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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04570449
Recruitment Status : Withdrawn (Study timeline is not feasible)
First Posted : September 30, 2020
Last Update Posted : December 24, 2020
Sponsor:
Information provided by (Responsible Party):
Erika Saunders, Milton S. Hershey Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Fluoxetine Drug: Placebo Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fluoxetine to Reduce Hospitalization From COVID-19 Infection (FloR COVID-19)
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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)

 Drug: Fluoxetine
20 mg capsule
Placebo Comparator: 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

 Drug: Placebo
fluoxetine placebo capsule


Outcome Measures
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Primary Outcome Measures :
  1. Rate of hospitalization [ Time Frame: 8 weeks ]
    Measures number of subjects hospitalized for COVID-19 symptoms

  2. Physical symptoms assessed through daily checklist [ Time Frame: 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 :
  1. Rate of intubation [ Time Frame: 8 weeks ]
    Measures number of subjects intubated for COVID-19 symptoms

  2. Rate of death [ Time Frame: 8 weeks ]
    Measures number of subjects who die from COVID-19 symptoms

  3. Depressive symptoms assessed weekly [ Time Frame: 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.

  4. Post traumatic stress disorder symptoms assessed weekly [ Time Frame: 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.

  5. Anxiety symptoms assessed weekly [ Time Frame: 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.

  6. Suicidality assessed daily [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04570449


Locations
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United States, Pennsylvania
Milton S. Hershey Medical Center Clinical Research Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Erika Saunders, MD Milton S. Hershey Medical Center
More Information
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Publications:

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Responsible Party: Erika Saunders, Hershey Medical Center Manager, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT04570449    
Other Study ID Numbers: 00015598
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: December 24, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erika Saunders, Milton S. Hershey Medical Center:
covid-19
fluoxetine
cytokine
anti-inflammatory
IL-6
Additional relevant MeSH terms:
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COVID-19
Infections
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Fluoxetine
 Selective Serotonin Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors