Discovery Stage COVID-19 Antigen Presentation Therapeutic Biologics Mix to Treat COVID-19 Virus Infection (ApTpBioMix)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03348670|
Recruitment Status : Active, not recruiting
First Posted : November 21, 2017
Last Update Posted : January 14, 2022
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.
- Treat Infection of Multiple Gene Mutation COVID-19 Virus Strains.
- Activate human COVID-19 Antigen Presentation Reaction.
- 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|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
|Masking:||None (Open Label)|
|Masking Description:||Open Label|
|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|
Experimental: Assess for COVID-19 Antigen Presentation Therapeutic Biologics Mix activity
Biological: CoronaVac® plus TICE® BCG Mix for Intradermal Injection
Other Name: CoronaVac® Organism plus TICE® BCG Organism Mix
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348670
|United States, Maryland|
|MIDI Clinical Trial Sites -c/o- Dr. Han Xu - Sponsor / Investigators / Physicians / Laboratories Operation Site|
|Rockville, Maryland, United States, 20853|
|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|