Fluvoxamine to Augment Olfactory Recovery For Long COVID-19 Parosmia (FluCOP)
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|ClinicalTrials.gov Identifier: NCT05216614|
Recruitment Status : Withdrawn (Unable to obtain investigational product)
First Posted : January 31, 2022
Last Update Posted : March 11, 2022
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 Olfactory Disorder Parosmia||Drug: Fluvoxamine Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double-blinded, randomized, placebo-controlled trial|
|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|
|Official Title:||Fluvoxamine to Augment Olfactory Recovery For Long COVID-19 Parosmia (FluCOP Trial)|
|Actual Study Start Date :||December 14, 2021|
|Actual Primary Completion Date :||February 22, 2022|
|Actual Study Completion Date :||February 22, 2022|
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.
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 Name: 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.
lactose placebo capsules identical to fluvoxamine capsules in order to preserve blind
- Clinical Global Impression Scale (CGI) [ 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 ]
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.
- University of Pennsylvania Smell Identification Test (UPSIT) [ Time Frame: Baseline and Week 12 after completion of fixed-dose period, prior to taper down, to measure change from baseline ]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.
- Olfactory Dysfunction Outcomes Rating (ODOR) [ Time Frame: Baseline and Week 12 after completion of fixed-dose period, prior to taper down, to measure change from baseline ]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
- The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) [ Time Frame: Baseline and Week 12 after completion of fixed-dose period, prior to taper down, to measure change from baseline ]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.
- The Smell Catastrophizing Scale (SCS) [ Time Frame: Baseline and Week 12 after completion of fixed-dose period, prior to taper down, to measure change from baseline ]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.
- 36-Item Short Form Health Survey (SF-36) [ Time Frame: Baseline and Week 12 after completion of fixed-dose period, prior to taper down, to measure change from baseline ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05216614
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Jay F Piccirillo, MD||Washington University School of Medicine|