NCT04570449

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

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Fluoxetine	20 mg capsule
DRUG	Placebo	fluoxetine placebo capsule

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-11-01
• Completion: 2021-12-01
• First posted: 2020-09-30
• Last updated: 2020-12-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study