Phase 2 N=51 Randomized Double-blind Treatment

Smell in Covid-19 and Efficacy of Nasal Theophylline

Covid19 · Anosmia · Olfactory Disorder · Covid-19 Pandemic · SARS-CoV-2 Infection

Bottom Line

View on ClinicalTrials.gov: NCT04789499 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2023

Primary outcome: Primary: UPSIT — 59; 43 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Theophylline Powder (Drug); Placebo Comparator (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: Dec 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY UPSIT	59; 43	—
SECONDARY University of Pennsylvania Smell Identification Test (UPSIT)	3; 0	—
SECONDARY Change in Questionnaire for Olfactory Dysfunction (QOD) From Baseline to 6 Weeks Post Intervention	0.86; 1.43	—
SECONDARY 36-Item Short Form Health Survey (SF-36)	75; 80	—
SECONDARY Olfactory Dysfunction Outcomes Rating (ODOR)	-6.5; -4.5	—

Summary

Evidence of COVID-19 related anosmia and dysgeusia continues to accumulate daily. Currently, up to 80% of patients report subjective olfactory dysfunction (OD), and prevalence using objective olfactory testing could be even higher. We propose a phase II single-site, double-blinded, placebo-controlled randomized clinical trial to determine the efficacy and safety of intranasal theophylline, a known phosphodiesterase inhibitor in the treatment of asthma, as a possible treatment for COVID-19 related OD. Theophylline has shown benefit in similar clinical trials for post-viral OD.

Eligibility Criteria

Inclusion Criteria

Olfactory dysfunction that has persisted for >3 months following suspected COVID-19 infection
Residing within the states of Missouri or Illinois.
Can read, write, and understand English.

Exclusion Criteria

History of olfactory dysfunction prior to COVID-19 infection
Use of concomitant therapies specifically for the treatment of olfactory dysfunction
History of olfactory dysfunction longer than 12 months
Known existence of nasal polyps, prior sinonasal, or anterior skull-based surgery
Dependence on theophylline for comorbid conditions such as asthma and COPD
History of an allergic reaction to theophylline or other methylxanthines
History of neurodegenerative disease (ie. Alzheimer's dementia, Parkinson's disease, Lewy body dementia, frontotemporal dementia)
Pregnant or breastfeeding mothers
Current use of medications with significant interactions with theophylline, which include cimetidine, ciprofloxacin, disulfiram, enoxacin, fluvoxamine, interferon-alpha, lithium, mexiletine, phenytoin, propafenone, propranolol, tacrine, thiabendazole, ticlopidine, and troleandomycin.
Pre-existing arrhythmias or seizures

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Data sourced from ClinicalTrials.gov (NCT04789499). 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.