Hematopoietic and Lymphoid Cell NeoplasmPhase 1NCT04060849
Nozin in Preventing Respiratory Viral Infections in Patients Undergoing Stem Cell Transplant, PREV-NOSE STUDY
A Phase 1 study testing Nozin and Best Practice in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by Fred Hutchinson Cancer Center at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Solid Neoplasm
- What is being tested?
- Nozin and Best Practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Sep 2019to 12 Apr 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Prevention of Respiratory Viruses Using Nozin in Stem Cell Transplant Recipients (PREV-NOSE Study)
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.
Read the 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.
- Being tested
- Nozin, Best Practice
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NozinDrug
Also called Ethanol-based Intranasal Solution, Ethanol-based Nasal Sanitizer, Ethanol-containing Nasal Solution
Given via nasal single-use popswabs or single-use cotton tipped applicators
Best PracticeOther
Also called standard of care, standard therapy
Receive standard of care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Nozin |
| Arm II (standard of care) | Active comparator | Patients receive standard of care. Receives: Other: Best Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 100 days post-transplant
Secondary outcomes (3)
Incidence of community acquired respiratory viruses (CARV)
Will compare the cumulative incidence of CARV between study arms, counting death as a competing risk. Cox regression will be used to test for differences in the cause-specific hazard of CARV between study arms.
Measured: Up to 100 days post-transplant
Frequency of respiratory viral symptoms
Will use Poisson generalized estimating equation regression models to compare the frequency of respiratory viral symptoms between study arms
Measured: Up to 100 days post-transplant
Number of respiratory viral panel tests
Will compare the number of respiratory viral panel tests sent to the lab between study arms using Poisson regression with an offset for the number of days each participant was in the study.
Measured: Up to 100 days post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start3 Sep 2019
- Primary completion12 Apr 2020
- Study completion12 Apr 2020
Why it stopped: The study was closed to accrual according to the Fred Hutch/University of Washington/Seattle Children's Consortium low accrual institutional policy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Global Life Technologies Corp.
- Responsible party
- Sponsor
- Investigators
- Steven Pergam, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060849
- Sponsor's protocol ID
- RG1004525
- Other IDs
- NCI-2019-05159, 10087
- Status last verified
- Nov 2024
- First submitted
- 14 Aug 2019
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Respiratory Viruses Using Nozin in Stem Cell Transplant Recipients (PREV-NOSE Study)
- ClinicalTrials.gov ID
- NCT04060849
- Acronym / sponsor ID
- RG1004525
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was closed to accrual according to the Fred Hutch/University of Washington/Seattle Children's Consortium low accrual institutional policy.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- Global Life Technologies Corp.
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 12 Apr 2020 (actual)
- Study completion
- 12 Apr 2020 (actual)
- First posted
- 19 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Nozin) | Experimental | Drug: NozinBeginning 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 | Other: Best PracticePatients receive standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NozinAlso: Ethanol-based Intranasal Solution, Ethanol-based Nasal Sanitizer, Ethanol-containing Nasal SolutionGiven via nasal single-use popswabs or single-use cotton tipped applicators | Drug | Arm I (Nozin) |
| Best PracticeAlso: standard of care, standard therapyReceive standard of care | Other | Arm II (standard of care) |
Primary outcome
Tolerability of Nozin
Time frame: Up to 100 days post-transplant
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.
Incidence of adverse events (AEs)
Time frame: Up to 100 days post-transplant
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.
3 secondary outcomes
Incidence of community acquired respiratory viruses (CARV)
Time frame: Up to 100 days post-transplant
Frequency of respiratory viral symptoms
Time frame: Up to 100 days post-transplant
Number of respiratory viral panel tests
Time frame: Up to 100 days post-transplant
Results and safety
The study was stopped early (reason given: The study was closed to accrual according to the Fred Hutch/University of Washington/Seattle Children's Consortium low accrual institutional policy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Pergam principal investigator
Fred Hutch/University of Washington Cancer Consortium
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nozin and Best Practice in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by Fred Hutchinson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was closed to accrual according to the Fred Hutch/University of Washington/Seattle Children's Consortium low accrual institutional policy.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability of Nozin (time frame: Up to 100 days post-transplant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.