Nozin in Preventing Respiratory Viral Infections in Patients Undergoing Stem Cell Transplant, PREV-NOSE STUDY

PRIMARY OBJECTIVE:

I. To evaluate the tolerability of a non-antibiotic, alcohol-based nasal antiseptic in a cohort of hematopoietic stem cell transplant (HCT) recipients during the peri and post-transplant period (100 days after transplantation).

SECONDARY OBJECTIVES:

I. To assess the efficacy of a non-antibiotic, alcohol-based nasal antiseptic versus (vs.) control for community acquired respiratory virus (CARV) prevention during the early pre-transplant and post-transplant periods (100 days).

II. To compare the frequency of respiratory viral symptoms in subjects on study product vs. control.

III. To compare the overall number of respiratory viral panel tests sent among subjects using product vs. control.

TERTIARY/EXPLORATORY OBJECTIVES:

I. To compare number of lower respiratory tract viral infections among those on study product vs. control.

II. To compare total number of days in droplet isolation between those on study product vs. control.

III. To compute the frequency of missed applications of study product (overall adherence among participants in the study product arm).

IV. To compute the frequency of adverse effects of the study product among subjects on the study product arm.

V. To compare the frequency of adverse events between those on study product vs. control.

VI. To compare total number of outpatient days between those on study product vs. control.

VII. To compare microbiome changes among subjects on study product vs. control.

VIII. To compare the cycle time/viral loads of subjects with documented respiratory viruses on study product vs. control.

IX. To compare the length of viral shedding in subjects with documented respiratory viruses on study product vs. control.

X. To compare catheter-related bloodstream infections in subjects on study product vs. control.

XI. To compare the number of bacterial/fungal respiratory infections among subjects using product vs. control.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Beginning 7 days prior to transplant, patients receive Nozin via nasal single-use popswabs or single-use cotton tipped applicators and swab the inside of their nose two times daily (BID) up to 100 days after transplant.

ARM II: Patients receive standard of care.

After completion of study, patients are followed up every week for 6 weeks and then every alternate week until day 100.