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Proof-of-Concept Clinical Pharmacology Trial for COVID-19 Antigen Presentation Therapeutic Biologics (COV19-APTP-B)

Primary Purpose

Covid19

Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
COVID-19 Therapeutic Biologics - Spike-GM-CSF Protein Lactated Ringer's Injection
Sponsored by
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Gene Mutation, Antigen Presentation, APC, Spike, COVID-19

Eligibility Criteria

22 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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

Sites / Locations

  • Medicine Invention Design Incorporation (MIDI) - IORG0007849

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Assess for therapeutic biologics activity (proof-of-concept)

Arm Description

0.1mg Spike-GM-CSF Protein 0.5 ml Lactated Ringer's Injection, USP

Outcomes

Primary Outcome Measures

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
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%
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
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%

Secondary Outcome Measures

Full Information

First Posted
October 4, 2017
Last Updated
March 13, 2023
Sponsor
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Collaborators
PPD
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1. Study Identification

Unique Protocol Identification Number
NCT03305341
Brief Title
Proof-of-Concept Clinical Pharmacology Trial for COVID-19 Antigen Presentation Therapeutic Biologics
Acronym
COV19-APTP-B
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 18, 2020 (Actual)
Primary Completion Date
July 28, 2024 (Anticipated)
Study Completion Date
July 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Collaborators
PPD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Gene Mutation, Antigen Presentation, APC, Spike, COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Single Usage / Single Dosage
Masking
None (Open Label)
Masking Description
Open Label
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Assess for therapeutic biologics activity (proof-of-concept)
Arm Type
Experimental
Arm Description
0.1mg Spike-GM-CSF Protein 0.5 ml Lactated Ringer's Injection, USP
Intervention Type
Biological
Intervention Name(s)
COVID-19 Therapeutic Biologics - Spike-GM-CSF Protein Lactated Ringer's Injection
Other Intervention Name(s)
COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection
Intervention Description
Intradermic Injection, ID COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection
Primary Outcome Measure Information:
Title
Number of Participants with Moderate COVID-19:
Description
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
Time Frame
Duration at least 28 days
Title
Rate of Positive COVID-19 nucleic acid:
Description
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%
Time Frame
Duration at least 28 days
Title
Concentration of Active Ingredient:
Description
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
Time Frame
Duration at least 28 days
Title
Rate of Negative COVID-19 nucleic acid
Description
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%
Time Frame
Duration at least 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HAN XU, M.D., Ph.D.
Organizational Affiliation
Medicine Invention Design, Inc. (MIDI) - IORG0007849
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
HAN XU, M.D., Ph.D.
Organizational Affiliation
Medicine Invention Design, Inc. (MIDI) - IORG0007849
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
HAN XU, M.D., Ph.D.
Organizational Affiliation
Medicine Invention Design, Inc. (MIDI) - IORG0007849
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medicine Invention Design Incorporation (MIDI) - IORG0007849
City
North Bethesda
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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27102489
Citation
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Links:
URL
http://ohrp.cit.nih.gov/search
Description
FWA00015357
URL
http://ohrp.cit.nih.gov/search
Description
IRB00009424
URL
http://ohrp.cit.nih.gov/search
Description
IORG0007849

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

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