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.
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.
Drug: Fluoxetine
20 mg capsule
Drug: Placebo
fluoxetine placebo capsule
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
Milton S. Hershey Medical Center Clinical Research Center
Hershey, Pennsylvania, United States
Erika Saunders, MD, Principal Investigator
Milton S. Hershey Medical Center