Fluoxetine to Reduce Hospitalization From COVID-19 Infection (FloR COVID-19)

Purpose

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

  • Covid19

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. English speaking participant 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

  1. Prisoner or institutionalized patient 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

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT04570449
Status
Withdrawn
Sponsor
Milton S. Hershey Medical Center

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.