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

NCT04060849 | Terminated Phase 1 DMC FDA Drug

• 3 other identifiers: RG1004525NCI-2019-0515910087
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm; Solid Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Incidence of community acquired respiratory viruses (CARV)

  Up to 100 days post-transplant

• Frequency of respiratory viral symptoms

  Up to 100 days post-transplant

• Number of respiratory viral panel tests

  Up to 100 days post-transplant

Study Arms (2)

Arm I (Nozin)

EXPERIMENTAL

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

Arm II (standard of care)

ACTIVE COMPARATOR

Patients receive standard of care.

Other: Best Practice

Interventions

Nozin DRUG

Given via nasal single-use popswabs or single-use cotton tipped applicators

Also known as: Ethanol-based Intranasal Solution, Ethanol-based Nasal Sanitizer, Ethanol-containing Nasal Solution

Arm I (Nozin)

Best Practice OTHER

Receive standard of care

Also known as: standard of care, standard therapy

Arm II (standard of care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• Global Life Technologies Corp.: collaborator

Study Sites (2)

University of Chicago Medicine-Orland Park

Orland Park, Illinois, 60462, United States

Location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Steven Pergam

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 19, 2019
• Study Start: September 3, 2019
• Primary Completion: April 12, 2020
• Study Completion: April 12, 2020
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)