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

• Status: Withdrawn
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Milton S. Hershey Medical Center
• Treatments: Fluoxetine

Criteria

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