Clinical trial NCT05184192: Efficacy of Gabapentin for Post-Covid-19 Olfactory Dysfunction
Official title: Efficacy of Gabapentin for Post-Covid-19 Olfactory Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Olfactory Disorder
Anosmia
Hyposmia
Parosmia
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded, randomized, placebo-controlled trial
Primary purpose: TREATMENT

Brief summary: This study will investigate the efficacy of oral gabapentin in olfactory improvement following Covid-19- associated olfactory dysfunction. This is a randomized, double-blinded, placebo-controlled trial.

Detailed description: The drug will be given over a maximum 14 weeks with up to four weeks titrating up, eight weeks maintaining highest tolerable dose, and up to two weeks tapering down. Change in olfactory function from baseline to completion of 8-week fixed-dose period will be compared between the two study groups. Follow-up assessments will be conducted for both groups 4 weeks after completion of taper down.

Eligibility criteria: Inclusion Criteria:

* Men and women between the ages of 18 and 65 years
* Residing within the states of Missouri or Illinois
* Clinically diagnosed or subjective olfactory dysfunction (anosmia, hyposmia, or parosmia) of 3 months duration or longer diagnosed within 2 weeks of Covid-19 infection
* UPSIT score consistent with diminished olfactory function (score ≤ 33 in men and ≤ 34 in women).
* Willing to respond daily to study surveys, preferably through smartphone with unlimited texting plan
* In possession of ALL 7 household items: soap, burnt candle, peanut butter, herb, garlic, lemon, and coffee

Exclusion Criteria:

* Clinically diagnosed olfactory dysfunction secondary to genetic abnormalities or congenital dysfunction, trauma, non-Covid-19 viral infection, nasal polyps, neurodegenerative disorders
* Current use of: azelastine, bromperidol, orophenadrine, oxomemazine, kratom, paraldehyde, or thalidomide
* History of addiction to alcohol, cocaine, or opioids
* Impaired renal function, myasthenia gravis, or myoclonus
* Severe allergy to peanuts
* Pregnancy or attempting pregnancy during study participation
* Inability to participate in virtual trial due to lack of access to the internet or unlimited text messaging; inability to comprehend or use English language
* Availability less than 6 months from time of enrollment
* Residency in states other than Missouri or Illinois.

Primary outcomes:
measure: Clinical Global Impression of Improvement Scale (CGI-I)
timeFrame: After the 8 week FD phase and four week post-tapper
Secondary outcomes:
measure: University of Pennsylvania Smell Identification Test (UPSIT)
timeFrame: Baseline, after completion of eight-week fixed-dose period, and 4 weeks after completion of taper-down period
measure: Olfactory Dysfunction Outcomes Rating (ODOR)
timeFrame: Baseline, after completion of eight-week fixed-dose period, and 4 weeks after completion of taper-down period
measure: NASAL-7
timeFrame: Baseline, after completion of eight-week fixed-dose period, and 4 weeks after completion of taper-down period
measure: CGI-Severity of Smell
timeFrame: 8-week Fixed-Dose period, and 4 weeks after completion of Taper-Down phase
measure: CGI-S of Parosmia
timeFrame: 8-week Fixed-Dose period, and 4 weeks after completion of Taper-Down phase
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jay F Piccirillo, MD
role: PRINCIPAL_INVESTIGATOR
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