Fluvoxamine to Augment Olfactory Recovery For Long COVID-19 Parosmia

Fluvoxamine to Augment Olfactory Recovery For Long COVID-19 Parosmia (FluCOP Trial)

This study will investigate the efficacy of oral fluvoxamine in olfactory improvement following Covid-19- associated parosmia. This is a randomized, double-blinded, placebo-controlled trial.

The drug will be given over a 14 weeks with six weeks titrating up, six weeks maintaining highest dose, and up to two weeks tapering down. Assessments will be collected following week 12 to measure change in olfactory function from baseline between the two study groups.

Inclusion Criteria:

• Men and women between the ages 18 to 70 years
• Residing within the states of Missouri or Illinois
• Complaints of odors of certain things or everything are distorted
• Olfactory dysfunction that has persisted for >2 months after suspected COVID-19 infection
• Ability to read, write, and understand English

Exclusion Criteria:

• History of olfactory dysfunction prior to COVID-19 infection
• Any use of concomitant therapies specifically for the treatment of olfactory dysfunction
• History of olfactory dysfunction of longer than 12 months
• History of bipolar disorder as SSRIs can theoretically destabilize bipolar disorder
• Participants with symptoms of depression as evidenced by a score of 10 or greater on the Patient Health Questionnaire-9 (PHQ-9).95 The PHQ-9 is a nine-item questionnaire designed to assess and aid in diagnosing patients with depression in clinical and community settings.
• History of neurodegenerative disease (i.e., Alzheimer's dementia, Parkinson's disease, Lewy body dementia, frontotemporal dementia)
• History of chronic rhinosinusitis or sinus surgery
• Pregnant or breastfeeding mothers.
• Already enrolled in another COVID 19 medication trial or receipt of monoclonal antibody infusion.
• Taking donepezil or fluoxetine (rationale: these drugs are S1R agonists) or sertraline (a S1R antagonist).
• Participants taking theophylline, tizanidine, clozapine, or olanzapine (drugs with a narrow therapeutic index that are primarily metabolized by CYP 1A2, which is inhibited by fluvoxamine.
• Taking another SSRI, unless at a low dose (e.g., escitalopram 5mg) such that adding fluvoxamine would not put patient at risk for serotonin syndrome.
• Taking coumadin based on theoretical risk of increased bleeding with fluvoxamine.
• Unable to provide informed consent.
• Unable to perform the study procedures.