Fluoxetine to Reduce Hospitalization From COVID-19 Infection (FloR COVID-19)

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.

Timeline

Start

2020-11

Primary completion

2021-11

Completion

2021-12

Publications

• 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.
• 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.
• 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.
• Background Branco-de-Almeida LS, Kajiya M, Cardoso CR, Silva MJ, Ohta K, Rosalen PL, Franco GC, Han X, Taubman MA, Kawai T. Selective serotonin reuptake inhibitors attenuate the antigen presentation from dendritic cells to effector T lymphocytes. FEMS Immunol Med Microbiol. 2011 Aug;62(3):283-94. doi: 10.1111/j.1574-695X.2011.00816.x. Epub 2011 Jun 16.
• Background Cai Z, Liu J, Bian H, Cai J, Jin Q, Han J. Fluoxetine, an Antidepressant Drug, Inhibited Cigarette Smoke-Induced Pulmonary Inflammation and Apoptosis in Rats. Inflammation. 2017 Aug;40(4):1375-1381. doi: 10.1007/s10753-017-0580-y.
• Background Dong C, Zhang JC, Yao W, Ren Q, Yang C, Ma M, Han M, Saito R, Hashimoto K. Effects of escitalopram, R-citalopram, and reboxetine on serum levels of tumor necrosis factor-alpha, interleukin-10, and depression-like behavior in mice after lipopolysaccharide administration. Pharmacol Biochem Behav. 2016 May;144:7-12. doi: 10.1016/j.pbb.2016.02.005. Epub 2016 Feb 15.
• Background Durairaj H, Steury MD, Parameswaran N. Paroxetine differentially modulates LPS-induced TNFalpha and IL-6 production in mouse macrophages. Int Immunopharmacol. 2015 Apr;25(2):485-92. doi: 10.1016/j.intimp.2015.02.029. Epub 2015 Mar 2.
• Background Gobin V, Van Steendam K, Denys D, Deforce D. Selective serotonin reuptake inhibitors as a novel class of immunosuppressants. Int Immunopharmacol. 2014 May;20(1):148-56. doi: 10.1016/j.intimp.2014.02.030. Epub 2014 Mar 6.
• 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.
• 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.
• Background Li XQ, Wang HM, Yang CG, Zhang XH, Han DD, Wang HL. Fluoxetine inhibited extracellular matrix of pulmonary artery and inflammation of lungs in monocrotaline-treated rats. Acta Pharmacol Sin. 2011 Feb;32(2):217-22. doi: 10.1038/aps.2010.187. Epub 2011 Jan 10.
• Background Liu D, Wang Z, Liu S, Wang F, Zhao S, Hao A. Anti-inflammatory effects of fluoxetine in lipopolysaccharide(LPS)-stimulated microglial cells. Neuropharmacology. 2011 Sep;61(4):592-9. doi: 10.1016/j.neuropharm.2011.04.033. Epub 2011 May 11.
• 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.
• Background Lu X, Wang J, Chen X, Jiang Y, Pan ZK. Rolipram Protects Mice from Gram-negative Bacterium Escherichia coli-induced Inflammation and Septic Shock. Sci Rep. 2020 Jan 13;10(1):175. doi: 10.1038/s41598-019-56899-6.
• Background Roumestan C, Michel A, Bichon F, Portet K, Detoc M, Henriquet C, Jaffuel D, Mathieu M. Anti-inflammatory properties of desipramine and fluoxetine. Respir Res. 2007 May 3;8(1):35. doi: 10.1186/1465-9921-8-35.
• Background Sherkawy MM, Abo-Youssef AM, Salama AAA, Ismaiel IE. Fluoxetine protects against OVA induced bronchial asthma and depression in rats. Eur J Pharmacol. 2018 Oct 15;837:25-32. doi: 10.1016/j.ejphar.2018.08.026. Epub 2018 Aug 23.
• Background Taraz M, Khatami MR, Dashti-Khavidaki S, Akhonzadeh S, Noorbala AA, Ghaeli P, Taraz S. Sertraline decreases serum level of interleukin-6 (IL-6) in hemodialysis patients with depression: results of a randomized double-blind, placebo-controlled clinical trial. Int Immunopharmacol. 2013 Nov;17(3):917-23. doi: 10.1016/j.intimp.2013.09.020. Epub 2013 Oct 11.
• Background Udina M, Hidalgo D, Navines R, Forns X, Sola R, Farre M, Capuron L, Vieta E, Martin-Santos R. Prophylactic antidepressant treatment of interferon-induced depression in chronic hepatitis C: a systematic review and meta-analysis. J Clin Psychiatry. 2014 Oct;75(10):e1113-21. doi: 10.4088/JCP.13r08800.
• Background Vollmar P, Haghikia A, Dermietzel R, Faustmann PM. Venlafaxine exhibits an anti-inflammatory effect in an inflammatory co-culture model. Int J Neuropsychopharmacol. 2008 Feb;11(1):111-7. doi: 10.1017/S1461145707007729. Epub 2007 Apr 20.
• Background Wang L, Wang R, Liu L, Qiao D, Baldwin DS, Hou R. Effects of SSRIs on peripheral inflammatory markers in patients with major depressive disorder: A systematic review and meta-analysis. Brain Behav Immun. 2019 Jul;79:24-38. doi: 10.1016/j.bbi.2019.02.021. Epub 2019 Feb 21.
• Background Young KC, Bai CH, Su HC, Tsai PJ, Pu CY, Liao CS, Lin YM, Lai HW, Chong LW, Tsai YS, Tsao CW. Fluoxetine a novel anti-hepatitis C virus agent via ROS-, JNK-, and PPARbeta/gamma-dependent pathways. Antiviral Res. 2014 Oct;110:158-67. doi: 10.1016/j.antiviral.2014.08.002. Epub 2014 Aug 21.

Drugs

Indications