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

Study Overview
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Brief Summary
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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. Treat Infection of Multiple Gene Mutation COVID-19 Virus Strains. Activate Human Antigen Presentation Reaction to COVID-19 Specific Antigen. 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
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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.

Official Title
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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.

Conditions
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Covid19

Intervention / Treatment
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* Biological: COVID-19 Therapeutic Biologics - Spike-GM-CSF Protein Lactated Ringer's Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single Usage / Single Dosage
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Assess for therapeutic biologics activity (proof-of-concept)<br>0.1mg Spike-GM-CSF Protein 0.5 ml Lactated Ringer's Injection, USP | Biological: COVID-19 Therapeutic Biologics - Spike-GM-CSF Protein Lactated Ringer's Injection<br>* Intradermic Injection, ID COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection<br>* Other names: COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spike, Gene Mutation, Antigen Presentation, APC, COVID-19