Smell in Covid-19 and Efficacy of Nasal Theophylline
Condition: Covid19; Anosmia; Olfactory Disorder; Covid-19 Pandemic; SARS-CoV-2 Infection; Hyposmia; Ageusia; Hypogeusia
MeSH terms: COVID-19; Anosmia; Ageusia
Intervention: Theophylline Powder; Placebo Comparator
Intervention description: Twice daily nasal irrigation with 400 mg theophylline capsules and USP Grade Sodium Chloride & Sodium Bicarbonate Mixture (pH balanced, Isotonic & Preservative & Iodine Free) commercially prepared packets dissolved in 240 ml of distilled water.; Twice daily nasal irrigation with 500 mg lactose powder capsules and USP Grade Sodium Chloride & Sodium Bicarbonate Mixture (pH balanced, Isotonic & Preservative & Iodine Free) commercially prepared packets dissolved in 240 ml of distilled water.
Intervention MeSH terms: Theophylline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: The pharmacy will maintain the blind until the completion of the study.
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Smell; Smell loss; smell dysfunction; olfactory dysfunction; COVID-19; anosmia; theophylline; nasal irrigation

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