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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-03

Study Completion Date

2020-04-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Solid Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Nozin

Intervention Type DRUG

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

Arm II (standard of care)

Patients receive standard of care.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive standard of care

Interventions

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Nozin

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

Intervention Type DRUG

Best Practice

Receive standard of care

Intervention Type OTHER

Other Intervention Names

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Ethanol-based Intranasal Solution Ethanol-based Nasal Sanitizer Ethanol-containing Nasal Solution standard of care standard therapy

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No