Fluoxetine to Reduce Hospitalization From COVID-19 Infection (FloR COVID-19)
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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|
Early Phase 1 |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 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) |
Drug: Fluoxetine
20 mg capsule
|
Placebo Comparator: 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 |
Drug: Placebo
fluoxetine placebo capsule
|
Outcome Measures
Primary Outcome Measures
- Rate of hospitalization [8 weeks]
Measures number of subjects hospitalized for COVID-19 symptoms
- Physical symptoms assessed through daily checklist [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).
Secondary Outcome Measures
- Rate of intubation [8 weeks]
Measures number of subjects intubated for COVID-19 symptoms
- Rate of death [8 weeks]
Measures number of subjects who die from COVID-19 symptoms
- Depressive symptoms assessed weekly [8 weeks]
Measured using the 9-item Patient Health Questionnaire (PHQ-9) each item rated on a scale of 0-3, where 0=no depressive symptoms and 3=depressive symptoms present nearly every day. A high score indicates severe depression.
- Post traumatic stress disorder symptoms assessed weekly [8 weeks]
Measured using the 4-item SPAN assessment rated on a scale from 0-4 where 0=not at all distressing and 4=extremely distressing. A score greater than 5 indicates the presence of PTSD.
- Anxiety symptoms assessed weekly [8 weeks]
Measured using the 7-item General Anxiety Disorder Scale (GAD-7) rated from 0-3, where 0=no anxiety symptoms and 3=anxiety symptoms present nearly ever day. A high score indicates severe anxiety.
- Suicidality assessed daily [8 weeks]
Measured using the 6-item Columbia-Suicide Severity Rating Scale (C-SSRS), a semi-structured interview on the presence or absence of suicidal ideation.
Eligibility Criteria
Criteria
Inclusion Criteria:
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English speaking participant
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18 years of age or older
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able to give informed consent
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Tested positive for active SARS-CoV-2 infection and
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It's been less than 10 days since symptoms first appeared;
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Fever persists for longer than 24 hours without the use of fever reducing medications; and
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Experiencing other symptoms of COVID-19 as described by the CDC
Exclusion Criteria:
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Prisoner or institutionalized patient
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Unable to give informed consent
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Less than 18 years of age
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Hospitalization
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Active bleeding requiring blood products in past week
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Diagnosed with bipolar disorder and not on mood stabilizing medication
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Known allergy or hypersensitivity to fluoxetine
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Currently taking a monoamine oxidase inhibitor (MAOI)
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Currently taking an selective serotonin reuptake inhibitor (SSRI) or selective norepinephrine reuptake inhibitor (SNRI)
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Outpatient and currently taking hydroxychloroquine
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Known pregnancy
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Breastfeeding
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Known prolonged QTc, such as congenital prolonged QTc syndromes
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Milton S. Hershey Medical Center Clinical Research Center | Hershey | Pennsylvania | United States | 17033 |
Sponsors and Collaborators
- Milton S. Hershey Medical Center
Investigators
- Principal Investigator: Erika Saunders, MD, Milton S. Hershey Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
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