Assessment of QBKPN Site-Specific Immunomodulator Efficacy in Improving Innate Immune Function & Reducing Respiratory Tract Infection Morbidity in Older Adults — RESILIENCE  

Immune Deficiency Clinical Trial

Official title: Assessment of QBKPN Site-Specific Immunomodulator (SSI) Efficacy in Improving Innate Immune Function and Reducing All-Cause Respiratory Tract Infection Morbidity in Adults 65 Years of Age of Older Residing in Independent-Living, Assisted-Living and Long-term Care Facilities

Status Active, not recruiting

Clinical Trial Summary

This study is designed to test whether QBKPN SSI can improve immune function in older adults, including how well it can protect against respiratory and other infections, whether it improves the body's response to COVID-19 vaccines and what effect it has on maintaining or improving quality of life, activity level and health status.

QBKPN is a new medication in a class known as Site-Specific Immunomodulators (SSI). SSIs are designed to train and/or improve innate immune function to reduce the risk of infections, improve immune response to cancer, and slow the progression of chronic inflammatory diseases.

It is believed that QBKPN SSI can work with the immune system to help protect against respiratory and other infections.

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled study of adults 65 years of age or older residing in the community, in long-term care (LTC), independent-living or assisted-living facilities to assess the effect of QBKPN SSI on improvement of innate immunity and reduction of all-cause respiratory tract infection morbidity.

Approximately 72 participants will be enrolled; approximately 36 from the community and independent-living facilities and approximately 36 from assisted-living and LTC facilities.

Eligible participants will be screened and enrolled in the study by visiting study staff, who will conduct all study visits, administer study treatment and perform blood/sample collections. Participants will receive study treatment for 16 weeks then be monitored for 36 weeks post-study treatment with follow-up study visits and blood sampling performed.

Immunological testing for Natural Killer (NK) cell function, anti-viral innate immunity and trained innate immunity will be performed.

Safety and tolerability of study treatment will be measured with change in clinical laboratory parameters.

Clinical benefits of study treatment will be assessed via medical record review and patient-reported outcomes. Study staff will record any confirmed/probable/possible infections (viral and bacterial, including respiratory and non-respiratory), any microbiologic or radiologic testing performed to investigate for infection, any prescribed antibiotics/antivirals and duration of treatment and reason for and duration of any hospitalizations.

Clinical assessments will also include frailty index (Rockwood Clinical Frailty Scale), quality of life [Dementia Quality of Life Questionnaire(DEMQOL)] and end-of-life prediction score (CHESS Scale.) ;

Related Conditions & MeSH terms

• Immune Deficiency
• Immunologic Deficiency Syndromes
• Respiratory Tract Infections

• NCT number: NCT05421325
• Study type: Interventional
• Source: Qu Biologics Inc.
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 11, 2023
• Completion date: March 2025