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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

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

ArmDescriptionAssigned Intervention
Experimental
Assess for therapeutic biologics activity (proof-of-concept) 		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
    Intradermic Injection, ID COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection
    Other names:
    • COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.