Clinical trial NCT04060849: Nozin in Preventing Respiratory Viral Infections in Patients Undergoing Stem Cell Transplant, PREV-NOSE STUDY
Official title: Prevention of Respiratory Viruses Using Nozin in Stem Cell Transplant Recipients (PREV-NOSE Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Solid Neoplasm
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: Global Life Technologies Corp.
First posted: 2019-08-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Tolerability of Nozin
timeFrame: Up to 100 days post-transplant
measure: Incidence of adverse events (AEs)
timeFrame: Up to 100 days post-transplant
Secondary outcomes:
measure: Incidence of community acquired respiratory viruses (CARV)
timeFrame: Up to 100 days post-transplant
measure: Frequency of respiratory viral symptoms
timeFrame: Up to 100 days post-transplant
measure: Number of respiratory viral panel tests
timeFrame: Up to 100 days post-transplant
Other outcomes:
Locations:
city: Orland Park
country: United States
facility: University of Chicago Medicine-Orland Park
state: Illinois
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Steven Pergam
role: PRINCIPAL_INVESTIGATOR
References: