Q, Jiang Z, Li M, Lian X, Jiao W, Wang L, Shu Q, Wu Z, Zhao Y, Li Q, Gao Q. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy children and adolescents: a double-blind, randomised, controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021 Dec;21(12):1645-1653. doi: 10.1016/S1473-3099(21)00319-4. Epub 2021 Jun 28.

Medeiros-Ribeiro AC, Aikawa NE, Saad CGS, Yuki EFN, Pedrosa T, Fusco SRG, Rojo PT, Pereira RMR, Shinjo SK, Andrade DCO, Sampaio-Barros PD, Ribeiro CT, Deveza GBH, Martins VAO, Silva CA, Lopes MH, Duarte AJS, Antonangelo L, Sabino EC, Kallas EG, Pasoto SG, Bonfa E. Immunogenicity and safety of the CoronaVac inactivated vaccine in patients with autoimmune rheumatic diseases: a phase 4 trial. Nat Med. 2021 Oct;27(10):1744-1751. doi: 10.1038/s41591-021-01469-5. Epub 2021 Jul 30.

Akova M, Unal S. A randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of SARS-CoV-2 vaccine (inactivated, Vero cell): a structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Apr 13;22(1):276. doi: 10.1186/s13063-021-05180-1.

• Responsible Party: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair, M.D., Ph.D., FAPCR, Sponsor-Investigator, IORG Director, Medical Monitor, Safety Officer, IRB Chair, Medicine Invention Design, Inc
• ClinicalTrials.gov Identifier: NCT03348670
• Other Study ID Numbers: IND158083; FWA00015357 ( Registry Identifier: DHHS-OHRP-FWA ); IRB00009424 ( Registry Identifier: DHHS-OHRP-IRB ); IORG0007849 ( Registry Identifier: DHHS-OHRP-IORG ); IND158083 ( Registry Identifier: FDA-IND ); NDA216636 ( Registry Identifier: FDA-NDA ); BLA761273 ( Registry Identifier: FDA-BLA )
• First Posted: November 21, 2017
• Last Update Posted: January 14, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair, Medicine Invention Design, Inc:

Escape Mutation; ADE; Antigen Presentation; APC; Trained Immunity; Spike; innate immune memory

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; BCG Vaccine; Adjuvants, Immunologic; Immunologic Factors; Physiological Effects of Drugs