Overview

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.