Conducting an initial small, controlled clinical pharmacology trial to assess fortherapeutic biologics activity (proof-of-concept) that suggests the potential forclinical 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.
- 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.
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 Name: COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection
- 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
Medicine Invention Design Incorporation (MIDI) - IORG0007849
North Bethesda, Maryland, United States