Fluvoxamine to Augment Olfactory Recovery For Long COVID-19 Parosmia (NCT05216614) | Clinical Trial Compass
WithdrawnPhase 2
Fluvoxamine to Augment Olfactory Recovery For Long COVID-19 Parosmia
Stopped: Unable to obtain investigational product
United States0Started 2021-12-14
Plain-language 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.
Who can participate
Age range18 Years ā 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 metaboliā¦
What they're measuring
1
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