Nozin in Preventing Respiratory Viral Infections in Patients Undergoing Stem Cell Transplant, PREV-NOSE STUDY
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|ClinicalTrials.gov Identifier: NCT04060849|
Recruitment Status : Recruiting
First Posted : August 19, 2019
Last Update Posted : October 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Viral Upper Respiratory Tract Infection Allogeneic Bone Marrow Transplantation Recipient||Drug: Nozin Other: Best Practice||Phase 1|
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 three times daily (TID) 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevention of Respiratory Viruses Using Nozin in Stem Cell Transplant Recipients (PREV-NOSE Study)|
|Actual Study Start Date :||September 3, 2019|
|Estimated Primary Completion Date :||August 1, 2021|
|Estimated Study Completion Date :||August 1, 2021|
Experimental: 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 TID up to 100 days after transplant.
Given via nasal single-use popswabs or single-use cotton tipped applicators
Active Comparator: Arm II (standard of care)
Patients receive standard of care.
Other: Best Practice
Receive standard of care
- 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.
- Incidence of community acquired respiratory viruses (CARV) [ Time Frame: Up to 100 days post-transplant ]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.
- Frequency of respiratory viral symptoms [ Time Frame: Up to 100 days post-transplant ]Will use Poisson generalized estimating equation regression models to compare the frequency of respiratory viral symptoms between study arms
- Number of respiratory viral panel tests [ Time Frame: Up to 100 days post-transplant ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04060849
|Contact: Sara Marquisemail@example.com|
|United States, Illinois|
|University of Chicago Medicine-Orland Park||Not yet recruiting|
|Orland Park, Illinois, United States, 60462|
|Contact: Kathleen Mullane 773-702-6119 firstname.lastname@example.org|
|Principal Investigator: Kathleen Mullane|
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Sara Marquis 206-667-2100 email@example.com|
|Principal Investigator: Steven Pergam|
|Principal Investigator:||Steven Pergam||Fred Hutch/University of Washington Cancer Consortium|