Intranasal Insulin for COVID-19-related Smell Loss

COVID-19 Clinical Trial

Official title:

Intranasal Insulin for COVID-19-related Smell Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05461365
• Other study ID #: 01007
• Status: Completed
• Phase: Phase 3
• Start date: January 4, 2021
• Est. completion date: December 20, 2021

Study information

• Verified date: July 2022
• Source: Universidad Panamericana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 20, 2021
• Est. primary completion date: November 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Anosmia
• COVID-19
• Hyposmia
• Olfaction Disorders

Intervention

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.

Locations

Country	Name	City	State
Mexico	Universidad Panamerican	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Panamericana

Country where clinical trial is conducted

Mexico, 

References & Publications (5)

Kosugi EM, Lavinsky J, Romano FR, Fornazieri MA, Luz-Matsumoto GR, Lessa MM, Piltcher OB, Sant'Anna GD. Incomplete and late recovery of sudden olfactory dysfunction in COVID-19. Braz J Otorhinolaryngol. 2020 Jul - Aug;86(4):490-496. doi: 10.1016/j.bjorl.2020.05.001. Epub 2020 May 25. — View Citation

Mohamad SA, Badawi AM, Mansour HF. 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. Int J Pharm. 2 — View Citation

Oleszkiewicz A, Schriever VA, Croy I, Hähner A, Hummel T. Updated Sniffin' Sticks normative data based on an extended sample of 9139 subjects. Eur Arch Otorhinolaryngol. 2019 Mar;276(3):719-728. doi: 10.1007/s00405-018-5248-1. Epub 2018 Dec 15. — View Citation

Rezaeian A. Effect of Intranasal Insulin on Olfactory Recovery in Patients with Hyposmia: A Randomized Clinical Trial. Otolaryngol Head Neck Surg. 2018 Jun;158(6):1134-1139. doi: 10.1177/0194599818764624. Epub 2018 Mar 20. — View Citation

Vaira LA, Salzano G, Fois AG, Piombino P, De Riu G. Potential pathogenesis of ageusia and anosmia in COVID-19 patients. Int Forum Allergy Rhinol. 2020 Sep;10(9):1103-1104. doi: 10.1002/alr.22593. Epub 2020 Jun 15. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SMELL LOSS IMPROVEMENT		1 MONTH