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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoxetine | Experimental | 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) |
|
| Placebo | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoxetine | Drug | 20 mg capsule |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of hospitalization | Measures number of subjects hospitalized for COVID-19 symptoms | 8 weeks |
| 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). | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of intubation | Measures number of subjects intubated for COVID-19 symptoms | 8 weeks |
| Rate of death | Measures number of subjects who die from COVID-19 symptoms |
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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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erika Saunders, MD | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Milton S. Hershey Medical Center Clinical Research Center | Hershey | Pennsylvania | 17033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26771135 | Background | Amitai M, Taler M, Carmel M, Michaelovsky E, Eilat T, Yablonski M, Orpaz N, Chen A, Apter A, Weizman A, Fennig S. The Relationship Between Plasma Cytokine Levels and Response to Selective Serotonin Reuptake Inhibitor Treatment in Children and Adolescents with Depression and/or Anxiety Disorders. J Child Adolesc Psychopharmacol. 2016 Oct;26(8):727-732. doi: 10.1089/cap.2015.0147. Epub 2016 Jan 15. | |
| 23145072 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Not provided
| ID | Term |
|---|---|
| D005473 | Fluoxetine |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Drug |
fluoxetine placebo capsule |
|
| 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| Background |
| Blatteau JE, Barre S, Pascual A, Castagna O, Abraini JH, Risso JJ, Vallee N. Protective effects of fluoxetine on decompression sickness in mice. PLoS One. 2012;7(11):e49069. doi: 10.1371/journal.pone.0049069. Epub 2012 Nov 8. |
| 26494447 | Background | Blatteau JE, de Maistre S, Lambrechts K, Abraini J, Risso JJ, Vallee N. Fluoxetine stimulates anti-inflammatory IL-10 cytokine production and attenuates sensory deficits in a rat model of decompression sickness. J Appl Physiol (1985). 2015 Dec 15;119(12):1393-9. doi: 10.1152/japplphysiol.00602.2015. Epub 2015 Oct 22. |
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| 17481608 | Background | Hashioka S, Klegeris A, Monji A, Kato T, Sawada M, McGeer PL, Kanba S. Antidepressants inhibit interferon-gamma-induced microglial production of IL-6 and nitric oxide. Exp Neurol. 2007 Jul;206(1):33-42. doi: 10.1016/j.expneurol.2007.03.022. Epub 2007 Mar 30. |
| 31986264 | Background | Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. |
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| 24618100 | Background | Liu RP, Zou M, Wang JY, Zhu JJ, Lai JM, Zhou LL, Chen SF, Zhang X, Zhu JH. Paroxetine ameliorates lipopolysaccharide-induced microglia activation via differential regulation of MAPK signaling. J Neuroinflammation. 2014 Mar 12;11:47. doi: 10.1186/1742-2094-11-47. |
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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 |