Covid19
Conditions
Keywords
Gene Mutation, Antigen Presentation, APC, Spike, COVID-19
Brief 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 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.
Detailed description
* 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.
Interventions
BIOLOGICALCOVID-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
Sponsors
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
UnitedHealthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
Open Label
Intervention model description
Single Usage / Single Dosage
Eligibility
Sex/Gender
ALL
Age
24 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Moderate COVID-19: | Duration at least 28 days | * 20 Moderate COVID-19 patients with controlled cancers * 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 |
| Rate of Positive COVID-19 nucleic acid: | Duration at least 28 days | * 20 Moderate COVID-19 patients with controled cancers * 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% |
| Rate of Negative COVID-19 nucleic acid | Duration at least 28 days | * 20 Moderate COVID-19 patients with controlled cancers * NOVAVAX COVID-19 VACCINE 1.0 mL plus BCG Organism 50 MG Mix * By the percutaneous route with the multiple puncture device * Negative COVID-19 by standard RT-PCR assay after percutaneous use 3 weeks * COVID-19 nucleic acid testing, assessed by RT-PCR Assay Kit * Rate of Negative COVID-19 nucleic acid will be more than 80% |
| 20 COVID-19 Participants with IGRA blood test with COVID-19 spike protein antigen | Duration at least 28 days | Positive IGRA blood test with COVID-19 spike protein antigen after percutaneous use 21 days |
| 20 COVID-19 Participants with IGRA blood test with TB antigens | Duration at least 28 days | * Negative IGRA blood test with TB antigens before percutaneous use * Positive IGRA blood test with TB antigens after percutaneous use 21 days |
Countries
United States
Contacts
STUDY_CHAIRHAN XU, MD/PhD/FAPCR
Medicine Invention Design, Inc. (MIDI) - IORG0007849
STUDY_DIRECTORHAN XU, MD/PhD/FAPCR
Medicine Invention Design, Inc. (MIDI) - IORG0007849
PRINCIPAL_INVESTIGATORHAN XU, MD/PhD/FAPCR
Medicine Invention Design, Inc. (MIDI) - IORG0007849
Outcome results
None listed