Clinical trial NCT05216614: Fluvoxamine to Augment Olfactory Recovery For Long COVID-19 Parosmia
Official title: Fluvoxamine to Augment Olfactory Recovery For Long COVID-19 Parosmia (FluCOP Trial)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: COVID-19
Olfactory Disorder
Parosmia
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded, randomized, placebo-controlled trial
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility 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.

Primary outcomes:
measure: Clinical Global Impression Scale (CGI)
timeFrame: CGI-S and CGI-P will be administered at Baseline and Week 12 after completion of fixed-dose period, prior to taper down, to measure change. CGI-I will be administered at Week 12 after completion of fixed-dose period, prior to taper down
Secondary outcomes:
measure: University of Pennsylvania Smell Identification Test (UPSIT)
timeFrame: Baseline and Week 12 after completion of fixed-dose period, prior to taper down, to measure change from baseline
measure: Olfactory Dysfunction Outcomes Rating (ODOR)
timeFrame: Baseline and Week 12 after completion of fixed-dose period, prior to taper down, to measure change from baseline
measure: The Depression, Anxiety and Stress Scale - 21 Items (DASS-21)
timeFrame: Baseline and Week 12 after completion of fixed-dose period, prior to taper down, to measure change from baseline
measure: The Smell Catastrophizing Scale (SCS)
timeFrame: Baseline and Week 12 after completion of fixed-dose period, prior to taper down, to measure change from baseline
measure: 36-Item Short Form Health Survey (SF-36)
timeFrame: Baseline and Week 12 after completion of fixed-dose period, prior to taper down, to measure change from baseline
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jay F Piccirillo, MD
role: PRINCIPAL_INVESTIGATOR
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