Trial Outcomes & Findings for Treatment of Pediatric Patients That Lost Sense of Smell Due to COVID-19 (NCT NCT04964414)

Last Updated: 2024-06-13

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Before and after 8-12 weeks of smell retraining

Results posted on

2024-06-13

Participant Flow

One participant was placed in a treatment arm (OT + BI) different than what was randomly assigned (OT) at the initial clinic visit.

Participant milestones

Participant milestones
Measure	Smell Retraining Only 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. Smell Retraining: Smell practice with household scented items	Smell Retraining + Budesonide 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. Smell Retraining: Smell practice with household scented items Budesonide: Nasal irrigation with liquid steroid
Overall Study STARTED	11	9
Overall Study 8-12 Week Follow-up	7	1
Overall Study 6 Month Follow-up	3	0
Overall Study 12 Month Follow-up	0	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	11	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Smell Retraining Only 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. Smell Retraining: Smell practice with household scented items	Smell Retraining + Budesonide 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. Smell Retraining: Smell practice with household scented items Budesonide: Nasal irrigation with liquid steroid
Overall Study Lost to Follow-up	10	8
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Smell Retraining Only n=11 Participants 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. Smell Retraining: Smell practice with household scented items	Smell Retraining + Budesonide n=9 Participants 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. Smell Retraining: Smell practice with household scented items Budesonide: Nasal irrigation with liquid steroid	Total n=20 Participants Total of all reporting groups
Age, Continuous	13 years n=93 Participants	16 years n=4 Participants	16 years n=27 Participants
Age, Customized 7-12 years	5 Participants n=93 Participants	0 Participants n=4 Participants	5 Participants n=27 Participants
Age, Customized 13-18 years	6 Participants n=93 Participants	9 Participants n=4 Participants	15 Participants n=27 Participants
Age, Customized 19-21 years	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	7 Participants n=4 Participants	15 Participants n=27 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=93 Participants	8 Participants n=4 Participants	19 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) White	10 Participants n=93 Participants	8 Participants n=4 Participants	18 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Primary Complaint Abnormal Smell and Taste	6 Participants n=93 Participants	8 Participants n=4 Participants	14 Participants n=27 Participants
Primary Complaint Abnormal Smell Only	5 Participants n=93 Participants	1 Participants n=4 Participants	6 Participants n=27 Participants
Symptom Onset Post-COVID-19 Immediate	7 Participants n=93 Participants	7 Participants n=4 Participants	14 Participants n=27 Participants
Symptom Onset Post-COVID-19 Delayed	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Symptom Onset Post-COVID-19 Unknown	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Medical History Allergic Rhinitis · Yes	0 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants
Medical History Allergic Rhinitis · No	11 Participants n=93 Participants	6 Participants n=4 Participants	17 Participants n=27 Participants
Medical History Environmental Allergies · Yes	0 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants
Medical History Environmental Allergies · No	11 Participants n=93 Participants	6 Participants n=4 Participants	17 Participants n=27 Participants
Medical History Immunosuppression · Yes	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Medical History Immunosuppression · No	10 Participants n=93 Participants	8 Participants n=4 Participants	18 Participants n=27 Participants
Medical History Deviated Septum · Yes	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Medical History Deviated Septum · No	11 Participants n=93 Participants	8 Participants n=4 Participants	19 Participants n=27 Participants
Medical History History of Radiation · Yes	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Medical History History of Radiation · No	11 Participants n=93 Participants	8 Participants n=4 Participants	19 Participants n=27 Participants
Vaccinated against COVID-19 Yes	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Vaccinated against COVID-19 No	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Vaccinated against COVID-19 Unknown	7 Participants n=93 Participants	8 Participants n=4 Participants	15 Participants n=27 Participants

PRIMARY outcome

Timeframe: Before and after 8-12 weeks of smell retraining

Population: Patients who completed 8-12 week follow-up assessments

Outcome measures

Outcome measures
Measure	Smell Retraining Only n=7 Participants 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. Smell Retraining: Smell practice with household scented items	Smell Retraining + Budesonide n=1 Participants 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. Smell Retraining: Smell practice with household scented items Budesonide: Nasal irrigation with liquid steroid
Change in University of Pennsylvania Smell Identification Test (UPSIT) Score From Baseline to First Follow-up Before smell retraining	23.3 score on a scale Standard Deviation 7.3	34 score on a scale
Change in University of Pennsylvania Smell Identification Test (UPSIT) Score From Baseline to First Follow-up After 8-12 weeks of smell retraining	22.3 score on a scale Standard Deviation 7.3	35 score on a scale

SECONDARY outcome

Timeframe: Before and after 8-12 weeks of smell retraining

Population: Patients who completed 8-12 week follow-up assessments

Change in Sino-nasal Outcome Test-22 (SNOT-22) score from baseline at the initial consult appointment to the first follow-up appointment at 8 weeks (range 8 to 12 weeks). The SNOT-22 is a 22 question survey that asks about symptoms and social/emotional consequences of a nasal disorder. The survey is on a 6 point scale - No problem (0), very mild problem (1), mild or slight problem (2), moderate problem (3), severe problem (4), and problem as bad as it can be (5). The minimum possible score is 0 and the maximum is 110. A higher score indicates more sino-nasal symptoms/worse outcome.

Outcome measures

Outcome measures
Measure	Smell Retraining Only n=7 Participants 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. Smell Retraining: Smell practice with household scented items	Smell Retraining + Budesonide n=1 Participants 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. Smell Retraining: Smell practice with household scented items Budesonide: Nasal irrigation with liquid steroid
Change in Sino-nasal Outcome Test-22 (SNOT-22) Score From Baseline to First Follow-up Before smell retraining	23 score on a scale Interval 10.0 to 41.0	37 score on a scale
Change in Sino-nasal Outcome Test-22 (SNOT-22) Score From Baseline to First Follow-up After 8-12 weeks of smell retraining	25 score on a scale Interval 11.0 to 37.0	39 score on a scale

SECONDARY outcome

Timeframe: Before and after 8-12 weeks of smell retraining

Population: Patients who returned the smell diary and completed the loss of smell scale before and after 8-12 weeks of smell retraining

Change in loss of smell on a 0-10 scale from baseline at the initial consult appointment to the first follow-up appointment at 8 weeks (range 8 to 12 weeks). Subjects are asked to rate the symptom severity of loss of smell from 0 (no loss) to 10 (total loss). A higher score indicates worse smell/outcome.

Outcome measures

Outcome measures
Measure	Smell Retraining Only n=5 Participants 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. Smell Retraining: Smell practice with household scented items	Smell Retraining + Budesonide n=1 Participants 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. Smell Retraining: Smell practice with household scented items Budesonide: Nasal irrigation with liquid steroid
Change in Loss of Smell Question Score From Baseline to First Follow-up Before smell retraining	6.0 score on scale Standard Deviation 3.3	6.0 score on scale
Change in Loss of Smell Question Score From Baseline to First Follow-up After 8-12 weeks of smell retraining	5.0 score on scale Standard Deviation 3.7	8.0 score on scale

SECONDARY outcome

Timeframe: Baseline and 6 months after initial consult appointment

Population: Patients who completed 6 month follow-up assessments

Change in University of Pennsylvania Smell Identification Test (UPSIT) score from baseline at the initial consult appointment to the 6 month follow-up appointment. The minimum possible score is a 0 and the maximum is a 40. A higher score indicates better smell/outcome.

Outcome measures

Outcome measures
Measure	Smell Retraining Only n=3 Participants 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. Smell Retraining: Smell practice with household scented items	Smell Retraining + Budesonide 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. Smell Retraining: Smell practice with household scented items Budesonide: Nasal irrigation with liquid steroid
Change in University of Pennsylvania Smell Identification Test (UPSIT) Score From Baseline to 6 Month Follow-up Before smell retraining	15 score on scale Interval 13.0 to 21.0	—
Change in University of Pennsylvania Smell Identification Test (UPSIT) Score From Baseline to 6 Month Follow-up After 6 months of smell retraining	17 score on scale Interval 14.0 to 24.0	—

SECONDARY outcome

Timeframe: Baseline and 6 months after initial consult appointment

Population: Patients who completed 6 month follow-up assessments

Change in Sino-nasal Outcome Test-22 (SNOT-22) score from baseline at the initial consult appointment to the 6 month follow-up appointment. The minimum possible score is 0 and the maximum is 110. A higher score indicates more sino-nasal symptoms/worse outcome.

Outcome measures

Outcome measures
Measure	Smell Retraining Only n=3 Participants 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. Smell Retraining: Smell practice with household scented items	Smell Retraining + Budesonide 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. Smell Retraining: Smell practice with household scented items Budesonide: Nasal irrigation with liquid steroid
Change in Sino-nasal Outcome Test-22 (SNOT-22) Score From Baseline to 6 Month Follow-up Before smell retraining	25 score on a scale Interval 15.0 to 41.0	—
Change in Sino-nasal Outcome Test-22 (SNOT-22) Score From Baseline to 6 Month Follow-up After 6 months of smell retraining	9 score on a scale Interval 8.0 to 14.0	—

SECONDARY outcome

Timeframe: Baseline and 12 months after initial consult appointment

Population: Patients who completed 12 month follow-up assessments

Change in University of Pennsylvania Smell Identification Test (UPSIT) score from baseline at the initial consult appointment to the 12 month follow-up appointment. The minimum possible score is a 0 and the maximum is a 40. A higher score indicates better smell/outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 12 months after initial consult appointment

Population: Patients who completed 12 month follow-up assessments

Change in Sino-nasal Outcome Test-22 (SNOT-22) score from baseline at the initial consult appointment to the 12 month follow-up appointment. The minimum possible score is 0 and the maximum is 110. A higher score indicates more sino-nasal symptoms/worse outcome.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Before and after 8-12 weeks of smell retraining

Population: Patients who returned the smell diary and completed the loss of taste scale before and after 8-12 weeks of smell retraining

Change in loss of taste on a 0-10 scale from baseline at the initial consult appointment to the first follow-up appointment at 8 weeks (range 8 to 12 weeks). Subjects are asked to rate the symptom severity of loss of taste from 0 (no loss) to 10 (total loss). A higher score indicates less taste/worse outcome.

Outcome measures

Outcome measures
Measure	Smell Retraining Only n=5 Participants 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. Smell Retraining: Smell practice with household scented items	Smell Retraining + Budesonide n=1 Participants 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. Smell Retraining: Smell practice with household scented items Budesonide: Nasal irrigation with liquid steroid
Change in Loss of Taste Question Score From Baseline to First Follow-up Before smell retraining	3.6 score on scale Standard Deviation 3.8	6.0 score on scale
Change in Loss of Taste Question Score From Baseline to First Follow-up After 8-12 weeks of smell retraining	1.6 score on scale Standard Deviation 2.1	8.0 score on scale

OTHER_PRE_SPECIFIED outcome

Timeframe: Before and after 8-12 weeks of smell retraining

Change in anxiety on a 0-10 scale from baseline at the initial consult appointment to the first follow-up appointment at 8 weeks (range 8 to 12 weeks). Subjects are asked to rate the symptom severity of anxiety from 0 (no anxiety) to 10 (worst possible anxiety). A higher score indicates more anxiety/worse outcome.

Outcome measures

Outcome measures
Measure	Smell Retraining Only n=5 Participants 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. Smell Retraining: Smell practice with household scented items	Smell Retraining + Budesonide n=1 Participants 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. Smell Retraining: Smell practice with household scented items Budesonide: Nasal irrigation with liquid steroid
Change in Anxiety Question Score From Baseline to First Follow-up Before smell retraining	5.0 score on a scale Standard Deviation 4.4	7.0 score on a scale
Change in Anxiety Question Score From Baseline to First Follow-up After 8-12 weeks of smell retraining	3.4 score on a scale Standard Deviation 4.4	8.5 score on a scale

Adverse Events

Smell Retraining Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Smell Retraining + Budesonide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Amber Shaffer

UPMC Children's Hospital of Pittsburgh

Phone: 412-692-6874

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place