Back to resultsIntranasal Insulin for COVID-19-related Smell Loss
Primary Purpose
Anosmia, Smell Loss, Paraosmia
Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Insulin
Sponsored by
About this trial
This is an interventional treatment trial for Anosmia
Eligibility Criteria
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
Sites / Locations
- Universidad Panamerican
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intranasal insulin
Arm Description
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.
Outcomes
Primary Outcome Measures
SMELL LOSS IMPROVEMENT
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05461365
Brief Title
Intranasal Insulin for COVID-19-related Smell Loss
Official Title
Intranasal Insulin for COVID-19-related Smell Loss
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
November 25, 2021 (Actual)
Study Completion Date
December 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Panamericana
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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®.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anosmia, Smell Loss, Paraosmia, Hyposmia, COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intranasal insulin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Insulin
Other Intervention Name(s)
intranasal insulin
Intervention Description
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 Measure Information:
Title
SMELL LOSS IMPROVEMENT
Time Frame
1 MONTH
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Universidad Panamerican
City
Mexico City
ZIP/Postal Code
03920
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30554358
Citation
Oleszkiewicz A, Schriever VA, Croy I, Hahner 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.
Results Reference
background
PubMed Identifier
32534982
Citation
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.
Results Reference
background
PubMed Identifier
32342636
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. No abstract available.
Results Reference
background
PubMed Identifier
29557250
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.
Results Reference
result
PubMed Identifier
33862126
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. 2021 May 15;601:120600. doi: 10.1016/j.ijpharm.2021.120600. Epub 2021 Apr 14.
Results Reference
result
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Intranasal Insulin for COVID-19-related Smell Loss
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