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CompletedNCT05461365Updated Jul 18, 2022

Intranasal Insulin for COVID-19-related Smell Loss

A Phase 3 interventional study of Insulin in Anosmia, Smell Loss and Paraosmia, sponsored by Universidad Panamericana. Completed at 1 site in Mexico. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2022-07-18.

Sponsored by Universidad Panamericana · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Jan 2021, registered Jul 2022).
Phase
Phase 3
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Ages
18 Years to 59 Years
Sex
All
01

Study 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®.

02

Conditions studied

  • Anosmia
  • Smell Loss
  • Paraosmia
  • Hyposmia
  • COVID-19
03

In context

Anosmia

180 studies on the registry are indexed under Anosmia; 45 are open to participants now.

This study's enrollment of 27 is below the median of 60 across 114 interventional studies indexed under Anosmia.

Browse Anosmia studies →

Lead sponsor

Universidad Panamericana is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • 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

Interventions

  • DrugInsulin

    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.

    Also known as: intranasal insulin

06

What researchers measure

Primary outcomes

  1. SMELL LOSS IMPROVEMENT

    Time frame: 1 MONTH

07

Study locations

1 site
  • Universidad Panamerican
    Mexico City, 03920, Mexico
08

References and documents

Publications

  • 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. PubMed 30554358 ↗
  • 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. PubMed 32534982 ↗
  • 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. PubMed 32342636 ↗
  • 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. PubMed 29557250 ↗
  • 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. PubMed 33862126 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2021 to primary completion in Nov 2021, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 14, 2022
First posted
Jul 18, 2022
StartActual
Jan 4, 2021
Primary completionActual
Nov 25, 2021
CompletionActual
Dec 20, 2021
Last update
Jul 18, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05461365
Lead sponsor
Universidad Panamericana
Responsible party
Daniel Dibildox Reynoso (Professor, Universidad Panamericana) — Principal investigator
First posted
Jul 18, 2022
Start date
Jan 4, 2021
Primary completion
Nov 25, 2021
Completion
Dec 20, 2021
Last update
Jul 18, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Insulin

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