Back to resultsFluoxetine to Reduce Hospitalization From COVID-19 Infection (FloR COVID-19)
Primary Purpose
Covid19
Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fluoxetine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring covid-19, fluoxetine, cytokine, anti-inflammatory, IL-6
Eligibility Criteria
Inclusion Criteria:
- English speaking participant
- 18 years of age or older
- able to give informed consent
Tested positive for active SARS-CoV-2 infection and
- It's been less than 10 days since symptoms first appeared;
- Fever persists for longer than 24 hours without the use of fever reducing medications; and
- Experiencing other symptoms of COVID-19 as described by the CDC
Exclusion Criteria:
- Prisoner or institutionalized patient
- Unable to give informed consent
- Less than 18 years of age
- Hospitalization
- Active bleeding requiring blood products in past week
- Diagnosed with bipolar disorder and not on mood stabilizing medication
- Known allergy or hypersensitivity to fluoxetine
- Currently taking a monoamine oxidase inhibitor (MAOI)
- Currently taking an selective serotonin reuptake inhibitor (SSRI) or selective norepinephrine reuptake inhibitor (SNRI)
- Outpatient and currently taking hydroxychloroquine
- Known pregnancy
- Breastfeeding
- Known prolonged QTc, such as congenital prolonged QTc syndromes
Sites / Locations
- Milton S. Hershey Medical Center Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fluoxetine
Placebo
Arm Description
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)
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
Outcomes
Primary Outcome Measures
Rate of hospitalization
Measures number of subjects hospitalized for COVID-19 symptoms
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).
Secondary Outcome Measures
Rate of intubation
Measures number of subjects intubated for COVID-19 symptoms
Rate of death
Measures number of subjects who die from COVID-19 symptoms
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.
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.
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.
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.
Full Information
NCT ID
NCT04570449
First Posted
September 29, 2020
Last Updated
December 22, 2020
Sponsor
Milton S. Hershey Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04570449
Brief Title
Fluoxetine to Reduce Hospitalization From COVID-19 Infection (FloR COVID-19)
Official Title
Fluoxetine to Reduce Hospitalization From COVID-19 Infection (FloR COVID-19)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Study timeline is not feasible
Study Start Date
November 2020 (Anticipated)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
covid-19, fluoxetine, cytokine, anti-inflammatory, IL-6
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluoxetine
Arm Type
Experimental
Arm Description
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)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Intervention Description
20 mg capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
fluoxetine placebo capsule
Primary Outcome Measure Information:
Title
Rate of hospitalization
Description
Measures number of subjects hospitalized for COVID-19 symptoms
Time Frame
8 weeks
Title
Physical symptoms assessed through daily checklist
Description
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).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Rate of intubation
Description
Measures number of subjects intubated for COVID-19 symptoms
Time Frame
8 weeks
Title
Rate of death
Description
Measures number of subjects who die from COVID-19 symptoms
Time Frame
8 weeks
Title
Depressive symptoms assessed weekly
Description
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.
Time Frame
8 weeks
Title
Post traumatic stress disorder symptoms assessed weekly
Description
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.
Time Frame
8 weeks
Title
Anxiety symptoms assessed weekly
Description
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.
Time Frame
8 weeks
Title
Suicidality assessed daily
Description
Measured using the 6-item Columbia-Suicide Severity Rating Scale (C-SSRS), a semi-structured interview on the presence or absence of suicidal ideation.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
English speaking participant
18 years of age or older
able to give informed consent
Tested positive for active SARS-CoV-2 infection and
It's been less than 10 days since symptoms first appeared;
Fever persists for longer than 24 hours without the use of fever reducing medications; and
Experiencing other symptoms of COVID-19 as described by the CDC
Exclusion Criteria:
Prisoner or institutionalized patient
Unable to give informed consent
Less than 18 years of age
Hospitalization
Active bleeding requiring blood products in past week
Diagnosed with bipolar disorder and not on mood stabilizing medication
Known allergy or hypersensitivity to fluoxetine
Currently taking a monoamine oxidase inhibitor (MAOI)
Currently taking an selective serotonin reuptake inhibitor (SSRI) or selective norepinephrine reuptake inhibitor (SNRI)
Outpatient and currently taking hydroxychloroquine
Known pregnancy
Breastfeeding
Known prolonged QTc, such as congenital prolonged QTc syndromes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erika Saunders, MD
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Milton S. Hershey Medical Center Clinical Research Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
12. IPD Sharing Statement
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Fluoxetine to Reduce Hospitalization From COVID-19 Infection (FloR COVID-19)
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