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This project will test the efficacy of fluoxetine to prevent serious consequences of COVID-19 infection, especially death. Becoming sick with COVID-19 virus or any other serious respiratory condition is not fun. However, the dramatic effects of the COVID-19 pandemic on human society stem from its significant mortality, not the number of individuals who become sick. This project aims to prevent serious outcomes such as hospitalization, respiratory failure and death during the time it takes to develop vaccinations and other strategies to prevent COVID-19 infectionPoor outcomes with COVID-19 infection such as hospitalization, respiratory failure, organ failure and death are associated with a dysfunctional exaggerated immune response, called a cytokine storm, that is triggered by Interleukin-6 expression (IL-6) and seems to occur around day 5 to 7 of symptoms. Fluoxetine has extraordinarily strong evidence in its action as a blocker of IL-6 and cytokine storms in both animal models of infection and in human illness such as rheumatoid arthritis and others. This action of fluoxetine is an entirely separate pathway than the serotonergic pathway that allows fluoxetine to act as an antidepressant. This pathway has been demonstrated in cell culture, in animal models, in human illness and by novel bioinformatics analyses of protein transcripts to be relatively unique for fluoxetine and appears to be a novel pathway. This project aims to inhibit the increase in IL-6 expression and thereby prevent the cytokine storm that causes poor outcomes. Patients who have tested positive or are presumptively positive for COVID-19 will be entered into the study and given the option to start the medication fluoxetine, which is demonstrated to prevent IL-6 surges in infectious and inflammatory conditions. Participants will be monitored daily for COVID-19 symptoms and weekly for side effects and tolerance of fluoxetine. A subset of patients will have blood drawn weekly and stored to monitor IL-6 and other cytokine levels at a later date.
This project aims to reduce the serious outcomes of COVID-19 infection by preventing or inhibiting the cytokine storm associated with organ failure, respiratory failure and death.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment As Usual | No Intervention | Participants may choose to not take fluoxetine and remain in the study | |
| Fluoxetine | Active Comparator | Participants will take fluoxetine 20 mg initially, increasing as tolerated to a maximum of 60 mg until symptoms abate, then will be tapered by 20 mg per week off the fluoxetine Participants will be on fluoxetine for 2 weeks to 2 months depending on symptom duration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoxetine | Drug | Fluoxetine 20 mg to 60 mg daily given from 2 weeks to 2 months duration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Outpatient Subject Hospitalizations | whether the subject is hospitalized for COVID-19 symptoms | 2 months |
| Number of Subjects Undergoing Intubation | whether the subject is intubated for COVID-19 symptoms | 2 months |
| Number of Patients Who Died Within 2 Months of Entry Into the Study | Patients who died from any cause within 2 months of entry into the study. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With 1 or More Symptom Free Day With no COVID Primary Symptoms During 2 Months After Study Entry | Participant who achieved remission from covid with no active covid symptoms (cough, fever, shortness of breath, fatigue, muscle aches, and loss of taste and smell) from study entry | 2 months |
| Participants With Patient Health Questionnaire (PHQ) -9 Score Below 10 After Baseline Assessment |
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Inclusion Criteria:
Overall Study Exclusion Criteria :
Exclusion from Fluoxetine Arm:
Exclusion from Blood Sample Provision:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Toledo | Toledo | Ohio | 43614 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment As Usual | Participants may choose to not take fluoxetine and remain in the study |
| FG001 | Fluoxetine | Participants will take fluoxetine 20 mg initially, increasing as tolerated to a maximum of 60 mg until symptoms abate, then will be tapered by 20 mg per week off the fluoxetine Participants will be on fluoxetine for 2 weeks to 2 months depending on symptom duration Fluoxetine: Fluoxetine 20 mg to 60 mg daily given from 2 weeks to 2 months duration |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment As Usual | Participants may choose to not take fluoxetine and remain in the study |
| BG001 | Fluoxetine | Participants will take fluoxetine 20 mg initially, increasing as tolerated to a maximum of 60 mg until symptoms abate, then will be tapered by 20 mg per week off the fluoxetine Participants will be on fluoxetine for 2 weeks to 2 months depending on symptom duration Fluoxetine: Fluoxetine 20 mg to 60 mg daily given from 2 weeks to 2 months duration |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Outpatient Subject Hospitalizations | whether the subject is hospitalized for COVID-19 symptoms | We had intended this measure for outpatients but had very few study participants who were outpatients. | Posted | Count of Participants | Participants | 2 months |
|
Adverse event data was collected over up to 2 months from when each participant was enrolled by the study team.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment As Usual | Participants may choose to not take fluoxetine and remain in the study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Patient went in to acute respiratory failure secondary to COVID-19 PNA, coded, was emergently intubated and died after attempts to resuscitate. Patient was in the control arm of the study and did not receive the study drug. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cheryl McCullumsmith, M.D., Ph.D. | The University of Toledo Department of Psychiatry | 419-383-5669 | cheryl.mccullumsmith@utoledo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 2, 2020 | Sep 17, 2022 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000080424 | Cytokine Release Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D005473 | Fluoxetine |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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All patients who enter the study will be monitored daily for symptoms of COVID-19. Patients may choose to take fluoxetine or to have treatment as usual. Patients may also choose to have blood drawn and stored for a future analysis of cytokines.
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depression score rating from 0 to 27 where higher scores indicate worse depression Scores of 10 or more meet criteria for diagnosis as a mild depressive episode |
| 2 months |
| Participants With Generalized Anxiety Disorder (GAD) -7 Scale Score Below 10 After Baseline Assessment | anxiety scale with scores ranging from 0 to 21 where higher scores indicate more severe anxiety Scores of 10 or more generally indicate anxiety that might meet criteria for diagnosis as an anxiety disorder | 2 months |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Smoke Cigarettes | Count of Participants | Participants |
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| Primary | Number of Subjects Undergoing Intubation | whether the subject is intubated for COVID-19 symptoms | Posted | Count of Participants | Participants | 2 months |
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| Primary | Number of Patients Who Died Within 2 Months of Entry Into the Study | Patients who died from any cause within 2 months of entry into the study. | review of charts to determine death by any cause within 2 months of entry into study | Posted | Count of Participants | Participants | 2 months |
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| Secondary | Participants With 1 or More Symptom Free Day With no COVID Primary Symptoms During 2 Months After Study Entry | Participant who achieved remission from covid with no active covid symptoms (cough, fever, shortness of breath, fatigue, muscle aches, and loss of taste and smell) from study entry | Posted | Count of Participants | Participants | 2 months |
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|
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| Secondary | Participants With Patient Health Questionnaire (PHQ) -9 Score Below 10 After Baseline Assessment | depression score rating from 0 to 27 where higher scores indicate worse depression Scores of 10 or more meet criteria for diagnosis as a mild depressive episode | Posted | Count of Participants | Participants | 2 months |
|
|
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| Secondary | Participants With Generalized Anxiety Disorder (GAD) -7 Scale Score Below 10 After Baseline Assessment | anxiety scale with scores ranging from 0 to 21 where higher scores indicate more severe anxiety Scores of 10 or more generally indicate anxiety that might meet criteria for diagnosis as an anxiety disorder | Posted | Count of Participants | Participants | 2 months |
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| 1 |
| 4 |
| 1 |
| 4 |
| 0 |
| 4 |
| EG001 | Fluoxetine | Participants will take fluoxetine 20 mg initially, increasing as tolerated to a maximum of 60 mg until symptoms abate, then will be tapered by 20 mg per week off the fluoxetine Participants will be on fluoxetine for 2 weeks to 2 months depending on symptom duration Fluoxetine: Fluoxetine 20 mg to 60 mg daily given from 2 weeks to 2 months duration | 0 | 11 | 0 | 11 | 0 | 11 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |