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

Covid19 Clinical Trial

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.

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• COVID-19
• Covid19

• NCT number: NCT03305341
• Study type: Interventional
• Source: Medicine Invention Design, Inc
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: July 18, 2020
• Completion date: July 28, 2024