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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04657809

Enrollment

Registered

2020-12-08

Start date

2020-10-01

Completion date

2021-03-20

Last updated

2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anosmia

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.

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

Interventions

COMBINATION_PRODUCTInsulin film

Insulin suspension vials

DEVICEFast dissolving film

Fast dissolving film

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* anosmia post covid-19 infection

Exclusion criteria

* nasal polyps or fractions or syrgery in nose from 6 months or less

Design outcomes

Primary

Measure	Time frame	Description
Smell sensation improvement	4 weeks	By decrease the threshold sensation with butanol test

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026