Status:

COMPLETED

Smell in Covid-19 and Efficacy of Nasal Theophylline

Lead Sponsor:

Washington University School of Medicine

Conditions:

Covid19

Anosmia

Eligibility:

All Genders

18-70 years

Phase:

PHASE2

Brief 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 olfacto...

Detailed Description

Post-viral olfactory dysfunction has numerous known adverse effects such as loss of cortical gray matter and decrease in quality of life. COVID-19 related olfactory dysfunction has already been shown ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 15 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 30 2021

Estimated Enrollment :

51 Patients enrolled

Trial Details

Trial ID

NCT04789499

Start Date

March 15 2021

End Date

December 30 2021

Last Update

May 24 2023

Active Locations (1)

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Washington University School of Medicine in Saint Louis

St Louis, Missouri, United States, 63110