A Phase 2 interventional study of Fluvoxamine and Placebo in COVID-19, Olfactory Disorder and Parosmia, sponsored by Washington University School of Medicine. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-03-11.
Sponsored by Washington University School of Medicine · Phase 2, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Also known as: Luvox
lactose placebo capsules identical to fluvoxamine capsules in order to preserve blind
Clinical Global Impression Scale (CGI)
The CGI has two components - the CGI-Severity and the CGI-Improvement. Scores on the CGI-Severity Scale range from 1 to 7 (1 is Normal, 7 is Complete loss of smell) and provide information on the patient's perceived severity of their dysfunction at baseline. The score on the CGI-Improvement Scale ranges from 1 to 7 (1 is Very Much Improved, 7 is Very Much Worsened). Each rating is well defined to maximize accuracy. Participants reporting 3 as Minimally Improved, 2 as Much Improved, or 1 as Very Much Improved in the CGI-I will be deemed responders to treatment, and the number of responders to non-responders will be compared between the two arms. The Clinical Global Impression-Severity Scale for Parosmia (CGI-P) will also be used. The CGI-P Scale ranges from 1 to 5, where 1 is No Distortion, 2 is Mild Distortion, 3 is Moderate Distortion, 4 is Mostly Distorted, and 5 is Complete Distortion.
Time frame: 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
University of Pennsylvania Smell Identification Test (UPSIT)
The UPSIT is composed of 40 strips of microencapsulated odorants, which are present on the bottom of each page, just below a four-alternative multiple-choice question. For a given item, the patient releases an odor by scratching the microencapsulated pad with a pencil tip, smells the pad, and indicates the odor quality from four alternatives. Even if no smell is perceived, a response is required (i.e., the test is forced-choice). The subject's total correct score out of the 40 items is determined and provides an objective measure of olfactory function.
Time frame: Baseline and Week 12 after completion of fixed-dose period, prior to taper down, to measure change from baseline
Olfactory Dysfunction Outcomes Rating (ODOR)
The ODOR questionnaire is a 28-item disease-specific health status survey to assess the physical problems, functional impairments, and emotional consequences secondary to olfactory dysfunction. ODOR was developed and validated by Dr. Jake Lee and colleagues in the Clinical Outcomes Research Office at Washington University
Time frame: Baseline and Week 12 after completion of fixed-dose period, prior to taper down, to measure change from baseline
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21)
The DASS-21 is a set of three self-report scales designed to measure the emotional state of depression, anxiety, and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic non- specific arousal and assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items.
Time frame: Baseline and Week 12 after completion of fixed-dose period, prior to taper down, to measure change from baseline
The Smell Catastrophizing Scale (SCS)
The SCS is a 13-item scale that asks the participants to describe the degree to which they have specific thoughts and feelings as a result of their sense of smell problems.
Time frame: Baseline and Week 12 after completion of fixed-dose period, prior to taper down, to measure change from baseline
36-Item Short Form Health Survey (SF-36)
The SF-36 is a 36-item questionnaire evaluating physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. This test allows us to study the general health overall quality of life changes for those suffering from COVID-19 related OD.
Time frame: Baseline and Week 12 after completion of fixed-dose period, prior to taper down, to measure change from baseline
Plan to share: No
This study is withdrawn, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fluvoxamine
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