Intranasal Insulin for COVID-19-related Smell Loss

Sponsor

Universidad Panamericana (Other)

Overall Status

Completed

CT.gov ID

NCT05461365

Collaborator

(none)

Enrollment

Location

Arm

11.5

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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®.

Condition or Disease	Intervention/Treatment	Phase
Anosmia Smell Loss Paraosmia Hyposmia COVID-19	Drug: Insulin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Intranasal Insulin for COVID-19-related Smell Loss

Actual Study Start Date :

Jan 4, 2021

Actual Primary Completion Date :

Nov 25, 2021

Actual Study Completion Date :

Dec 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intranasal 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.	Drug: Insulin 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. Other Names: intranasal insulin

Arm

Intervention/Treatment

Experimental: intranasal 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.

Drug: Insulin

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.

Other Names:

intranasal insulin

Outcome Measures

Primary Outcome Measures

SMELL LOSS IMPROVEMENT [1 MONTH]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 59 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad Panamerican	Mexico City		Mexico	03920

Sponsors and Collaborators

Universidad Panamericana

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Daniel Dibildox Reynoso, Professor, Universidad Panamericana

ClinicalTrials.gov Identifier:

NCT05461365

Other Study ID Numbers:

01007

First Posted:

Jul 18, 2022

Last Update Posted:

Jul 18, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 18, 2022