Intranasal Insulin for COVID-19-related Smell Loss

Phase 3

Completed

• Conditions: Smell Loss; COVID-19; Anosmia; Hyposmia; Paraosmia
• Interventions: Drug: Insulin

• Registration Number: NCT05461365
• Lead Sponsor: Universidad Panamericana

Brief Summary

The aim of this study was to quantify the improvement in olfaction of 27 post-COVID-19 patients, after three intreventions of intranasal insulin during a four week period, with the help of the Threshold, Discrimination and Identification (TDI) score evaluated with Sniffin Sticks®.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-04
• Primary Completion: 2021-11-25
• Study Completion: 2021-12-20
• Status Verified: 2022-07
• Study First Submitted: 2022-07-14
• Study First Submitted QC: 2022-07-14
• Last Update Submitted: 2022-07-14
• Study First Posted: 2022-07-18
• Last Update Posted: 2022-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• COVID-19 in the last 3 to 18 months and who persisted with anosmia, hyposmia or other olfactory dysfunction chronically and without improvement

Exclusion Criteria

• nasal tumors, chronic sinusitis, drug-induced sinusitis, nasal polyposis, neurodegenerative disease, smoking, pregnancy Hypoglycemia and a previous diagnosis of diabetes mellitus or anatomical malformations such as septal deviation, rhinosinusitis or choanal atresia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intranasal insulin	Insulin	For each selected participant (n=27), a baseline olfactory measurement was performed with Sniffin Sticks® (12 items) and a capillary glucose measurement was obtained with Dextrostix® NF before and after the intervention, in order to guarantee patient safety and reduce the risk of hypoglycemia. The initial and final measurements were divided into three subsections with a different number of correct answers for each section Subsequently, Gelfoam® cottonoids soaked in 40 IU of NPH insulin were placed on the nasal roof (between the nasal septum and the middle meatus) of each nostril. These remained in place for 15 minutes and were later removed. This procedure was performed in three visits one week apart. During the fourth and last visit (one week after the previous visit), olfaction was reevaluated using the measures previously described.

Primary Outcome Measures

Name	Time	Method
SMELL LOSS IMPROVEMENT	1 MONTH

Trial Locations

Locations (1)

Universidad Panamerican; 🇲🇽 Mexico City, Mexico