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临床试验/NCT04377308
NCT04377308已完成4 期

Fluoxetine to Reduce Intubation and Death After COVID19 Infection

University of Toledo Health Science Campus1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2020年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
16
试验地点
1
主要终点
Number of Outpatient Subject Hospitalizations

研究概览

简要总结

This project will test the efficacy of fluoxetine to prevent serious consequences of COVID-19 infection, especially death. Becoming sick with COVID-19 virus or any other serious respiratory condition is not fun. However, the dramatic effects of the COVID-19 pandemic on human society stem from its significant mortality, not the number of individuals who become sick. This project aims to prevent serious outcomes such as hospitalization, respiratory failure and death during the time it takes to develop vaccinations and other strategies to prevent COVID-19 infectionPoor outcomes with COVID-19 infection such as hospitalization, respiratory failure, organ failure and death are associated with a dysfunctional exaggerated immune response, called a cytokine storm, that is triggered by Interleukin-6 expression (IL-6) and seems to occur around day 5 to 7 of symptoms. Fluoxetine has extraordinarily strong evidence in its action as a blocker of IL-6 and cytokine storms in both animal models of infection and in human illness such as rheumatoid arthritis and others. This action of fluoxetine is an entirely separate pathway than the serotonergic pathway that allows fluoxetine to act as an antidepressant. This pathway has been demonstrated in cell culture, in animal models, in human illness and by novel bioinformatics analyses of protein transcripts to be relatively unique for fluoxetine and appears to be a novel pathway. This project aims to inhibit the increase in IL-6 expression and thereby prevent the cytokine storm that causes poor outcomes. Patients who have tested positive or are presumptively positive for COVID-19 will be entered into the study and given the option to start the medication fluoxetine, which is demonstrated to prevent IL-6 surges in infectious and inflammatory conditions. Participants will be monitored daily for COVID-19 symptoms and weekly for side effects and tolerance of fluoxetine. A subset of patients will have blood drawn weekly and stored to monitor IL-6 and other cytokine levels at a later date.

This project aims to reduce the serious outcomes of COVID-19 infection by preventing or inhibiting the cytokine storm associated with organ failure, respiratory failure and death.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 and above, able to give informed consent or with legally authorized representative
  • COVID-19 test positive or presumptive positive awaiting COVID testing or results by following criteria: fever, cough and shortness of breath or presumptive positive by one of these 3 criteria (fever, cough or shortness of breath) and known exposure to COVID-19 positive individual in past 2 weeks
  • Overall Study Exclusion Criteria :
  • Unable to give informed consent and no legal representativ
  • Prisoner/ institutionalized patient
  • Under age 18
  • Exclusion from Fluoxetine Arm:
  • Active bleeding requiring blood products
  • Bipolar disorder not on mood stabilizing medication*
  • Known allergy or hypersensitivity to fluoxetine
  • Currently taking the following medications : MAO I, pimozide, thioridine
  • Currently taking hydroxychloroquine
  • Pregnant or breastfeeding
  • For hospitalized patients : QTc greater than 500 ms
  • *Hospitalized patient may be on hydroxychloroquine if QTc<500 and the primary attending approves
  • Exclusion from Blood Sample Provision:
  • Self-report of under 110 pounds

排除标准

  • 未提供

研究组 & 干预措施

Fluoxetine

Active Comparator

Participants will take fluoxetine 20 mg initially, increasing as tolerated to a maximum of 60 mg until symptoms abate, then will be tapered by 20 mg per week off the fluoxetine Participants will be on fluoxetine for 2 weeks to 2 months depending on symptom duration

干预措施: Fluoxetine (Drug)

结局指标

主要结局

Number of Outpatient Subject Hospitalizations

时间窗: 2 months

whether the subject is hospitalized for COVID-19 symptoms

Number of Patients Who Died Within 2 Months of Entry Into the Study

时间窗: 2 months

Patients who died from any cause within 2 months of entry into the study.

Number of Subjects Undergoing Intubation

时间窗: 2 months

whether the subject is intubated for COVID-19 symptoms

次要结局

  • Participants With Generalized Anxiety Disorder (GAD) -7 Scale Score Below 10 After Baseline Assessment(2 months)
  • Participants With 1 or More Symptom Free Day With no COVID Primary Symptoms During 2 Months After Study Entry(2 months)
  • Participants With Patient Health Questionnaire (PHQ) -9 Score Below 10 After Baseline Assessment(2 months)

研究者

发起方
University of Toledo Health Science Campus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cheryl Mccullumsmith

Professor and Chair, Department of Psychiatry

University of Toledo Health Science Campus

研究点 (1)

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