Treatment of Pediatric Patients That Lost Sense of Smell Due to COVID-19

NCT04964414 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: STUDY21050012
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is a randomized controlled trial in pediatric and young adult patients who have lost their sense of smell due to COVID-19 viral infection. The goals are:

1. 1.to learn more about the effects of smell retraining therapy on smell loss following COVID-19 and
2. 2.to determine if budesonide-saline irrigations make smell retraining therapy more effective.

Conditions

Dysosmia; Anosmia; Covid19

Keywords

Sino-Nasal Outcome Test; Smell Test

Outcome Measures

Primary Outcomes (1)

• Change in University of Pennsylvania Smell Identification Test (UPSIT) Score From Baseline to First Follow-up

  Change in University of Pennsylvania Smell Identification Test (UPSIT) score from baseline at the initial consult appointment to the first follow-up appointment at 8 weeks (range 8 to 12 weeks). The UPSIT is a smell identification test and is a 40-item scratch and sniff test with a four-choice multiple choice question on each of the 10 pages in the booklet. Indication of smell loss can be determined - anosmia (total loss) and mild, moderate, or severe microsomia and a detection for malingering. The minimum possible score is a 0 and the maximum is a 40. A higher score indicates better smell/outcome.

  Before and after 8-12 weeks of smell retraining

Secondary Outcomes (6)

• Change in Sino-nasal Outcome Test-22 (SNOT-22) Score From Baseline to First Follow-up

  Before and after 8-12 weeks of smell retraining

• Change in Loss of Smell Question Score From Baseline to First Follow-up

  Before and after 8-12 weeks of smell retraining

• Change in University of Pennsylvania Smell Identification Test (UPSIT) Score From Baseline to 6 Month Follow-up

  Baseline and 6 months after initial consult appointment

• Change in Sino-nasal Outcome Test-22 (SNOT-22) Score From Baseline to 6 Month Follow-up

  Baseline and 6 months after initial consult appointment

• Change in University of Pennsylvania Smell Identification Test (UPSIT) Score From Baseline to 12 Month Follow-up

  Baseline and 12 months after initial consult appointment

Other Outcomes (2)

• Change in Loss of Taste Question Score From Baseline to First Follow-up

  Before and after 8-12 weeks of smell retraining

• Change in Anxiety Question Score From Baseline to First Follow-up

  Before and after 8-12 weeks of smell retraining

Study Arms (2)

Smell Retraining Only

ACTIVE COMPARATOR

Participants will undergo smell retraining for 8 weeks. Each week, participants will choose 4 scents. They will smell each item for 15 seconds very close to the nose once a day.

Other: Smell Retraining

Smell Retraining + Budesonide

EXPERIMENTAL

Participants will undergo smell retraining as described above. They will also complete budesonide irrigations once a day by pouring 0.5mg/2ml of budesonide into a irrigation bottle with saline and irrigating the nose.

Other: Smell Retraining; Drug: Budesonide

Interventions

Smell Retraining OTHER

Smell practice with household scented items

Also known as: Smell Training, Olfactory Retraining

Smell Retraining + Budesonide; Smell Retraining Only

Budesonide DRUG

Nasal irrigation with liquid steroid

Also known as: Nasal Glucocorticoid Irrigation

Smell Retraining + Budesonide

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects ages 6 to 21 who have loss of smell (anosmia) or dysosmia (disordered smell perception) and thought to have occurred due to COVID-19.
• Subjects who are able to complete the smell test (UPSIT), self-report their loss of smell, and do the assigned daily therapy.

You may not qualify if:

• Duration of anosmia or dysosmia \<60 days
• Previous smell retraining
• Prior interventions for loss of smell (excluding those on Flonase and Azelastine)
• Contraindications for nasal budesonide treatment, as determined by the treating physician
• Active cigarette smoker or use of vapes
• Previous head trauma
• Congenital anosmia
• History of brain tumor
• Neurocognitive disorders
• Multiple sclerosis
• Seizure disorder
• Cystic fibrosis
• Primary Ciliary Dyskinesia
• History of nasal polyps
• Inability to self-report

Sponsors & Collaborators

• Amanda Stapleton: lead

Study Sites (1)

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Olfaction Disorders; Anosmia; COVID-19

Interventions

Olfactory Training; Budesonide

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

Early termination and significant loss to follow-up leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Dr. Amber Shaffer
• Organization: UPMC Children's Hospital of Pittsburgh

shafferad@upmc.edu

412-692-6874

Study Officials

• Amanda L Stapleton, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 16, 2021
• Study Start: September 30, 2021
• Primary Completion: January 13, 2023
• Study Completion: March 29, 2023
• Last Updated: June 13, 2024
• Results First Posted: February 8, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 1 year after publication of summary data. Ending 5 years after publication.
• Access Criteria: Proposals should be directed to shafferad@upmc.edu. To gain access, data requestors will need to sign data access agreement.

Locations

US (1)