NCT04657809

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."

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Soad Ali · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study was designed to improve smell disorders after corona infection that is very anxious for all patients. Inclusion criteria were loss of smell, post covid-19 infection, age from 18 to 70 years and accept sharing and follow up. The application of dosage form by ENT specialist at otorhinolaryngology clinic at Minia University hospital. Dose was 100iu of insulin 3 times weekly for 4 weeks. The new dosage form with insulin was compared with a placebo to ensure statistical improvement. The tests were performed in each visit. Primary outcome was the improvement of smell sensors in those patients

Conditions

• Anosmia

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Insulin film	Insulin suspension vials
DEVICE	Fast dissolving film	Fast dissolving film

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-02-18
• Completion: 2021-03-20
• First posted: 2020-12-08
• Last updated: 2021-10-26

Locations

1 site across 1 country: Egypt