Discovery Stage (Proof-of-concept) COVID-19 Antigen Presentation Therapeutic Biologics (COVID-19--AP) (AP-TP-Bio)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03348670|
Recruitment Status : Active, not recruiting
First Posted : November 21, 2017
Last Update Posted : September 1, 2021
Conducting an initial small, controlled clinical trial to assess for COVID-19 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 Antigen Presentation Reaction to COVID-19 Specific Antigen.
- Produce Antigen Presentation Memory to COVID-19 Specific Antigen.
- Produce Trained Immunity to COVID-19 Specific Antigen.
- Avoid Antibody-Dependent Enhancement (ADE) to COVID-19 Virus.
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Biological: COVID-19 Therapeutic Biologics - Spike-GM-CSF Protein Lactated Ringer's Injection||Early Phase 1|
- 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 Spike-GM-CSF Protein Lactated Ringer's Injection
- Intradermic Injection, ID
- After 60 hours
- Test Macrophage Migration Inhibitory Factor (MMIF)
- If Macrophage Migration Inhibitory Factor (MMIF) is positive (+)
- Successful trained immunity to COVID-19 specific antigen
- Negative testing COVID-19 by standard RT-PCR assay or equivalent testing after injection 2 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open Label|
|Official Title:||Conducting an Initial Small, Controlled Clinical Trial to Assess for COVID-19 Therapeutic Biologics Activity (Proof-of-concept) That Suggests the Potential for Clinical Benefits of COVID-19 Patients.|
|Actual Study Start Date :||July 20, 2020|
|Estimated Primary Completion Date :||June 28, 2022|
|Estimated Study Completion Date :||July 28, 2022|
Experimental: Assess for therapeutic biologics activity (proof-of-concept)
Biological: COVID-19 Therapeutic Biologics - Spike-GM-CSF Protein Lactated Ringer's Injection
Other Name: COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection
- Test Macrophage Migration Inhibitory Factor (MMIF) [ Time Frame: Duration at least 28 days ]Macrophage Migration Inhibitory Factor (MMIF), assessed by ELISA Sandwich Kit
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348670
|United States, Maryland|
|Medicine Invention Design, Inc. (MIDI) - c/o - MIDINC Clinical Investigator Working Site|
|North Bethesda, Maryland, United States, 20852|
|Study Chair:||HAN XU, M.D., Ph.D.||IRB00009424|
|Study Director:||HAN XU, M.D., Ph.D.||IORG0007849|
|Principal Investigator:||HAN XU, M.D., Ph.D.||MIDINC Clinical Research Multiple Group Unit|