Covid19
Conditions
Keywords
covid-19, fluoxetine, cytokine, anti-inflammatory, IL-6
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.
Interventions
DRUGFluoxetine
20 mg capsule
DRUGPlacebo
fluoxetine placebo capsule
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Rate of intubation | 8 weeks | Measures number of subjects intubated for COVID-19 symptoms |
| 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. |
| 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. |
| Rate of death | 8 weeks | Measures number of subjects who die from COVID-19 symptoms |
Countries
United States
Outcome results
None listed