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Covid19Early Phase 1NCT04570449

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

A Early Phase 1 study testing Fluoxetine in people with Covid19, run by Milton S. Hershey Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
What is being tested?
Fluoxetine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
Nov 2020to Dec 2021
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • English speaking participant
  • 18 years of age or older
  • able to give informed consent
  • Tested positive for active SARS-CoV-2 infection and
  • It's been less than 10 days since symptoms first appeared;
  • Fever persists for longer than 24 hours without the use of fever reducing medications; and
  • Experiencing other symptoms of COVID-19 as described by the CDC

Who cannot join

  • Prisoner or institutionalized patient
  • Unable to give informed consent
  • Less than 18 years of age
  • Hospitalization
  • Active bleeding requiring blood products in past week
  • Diagnosed with bipolar disorder and not on mood stabilizing medication
Show all 13Show fewer
  • Known allergy or hypersensitivity to fluoxetine
  • Currently taking a monoamine oxidase inhibitor (MAOI)
  • Currently taking an selective serotonin reuptake inhibitor (SSRI) or selective norepinephrine reuptake inhibitor (SNRI)
  • Outpatient and currently taking hydroxychloroquine
  • Known pregnancy
  • Breastfeeding
  • Known prolonged QTc, such as congenital prolonged QTc syndromes

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Milton S. Hershey Medical Center Clinical Research Center

    Hershey, Pennsylvania, 17033

Other trials in United States

About this study

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.

Read the 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.

Conditions
Covid19
Being tested
Fluoxetine, Placebo
Keywords
covid-19, fluoxetine, cytokine, anti-inflammatory, IL-6
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FluoxetineDrug

    20 mg capsule

  • PlaceboDrug

    fluoxetine placebo capsule

Study groups in NCT04570449
Study groupRoleWhat they receive
FluoxetineExperimentalParticipants 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)
Receives: Drug: Fluoxetine
PlaceboPlacebo comparatorParticipants 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
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of hospitalization

    Measures number of subjects hospitalized for COVID-19 symptoms

    Measured: 8 weeks

  2. 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).

    Measured: 8 weeks

Secondary outcomes (6)

  1. Rate of intubation

    Measures number of subjects intubated for COVID-19 symptoms

    Measured: 8 weeks

  2. Rate of death

    Measures number of subjects who die from COVID-19 symptoms

    Measured: 8 weeks

  3. 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.

    Measured: 8 weeks

  4. 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.

    Measured: 8 weeks

  5. 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.

    Measured: 8 weeks

  6. 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.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2020
  2. Study startNov 2020 (estimated)
  3. Primary completionNov 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Why it stopped: Study timeline is not feasible

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04570449
Sponsor's protocol ID
00015598
Status last verified
Dec 2020
First submitted
29 Sep 2020
Last updated
24 Dec 2020
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 26771135

  • 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.

    PubMed 23145072

  • 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.

    PubMed 26494447

  • 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.

    PubMed 21569123

  • 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.

    PubMed 28477248

  • 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.

    PubMed 26892759

  • 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.

    PubMed 25744603

  • 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.

    PubMed 24613205

  • 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.

    PubMed 17481608

  • 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.

    PubMed 31986264

  • 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.

    PubMed 21217769

  • 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.

    PubMed 21575647

  • 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.

    PubMed 24618100

  • 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.

    PubMed 31932743

  • 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.

    PubMed 17477857

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Fluoxetine in people with Covid19, run by Milton S. Hershey Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of hospitalization (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04570449, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2020.

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