Fluoxetine to Reduce Hospitalization From COVID-19 Infection (FloR COVID-19)
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|ClinicalTrials.gov Identifier: NCT04570449|
Recruitment Status : Withdrawn (Study timeline is not feasible)
First Posted : September 30, 2020
Last Update Posted : December 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Drug: Fluoxetine Drug: Placebo||Early Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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)
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
fluoxetine placebo capsule
- Rate of hospitalization [ Time Frame: 8 weeks ]Measures number of subjects hospitalized for COVID-19 symptoms
- 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).
- Rate of intubation [ Time Frame: 8 weeks ]Measures number of subjects intubated for COVID-19 symptoms
- Rate of death [ Time Frame: 8 weeks ]Measures number of subjects who die from COVID-19 symptoms
- 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.
- 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.
- 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.
- 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.
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
|United States, Pennsylvania|
|Milton S. Hershey Medical Center Clinical Research Center|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Erika Saunders, MD||Milton S. Hershey Medical Center|