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

March 13, 2023 updated by: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • North Bethesda, Maryland, United States, 20852
        • Medicine Invention Design Incorporation (MIDI) - IORG0007849

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 72 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Moderate COVID-19:
Time Frame: Duration at least 28 days
  • 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
Duration at least 28 days
Rate of Positive COVID-19 nucleic acid:
Time Frame: Duration at least 28 days
  • 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%
Duration at least 28 days
Concentration of Active Ingredient:
Time Frame: Duration at least 28 days
  • 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
Duration at least 28 days
Rate of Negative COVID-19 nucleic acid
Time Frame: Duration at least 28 days
  • 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%
Duration at least 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

Collaborators

PPD

Investigators

  • Principal Investigator: HAN XU, M.D., Ph.D., Medicine Invention Design, Inc. (MIDI) - IORG0007849
  • Study Director: HAN XU, M.D., Ph.D., Medicine Invention Design, Inc. (MIDI) - IORG0007849
  • Study Chair: HAN XU, M.D., Ph.D., Medicine Invention Design, Inc. (MIDI) - IORG0007849

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2020

Primary Completion (Anticipated)

July 28, 2024

Study Completion (Anticipated)

July 28, 2024

Study Registration Dates

First Submitted

October 4, 2017

First Submitted That Met QC Criteria

October 4, 2017

First Posted (Actual)

October 9, 2017

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IND153210 (Registry Identifier: IND PDP FDA)
  • FWA00015357 (Registry Identifier: HHS, Human Protections Administrator)
  • IORG0007849 (Registry Identifier: HHS, IORG)
  • IRB00009424 (Registry Identifier: HHS, IRB)
  • NDA215451 (Registry Identifier: NDA PDP FDA)
  • BLA761218 (Registry Identifier: BLA PDP FDA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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