Fluvoxamine to Augment Olfactory Recovery For Long COVID-19 Parosmia

• Status: Not yet recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

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

Criteria

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.