Smell in Covid-19 and Efficacy of Nasal Theophylline

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Theophylline

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