Clinical Assessment of Insulin Fast Dissolving Film in Treatment of Post Infection Anosmia
"Insulin Fast Dissolving Film for Intranasal Delivery Via Olfactory Region, a Promising Approach for the Treatment of Anosmia in COVID 19 Patients: Design, In-vitro Characterization and Clinical Evaluation."
1 other identifier
interventional
40
1 country
1
Brief Summary
The study aimed to investigate the efficacy of insulin in a new dosage form ( fast dissolving film) in treatment of anosmia in patients post infested with Covid-19. The study implication based in two methods evaluations
- 1.Threshold test
- 2.identification test.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2020
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2020
CompletedFirst Submitted
Initial submission to the registry
December 2, 2020
CompletedFirst Posted
Study publicly available on registry
December 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2021
CompletedOctober 26, 2021
October 1, 2021
5 months
December 2, 2020
October 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Smell sensation improvement
By decrease the threshold sensation with butanol test
4 weeks
Study Arms (2)
Insulin fast dissolving film
EXPERIMENTALFormulated bioadhesive fast dissolving film contains 100IU of insulin
Plain fast dissolving film
PLACEBO COMPARATORFormulated bioadhesive fast dissolving film contains no drug
Interventions
Insulin suspension vials
Fast dissolving film
Eligibility Criteria
You may qualify if:
- anosmia post covid-19 infection
You may not qualify if:
- nasal polyps or fractions or syrgery in nose from 6 months or less
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Soad Alilead
- Minia Universitycollaborator
Study Sites (1)
Soad
Minya, 05637, Egypt
Related Publications (2)
Webster KE, O'Byrne L, MacKeith S, Philpott C, Hopkins C, Burton MJ. Interventions for the prevention of persistent post-COVID-19 olfactory dysfunction. Cochrane Database Syst Rev. 2022 Sep 5;9(9):CD013877. doi: 10.1002/14651858.CD013877.pub3.
PMID: 36063364DERIVEDO'Byrne L, Webster KE, MacKeith S, Philpott C, Hopkins C, Burton MJ. Interventions for the treatment of persistent post-COVID-19 olfactory dysfunction. Cochrane Database Syst Rev. 2022 Sep 5;9(9):CD013876. doi: 10.1002/14651858.CD013876.pub3.
PMID: 36062970DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Soad Mohamed
Deraya
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 2, 2020
First Posted
December 8, 2020
Study Start
October 1, 2020
Primary Completion
February 18, 2021
Study Completion
March 20, 2021
Last Updated
October 26, 2021
Record last verified: 2021-10