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

The Washington University

Status and phase: Withdrawn; Phase 2

Conditions: COVID-19; Parosmia; Olfactory Disorder

Treatments: Drug: Fluvoxamine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05216614

202111124

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Fluvoxamine

Experimental group

Description:

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.

Treatment:

Drug: Fluvoxamine

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo