Phase 2
Completed N=68
Efficacy of Gabapentin for Post-Covid-19 Olfactory Dysfunction
COVID · Olfactory Disorder · Anosmia · Hyposmia
Source: ClinicalTrials.gov NCT05184192 ↗
Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Clinical Global Impression of Improvement Scale (CGI-I) — 8; 20; 7; 12 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Global Impression of Improvement Scale (CGI-I) |
8; 20; 7; 12 | — |
| SECONDARY University of Pennsylvania Smell Identification Test (UPSIT) |
23; 24; 25; 25; 26; 25 | — |
| SECONDARY Olfactory Dysfunction Outcomes Rating (ODOR) |
23; 54.5; 25.5; 49.9; 25; 45 | — |
| SECONDARY NASAL-7 |
6; 10; 8; 12; 2; 3 | — |
| SECONDARY CGI-Severity of Smell |
4; 4; 12; 16; 1; 4 | — |
| SECONDARY CGI-S of Parosmia |
7; 6; 9; 8; 2; 7 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05184192). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.