Fluoxetine to Reduce Hospitalization From COVID-19 Infection (FloR COVID-19)
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Rate of hospitalization
研究概览
简要总结
The current research is a pilot study to determine the feasibility of recruiting and retaining 40 participants diagnosed with COVID-19. The purpose is to observe the early use of fluoxetine (commonly known as Prozac) to reduce the severity of the COVID-19 illness. Fluoxetine is a drug that has been approved by the U.S. Food and Drug Administration (FDA) since 1987 for various mental health disorders.
详细描述
Morbidity and mortality resulting from COVID-19 infections are associated with multisystem organ failure due to a rapid increase in cytokine production. Fluoxetine has been shown to reduce the mechanisms that cause the cytokine storm that leads to COVID-19 fatalities.
This is a pilot study to assess feasibility of recruiting and retaining participants diagnosed with COVID-19. The purpose of this study is to observe the early use of fluoxetine treatments on illness outcome: primary outcome is hospitalization and secondary outcomes of complications including intubation and death. Additional secondary outcomes include effects on outcomes for depression and post-traumatic stress disorder, two common illnesses which may be improved by fluoxetine.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking participant
- •18 years of age or older
- •able to give informed consent
- •Tested positive for active SARS-CoV-2 infection and
- •It's been less than 10 days since symptoms first appeared;
- •Fever persists for longer than 24 hours without the use of fever reducing medications; and
- •Experiencing other symptoms of COVID-19 as described by the CDC
排除标准
- •Prisoner or institutionalized patient
- •Unable to give informed consent
- •Less than 18 years of age
- •Hospitalization
- •Active bleeding requiring blood products in past week
- •Diagnosed with bipolar disorder and not on mood stabilizing medication
- •Known allergy or hypersensitivity to fluoxetine
- •Currently taking a monoamine oxidase inhibitor (MAOI)
- •Currently taking an selective serotonin reuptake inhibitor (SSRI) or selective norepinephrine reuptake inhibitor (SNRI)
- •Outpatient and currently taking hydroxychloroquine
- •Known pregnancy
- •Breastfeeding
- •Known prolonged QTc, such as congenital prolonged QTc syndromes
研究组 & 干预措施
Fluoxetine
Participants instructed to take fluoxetine 20 mg capsule orally daily for 8 weeks in the following schedule:
Week 1 = 1 pill (20 mg), Week 2 = 2 pills (40 mg), Weeks 3-6 = 3 pills (60 mg), Week 7 = 2 pills (40 mg), Week 8 = pill (20 mg)
干预措施: Fluoxetine (Drug)
Placebo
Participants instructed to take fluoxetine placebo capsule matching fluoxetine orally daily for 8 weeks in the following schedule:
Week 1 = 1 pill, Week 2 = 2 pills, Weeks 3-6 = 3 pills, Week 7 = 2 pills, Week 8 = pill
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of hospitalization
时间窗: 8 weeks
Measures number of subjects hospitalized for COVID-19 symptoms
Physical symptoms assessed through daily checklist
时间窗: 8 weeks
The 23-item daily symptom checklist measures the presence or absence of COVID-related symptoms (e.g. shortness of breath, fever, chills) and other possible symptoms (e.g. ear pain, vomit, seizures).
次要结局
- Rate of death(8 weeks)
- Rate of intubation(8 weeks)
- Depressive symptoms assessed weekly(8 weeks)
- Post traumatic stress disorder symptoms assessed weekly(8 weeks)
- Anxiety symptoms assessed weekly(8 weeks)
- Suicidality assessed daily(8 weeks)
研究者
Erika Saunders
Hershey Medical Center Manager
Milton S. Hershey Medical Center