Fluoxetine to Reduce Hospitalization From COVID-19 Infection (FloR COVID-19)
NCT ID: NCT04570449
Last Updated: 2020-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
EARLY_PHASE1
INTERVENTIONAL
2020-11-30
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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)
Fluoxetine
20 mg capsule
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
Placebo
fluoxetine placebo capsule
Interventions
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Fluoxetine
20 mg capsule
Placebo
fluoxetine placebo capsule
Eligibility Criteria
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Inclusion Criteria
2. 18 years of age or older
3. able to give informed consent
4. Tested positive for active SARS-CoV-2 infection and
1. It's been less than 10 days since symptoms first appeared;
2. Fever persists for longer than 24 hours without the use of fever reducing medications; and
3. Experiencing other symptoms of COVID-19 as described by the CDC
Exclusion Criteria
2. Unable to give informed consent
3. Less than 18 years of age
4. Hospitalization
5. Active bleeding requiring blood products in past week
6. Diagnosed with bipolar disorder and not on mood stabilizing medication
7. Known allergy or hypersensitivity to fluoxetine
8. Currently taking a monoamine oxidase inhibitor (MAOI)
9. Currently taking an selective serotonin reuptake inhibitor (SSRI) or selective norepinephrine reuptake inhibitor (SNRI)
10. Outpatient and currently taking hydroxychloroquine
11. Known pregnancy
12. Breastfeeding
13. Known prolonged QTc, such as congenital prolonged QTc syndromes
18 Years
ALL
No
Sponsors
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Milton S. Hershey Medical Center
OTHER
Responsible Party
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Erika Saunders
Hershey Medical Center Manager
Principal Investigators
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Erika Saunders, MD
Role: PRINCIPAL_INVESTIGATOR
Milton S. Hershey Medical Center
Locations
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Milton S. Hershey Medical Center Clinical Research Center
Hershey, Pennsylvania, United States
Countries
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References
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Other Identifiers
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00015598
Identifier Type: -
Identifier Source: org_study_id