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 with controlled cancers.
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.
Who can participate
Age range
24 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Early Phase 1 and is no longer actively enrolling — what does that mean for my ability to access any treatments being studied here, and could the early-phase status mean there are still unknowns about safety that I should weigh carefully?
2The trial is measuring immune responses using something called an IGRA blood test with COVID-19 spike protein and TB antigens — can you explain what that test is looking for and what it would mean for my situation if my results came back positive or negative?
3Since the trial is tracking both moderate COVID-19 cases and nucleic acid test results, does that suggest I would need to have an active or recent COVID-19 infection to be relevant for this kind of approach, and how does that compare to standard treatments available to me right now?
4The trial involves a 'therapeutic biologic mix' described as an antigen presentation therapy — could you help me understand how that differs from a vaccine or standard antiviral treatment, and what is actually known at this stage about whether it works?
5Given that this trial is no longer recruiting, are there similar early-phase studies or emerging therapies targeting the immune response to COVID-19 that might be worth exploring as an alternative path to discuss with you?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Moderate COVID-19:
Timeframe: Duration at least 28 days
2
Rate of Positive COVID-19 nucleic acid:
Timeframe: Duration at least 28 days
3
Rate of Negative COVID-19 nucleic acid
Timeframe: Duration at least 28 days
4
20 COVID-19 Participants with IGRA blood test with COVID-19 spike protein antigen
Timeframe: Duration at least 28 days
5
20 COVID-19 Participants with IGRA blood test with TB antigens