Status:
ACTIVE_NOT_RECRUITING
Proof-of-Concept Clinical Pharmacology Trial for COVID-19 Antigen Presentation Therapeutic Biologic Mix
Lead Sponsor:
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Collaborating Sponsors:
UnitedHealthcare
Conditions:
Covid19
Eligibility:
All Genders
24-64 years
Phase:
EARLY_PHASE1
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 patient...
Detailed Description
* Conducting an initial small, controlled trial to assess therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of COVID-19 patients with controlled cancer...
Eligibility Criteria
Inclusion
- Conducting an initial small, controlled trial to assess therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of COVID-19 patients with controlled cancers.
- 20 Moderate COVID-19 patients with controlled cancers
- Controlled Cancers
- 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
- 1\. Uncontrolled Cancers
- 2\. Severe or Critical Illness Severity
- 3\. Pregnancy
- 4\. Breast-feeding
- 5\. The patients with other serious inter-current illness
- 6\. Serious Allergy
- 7\. Serious Bleed Tendency
- 8\. The prohibition of the biological product
Key Trial Info
Start Date :
May 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 28 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03305341
Start Date
May 18 2025
End Date
July 28 2026
Last Update
June 11 2025
Active Locations (1)
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1
Medicine Invention Design Incorporation (MIDI) - IORG0007849
North Bethesda, Maryland, United States, 20852