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

Penn State Health

Status and phase: Withdrawn; Early Phase 1

Conditions: Covid19

Treatments: Drug: Placebo; Drug: Fluoxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT04570449

00015598

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Fluoxetine

Experimental group

Description:

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)

Treatment:

Drug: Fluoxetine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo