Ignite Creation Date:
2024-05-06 @ 10:36 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03305341
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-03-15
First Post:
2017-10-04
Brief Title:
Proof-of-Concept Clinical Pharmacology Trial for COVID-19 Antigen Presentation Therapeutic Biologics
Sponsor:
Han Xu MD PhD FAPCR Sponsor-Investigator IRB Chair
Organization:
Medicine Invention Design Inc
Study Overview
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
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COV19-APTP-B
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
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
01mg 05 ml COVID-19 Spike-GM-CSF Protein Lactated Ringers Injection
Intradermic Injection ID
Negative testing COVID-19 by standard RT-PCR assay or equivalent testing after injection 2 weeks
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
01mg 05 ml COVID-19 Spike-GM-CSF Protein Lactated Ringers Injection
Intradermic Injection ID
Negative testing COVID-19 by standard RT-PCR assay or equivalent testing after injection 2 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FWA00015357 | REGISTRY | None | None |
| IRB00009424 | REGISTRY | None | None |
| IORG0007849 | REGISTRY | None | None |
| IND153210 | REGISTRY | None | None |
| NDA215451 | REGISTRY | None | None |
| BLA761218 | REGISTRY | BLA PDP FDA | None |