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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 28, 2020
Sponsor:
Information provided by (Responsible Party):
Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair, Medicine Invention Design, Inc

Brief Summary:

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.

  1. Treat Infection of Multiple Gene Mutation COVID-19 Virus Strains.
  2. Activate Antigen Presentation Reaction to COVID-19 Specific Antigen.
  3. Produce Antigen Presentation Memory to COVID-19 Specific Antigen.
  4. Produce Trained Immunity to COVID-19 Specific Antigen.
  5. 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

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
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 : October 28, 2020
Estimated Study Completion Date : November 28, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection




Primary Outcome Measures :
  1. Test Macrophage Migration Inhibitory Factor (MMIF) [ Time Frame: Duration at least 28 days ]
    Macrophage Migration Inhibitory Factor (MMIF), assessed by ELISA Sandwich Kit



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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

Information from the National Library of Medicine

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


Locations
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United States, Maryland
Medicine Invention Design, Inc. (MIDI) - c/o - MIDINC Clinical Investigator Working Site
North Bethesda, Maryland, United States, 20852
Sponsors and Collaborators
Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair
Investigators
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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
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair, M.D., Ph.D., Sponsor-Investigator, IORG Director, Medical Monitor, Safety Officer, IRB Chair, Medicine Invention Design, Inc
ClinicalTrials.gov Identifier: NCT03348670    
Other Study ID Numbers: BLA761214
FWA00015357 ( Registry Identifier: DHHS, OHRP )
IRB00009424 ( Registry Identifier: IRB )
IORG0007849 ( Registry Identifier: IORG )
IND153116 ( Registry Identifier: IND )
NDA215432 ( Registry Identifier: NDA )
BLA761214 ( Registry Identifier: BLA )
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair, Medicine Invention Design, Inc:
Escape Mutation
ADE
Antigen Presentation
APC
Trained Immunity
Spike
GM-CSF
innate immune memory
Additional relevant MeSH terms:
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Molgramostim
Sargramostim
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents