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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04570449
• Other study ID #: 00015598
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: November 2020
• Est. completion date: December 2021

Study information

• Verified date: December 2020
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Infection

Intervention

Drug:
• Fluoxetine
20 mg capsule
• Placebo
fluoxetine placebo capsule

Locations

Country	Name	City	State
United States	Milton S. Hershey Medical Center Clinical Research Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (21)

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* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of hospitalization	Measures number of subjects hospitalized for COVID-19 symptoms	8 weeks
Primary	Physical symptoms assessed through daily checklist	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).	8 weeks
Secondary	Rate of intubation	Measures number of subjects intubated for COVID-19 symptoms	8 weeks
Secondary	Rate of death	Measures number of subjects who die from COVID-19 symptoms	8 weeks
Secondary	Depressive symptoms assessed weekly	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.	8 weeks
Secondary	Post traumatic stress disorder symptoms assessed weekly	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.	8 weeks
Secondary	Anxiety symptoms assessed weekly	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.	8 weeks
Secondary	Suicidality assessed daily	Measured using the 6-item Columbia-Suicide Severity Rating Scale (C-SSRS), a semi-structured interview on the presence or absence of suicidal ideation.	8 weeks