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

Prevention of Respiratory Viruses Using Nozin in Stem Cell Transplant Recipients (PREV-NOSE Study)

This phase I trial studies the side effects of Nozin in preventing respiratory viral infections in patients undergoing stem cell transplant. Nozin is a non-antibiotic, alcohol-based nasal sanitizer used in hospitals to prevent spread of bacterial infections and may also prevent community acquired respiratory virus infection in stem cell transplant recipients.

Study Overview

• Status: Suspended
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm; Solid Neoplasm
• Intervention / Treatment: Other: Best Practice; Drug: Nozin

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Orland Park, Illinois, United States, 60462
      • University of Chicago Medicine-Orland Park
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Undergoing allogeneic hematopoietic transplant for malignant or non-malignant disease
• English speaking
• Capable of providing informed consent
• Planned to receive follow-up at the transplant site for the first 100 days post transplantation
• Subjects who the investigator believes can and will comply with the study protocol

Exclusion Criteria:

• Documented respiratory viral infection in the two weeks prior to enrollment
• Current or planned use of any prophylactic antiviral therapy, antibody treatments, or other agents targeting the prevention of respiratory viruses (i.e. oseltamivir, ribavirin, amantadine)
• Known allergy to study drug components (jojoba, orange oil, coconut oil, lauric acid, benzalkonium chloride, vitamin E)
• Receiving oxygen supplementation at time of enrollment
• Active mucositis at time of enrollment
• Ongoing irritation or active infection of the squamous epithelial cell skin involving the nose or nasal vestibule
• Daily use of nasal decontamination products or other nasal medications (e.g. nasal steroids)
• Unable to complete study procedures (e.g. nasal swab self-testing)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm II (standard of care); Patients receive standard of care.	Other: Best Practice; Receive standard of care; Other Names: standard of care; standard therapy
Experimental: Arm I (Nozin); 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 BID up to 100 days after transplant.	Drug: Nozin; Given via nasal single-use popswabs or single-use cotton tipped applicators; Other Names: Ethanol-based Intranasal Solution; Ethanol-based Nasal Sanitizer; Ethanol-containing Nasal Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability of Nozin	Will measure and describe reasons for dropout, defined as failure to complete the study to day 100 for any reason. Among participants in the study product arm, reasons for dropout will be classified as either directly related to the product or due to other reasons. Will estimate the proportion of participants who exit the study for reasons directly related to the study product with a precision of +/- 20% (95% confidence interval) to inform tolerability of study product for future studies. Will compare dropout for any reason between treatment arms using Fisher's exact test.	Up to 100 days post-transplant
Incidence of adverse events (AEs)	AEs will be graded in severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. All adverse events will be continually monitored by the study team and descriptively compared between study arms.	Up to 100 days post-transplant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of community acquired respiratory viruses (CARV)	Will compare the cumulative incidence of CARV between study arms, counting death as a competing risk. Cox regression will be used to test for differences in the cause-specific hazard of CARV between study arms.	Up to 100 days post-transplant
Frequency of respiratory viral symptoms	Will use Poisson generalized estimating equation regression models to compare the frequency of respiratory viral symptoms between study arms	Up to 100 days post-transplant
Number of respiratory viral panel tests	Will compare the number of respiratory viral panel tests sent to the lab between study arms using Poisson regression with an offset for the number of days each participant was in the study.	Up to 100 days post-transplant

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: Global Life Technologies Corp.
• Investigators: Principal Investigator: Steven Pergam, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2019
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: August 14, 2019
• First Submitted That Met QC Criteria: August 15, 2019
• First Posted (Actual): August 19, 2019

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Ethanol; Pharmaceutical Solutions
• Other Study ID Numbers: RG1004525; NCI-2019-05159 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 10087 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No