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Site-Specific Immunomodulator

QBKPN for Respiratory Infections (RESILIENCE Trial)

Phase 2
Waitlist Available
Led By Theodore Steiner, MD FRCPC
Research Sponsored by Qu Biologics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be aged 65 years or older
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to weeks 8,16, 26, 34, 42 & 52
Awards & highlights

RESILIENCE Trial Summary

This trial will help determine if QBKPN is effective in improving immune function in older adults.

Who is the study for?
This trial is for older adults (65+) living in certain care facilities who can consent to the study. They must not be on strong immune-suppressing drugs, have a life expectancy less than 3 months, or be treated recently with antibiotics/antivirals. Men must use contraception if applicable.Check my eligibility
What is being tested?
The trial tests QBKPN SSI, an immunomodulator aiming to boost innate immunity and protect against respiratory infections in older adults. It's compared with a saline placebo to see if it also enhances responses to COVID-19 vaccines and overall health.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions similar to other immune system modulators such as injection site reactions, flu-like symptoms, fatigue, or allergic responses.

RESILIENCE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 65 years old or older.

RESILIENCE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to weeks 8,16, 26, 34, 42 & 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to weeks 8,16, 26, 34, 42 & 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cell physiology
Change in clinical laboratory parameters (safety & tolerability) measured by blood chemistry analysis in participants treated with QBKPN SSI compared to placebo
Change in clinical laboratory parameters (safety & tolerability) measured by blood hematology analysis in participants treated with QBKPN SSI compared to placebo
+2 more
Secondary outcome measures
Change in all-cause mortality in participants treated with QBKPN SSI compared to placebo
Change in end-of-life prediction score as measured by Changes in Health, End-Stage Disease and Signs and Symptoms (CHESS) scale in participants treated with QBKPN SSI compared to placebo
Change in frailty as measured by the Rockwood Clinical Frailty Scale in participants treated with QBKPN SSI compared to placebo
+21 more
Other outcome measures
Assessment of correlation of Immunoglobulin G (IgG) antibodies to K.variicola with the NK cell function and innate immune training in participants treated with QBKPN SSI compared to placebo
Assessment of glycemic control through hemoglobin A1C (HbA1c) in participants treated with QBKPN compared to placebo
Change in additional measures of plasma immune biomarkers that regulate innate & adaptive immune function augmentation measured using TruCulture Tube® assay (under stimulated & unstimulated conditions) of 48 analytes (cytokines & chemokines)
+5 more

RESILIENCE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: QBKPN SSIExperimental Treatment1 Intervention
QBKPN SSI (0.1 mL) by subcutaneous injection 3 times per week (Monday, Wednesday & Friday) for 16 weeks
Group II: PlaceboPlacebo Group1 Intervention
Placebo (Normal Saline) (0.1 mL) by subcutaneous injection 3 times per week (Monday, Wednesday & Friday) for 16 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
QBKPN SSI
2014
Completed Phase 2
~10

Find a Location

Who is running the clinical trial?

Qu Biologics Inc.Lead Sponsor
5 Previous Clinical Trials
105 Total Patients Enrolled
The National Research Council of Canada Industrial Research Assistance ProgramUNKNOWN
Theodore Steiner, MD FRCPCPrincipal InvestigatorUniversity of British Columbia

Media Library

QBKPN SSI (Site-Specific Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT05421325 — Phase 2
Immune Deficiency Research Study Groups: QBKPN SSI, Placebo
Immune Deficiency Clinical Trial 2023: QBKPN SSI Highlights & Side Effects. Trial Name: NCT05421325 — Phase 2
QBKPN SSI (Site-Specific Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05421325 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research team accepting new volunteers for this experiment?

"The evidence on clinicaltrials.gov reveals that this particular medical trial is not actively recruiting anymore and has been dormant since June 13th, 2022; the initial post date was September 1st of the same year. However, 169 other studies are currently in need of participants."

Answered by AI

Has the FDA sanctioned QBKPN SSI for medical use?

"Our team at Power assigned QBKPN SSI a safety ranking of 2, as it is currently undergoing Phase 2 trials and there are only preliminary results supporting its safety profile."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Assessment of QBKPN Site-Specific Immunomodulator Efficacy in Improving Innate Immune Function & Reducing Respiratory Tract Infection Morbidity in Older Adults
2023. "Assessment of QBKPN Site-Specific Immunomodulator Efficacy in Improving Innate Immune Function & Reducing Respiratory Tract Infection Morbidity in Older Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05421325.
~18 spots leftby Sep 2024
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