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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Double-blinded, randomized, placebo-controlled trial
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
double-blinded, both participants and investigators will be blinded. Intervention will be packaged in blinded fashion by pharmacist before being shipped to participants by research assistant

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Fluvoxamine 		This arm will be given the active treatment, oral fluvoxamine capsules of 25 mg each. The first six weeks will be gradual titration (weeks 1 & 2 25mg BID, weeks 3 & 4 75mg BID, weeks 5 & 6 100mg BID). The following six weeks will be fixed dose of 100mg TID. The last two weeks will be a taper down (first week 50mg BID and second week 25mg BID) There will be 14 weeks of active treatment and assessments will be conducted after completion of week 12, prior to beginning taper down period.
  • Drug: Fluvoxamine
    Fluvoxamine is an SSRI used for depression and anxiety disorders. This study will investigate the efficacy of fluvoxamine for improvement of olfactory dysfunction in subjects with post-Covid-19 parosmia.
    Other names:
    • Luvox
Placebo Comparator
Placebo 		Placebo capsules that look, smell, and taste like fluvoxamine capsules will be given to the placebo arm. To preserve double-blinding of the study, subjects will receive one capsule BID during the first six weeks following the titration schedule and one capsule TID during the next six weeks for the fixed-dose period. Subjects will then taper-down placebo to imitate the fluvoxamine arm for two weeks. Assessments will be conducted at 12 weeks following completion of fixed-dose period, prior to starting taper down period.
  • Drug: Placebo
    lactose placebo capsules identical to fluvoxamine capsules in order to preserve blind

Recruiting Locations

More Details

NCT ID
NCT05216614
Status
Withdrawn
Sponsor
Washington University School of Medicine

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.