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

Fred Hutchinson Cancer Center (FHCC)

Status and phase: Terminated; Phase 1

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

Treatments: Other: Best Practice; Drug: Nozin

Study type: Interventional

Funder types: Other

Identifiers

NCT04060849

RG1004525

NCI-2019-05159 (Registry Identifier)

10087 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

10 participants in 2 patient groups

Arm I (Nozin)

Experimental group

Description:

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.

Treatment:

Drug: Nozin

Arm II (standard of care)

Active Comparator group

Description:

Patients receive standard of care.

Treatment:

Other: Best Practice