Proof-of-Concept Clinical Pharmacology Trial for COVID-19 Antigen Presentation Therapeutic Biologics
Purpose
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.
Condition
- Covid19
Eligibility
- Eligible Ages
- Between 22 Years and 72 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Single Usage / Single Dosage
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
- Masking Description
- Open Label
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Assess for therapeutic biologics activity (proof-of-concept) |
0.1mg Spike-GM-CSF Protein 0.5 ml Lactated Ringer's Injection, USP |
|
Recruiting Locations
More Details
- NCT ID
- NCT03305341
- Status
- Active, not recruiting
- Sponsor
- Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Detailed 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.