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

Early Phase 1

Withdrawn

• Conditions: Covid19
• Interventions: Drug: Placebo; Drug: Fluoxetine

• Registration Number: NCT04570449
• Lead Sponsor: Milton S. Hershey Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2020-09-29
• Study First Submitted QC: 2020-09-29
• Study First Posted: 2020-09-30
• Study Start: 2020-11
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-22
• Last Update Posted: 2020-12-24
• Primary Completion: 2021-11
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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
Fluoxetine	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)

Primary Outcome Measures

Name	Time	Method
Rate of hospitalization	8 weeks	Measures number of subjects hospitalized for COVID-19 symptoms
Physical symptoms assessed through daily checklist	8 weeks	The 23-item daily symptom checklist measures the presence or absence of COVID-related symptoms (e.g. shortness of breath, fever, chills) and other possible symptoms (e.g. ear pain, vomit, seizures).

Secondary Outcome Measures

Name	Time	Method
Rate of intubation	8 weeks	Measures number of subjects intubated for COVID-19 symptoms
Rate of death	8 weeks	Measures number of subjects who die from COVID-19 symptoms
Depressive symptoms assessed weekly	8 weeks	Measured using the 9-item Patient Health Questionnaire (PHQ-9) each item rated on a scale of 0-3, where 0=no depressive symptoms and 3=depressive symptoms present nearly every day. A high score indicates severe depression.
Post traumatic stress disorder symptoms assessed weekly	8 weeks	Measured using the 4-item SPAN assessment rated on a scale from 0-4 where 0=not at all distressing and 4=extremely distressing. A score greater than 5 indicates the presence of PTSD.
Anxiety symptoms assessed weekly	8 weeks	Measured using the 7-item General Anxiety Disorder Scale (GAD-7) rated from 0-3, where 0=no anxiety symptoms and 3=anxiety symptoms present nearly ever day. A high score indicates severe anxiety.
Suicidality assessed daily	8 weeks	Measured using the 6-item Columbia-Suicide Severity Rating Scale (C-SSRS), a semi-structured interview on the presence or absence of suicidal ideation.

Trial Locations

Locations (1)

Milton S. Hershey Medical Center Clinical Research Center; 🇺🇸 Hershey, Pennsylvania, United States