Trial | NCT04060849  Report issue

Title

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)

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Recruiting

  • Intervention/Treatment

    Nozin ...

  • Study Participants

    50
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.
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 Started
Sep 03
2019
Primary Completion
Jul 31
2025
Anticipated
Study Completion
Jul 31
2025
Anticipated
Last Update
Dec 04
2023

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

Other Best Practice

Receive standard of care

  • Other names: standard of care, standard therapy

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.

Arm II (standard of care) Active Comparator

Patients receive standard of care.

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)
No Results Posted