Fluvoxamine to Augment Olfactory Recovery For Long COVID-19 Parosmia (FluCOP Trial)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Clinical Global Impression Scale (CGI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Fluvoxamine
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.
干预措施: Fluvoxamine (Drug)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical Global Impression Scale (CGI)
时间窗: 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.
次要结局
- Olfactory Dysfunction Outcomes Rating (ODOR)(Baseline and Week 12 after completion of fixed-dose period, prior to taper down, to measure change from baseline)
- The Smell Catastrophizing Scale (SCS)(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)(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)(Baseline and Week 12 after completion of fixed-dose period, prior to taper down, to measure change from baseline)
- University of Pennsylvania Smell Identification Test (UPSIT)(Baseline and Week 12 after completion of fixed-dose period, prior to taper down, to measure change from baseline)