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

Early Phase 1

Active, not recruiting

• Conditions: Covid19
• Interventions: Biological: COVID-19 Therapeutic Biologics - Spike-GM-CSF Protein Lactated Ringer's Injection

• Registration Number: NCT03305341
• Lead Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

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.

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.

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 Timeline

• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-10-04
• Study First Posted: 2017-10-09
• Study Start: 2020-07-18
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-15
• Primary Completion: 2024-07-28
• Study Completion: 2024-07-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Assess for therapeutic biologics activity (proof-of-concept)	COVID-19 Therapeutic Biologics - Spike-GM-CSF Protein Lactated Ringer's Injection	* 0.1mg Spike-GM-CSF Protein * 0.5 ml Lactated Ringer's Injection, USP

Primary Outcome Measures

Name	Time	Method
Rate of Positive COVID-19 nucleic acid:	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%
Concentration of Active Ingredient:	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
Rate of Negative COVID-19 nucleic acid	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%
Number of Participants with Moderate COVID-19:	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

Trial Locations

Locations (1)

Medicine Invention Design Incorporation (MIDI) - IORG0007849; 🇺🇸 North Bethesda, Maryland, United States