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Fluoxetine to Reduce Intubation and Death After COVID19 Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04377308
Recruitment Status : Completed
First Posted : May 6, 2020
Results First Posted : September 30, 2022
Last Update Posted : September 30, 2022
Sponsor:
Information provided by (Responsible Party):
Cheryl Mccullumsmith, University of Toledo Health Science Campus

Tracking Information
First Submitted Date  ICMJE April 18, 2020
First Posted Date  ICMJE May 6, 2020
Results First Submitted Date  ICMJE March 4, 2022
Results First Posted Date  ICMJE September 30, 2022
Last Update Posted Date September 30, 2022
Actual Study Start Date  ICMJE May 1, 2020
Actual Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2022)
  • Number of Outpatient Subject Hospitalizations [ Time Frame: 2 months ]
    whether the subject is hospitalized for COVID-19 symptoms
  • Number of Subjects Undergoing Intubation [ Time Frame: 2 months ]
    whether the subject is intubated for COVID-19 symptoms
  • Number of Patients Who Died Within 2 Months of Entry Into the Study [ Time Frame: 2 months ]
    Patients who died from any cause within 2 months of entry into the study.
Original Primary Outcome Measures  ICMJE
 (submitted: May 4, 2020)
  • Hospitalizations [ Time Frame: 2 months ]
    whether the subject is hospitalized for COVID-19 symptoms
  • Intubation [ Time Frame: 2 months ]
    whether the subject is intubated for COVID-19 symptoms
  • Death [ Time Frame: 2 months ]
    whether the subject dies of COVID-19 symptoms
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2022)
  • Participants With 1 or More Symptom Free Day With no COVID Primary Symptoms During 2 Months After Study Entry [ Time Frame: 2 months ]
    Participant who achieved remission from covid with no active covid symptoms (cough, fever, shortness of breath, fatigue, muscle aches, and loss of taste and smell) from study entry
  • Participants With Patient Health Questionnaire (PHQ) -9 Score Below 10 After Baseline Assessment [ Time Frame: 2 months ]
    depression score rating from 0 to 27 where higher scores indicate worse depression Scores of 10 or more meet criteria for diagnosis as a mild depressive episode
  • Participants With Generalized Anxiety Disorder (GAD) -7 Scale Score Below 10 After Baseline Assessment [ Time Frame: 2 months ]
    anxiety scale with scores ranging from 0 to 21 where higher scores indicate more severe anxiety Scores of 10 or more generally indicate anxiety that might meet criteria for diagnosis as an anxiety disorder
Original Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2020)
  • Number of days of illness [ Time Frame: 2 months ]
  • PHQ-9 score for depressive symptoms, [ Time Frame: 2 months ]
    depression
  • generalized anxiety Disorder-7 scale [ Time Frame: 2 months ]
    anxiety
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fluoxetine to Reduce Intubation and Death After COVID19 Infection
Official Title  ICMJE Fluoxetine to Reduce Intubation and Death After COVID19 Infection
Brief Summary

This project will test the efficacy of fluoxetine to prevent serious consequences of COVID-19 infection, especially death. Becoming sick with COVID-19 virus or any other serious respiratory condition is not fun. However, the dramatic effects of the COVID-19 pandemic on human society stem from its significant mortality, not the number of individuals who become sick. This project aims to prevent serious outcomes such as hospitalization, respiratory failure and death during the time it takes to develop vaccinations and other strategies to prevent COVID-19 infectionPoor outcomes with COVID-19 infection such as hospitalization, respiratory failure, organ failure and death are associated with a dysfunctional exaggerated immune response, called a cytokine storm, that is triggered by Interleukin-6 expression (IL-6) and seems to occur around day 5 to 7 of symptoms. Fluoxetine has extraordinarily strong evidence in its action as a blocker of IL-6 and cytokine storms in both animal models of infection and in human illness such as rheumatoid arthritis and others. This action of fluoxetine is an entirely separate pathway than the serotonergic pathway that allows fluoxetine to act as an antidepressant. This pathway has been demonstrated in cell culture, in animal models, in human illness and by novel bioinformatics analyses of protein transcripts to be relatively unique for fluoxetine and appears to be a novel pathway. This project aims to inhibit the increase in IL-6 expression and thereby prevent the cytokine storm that causes poor outcomes. Patients who have tested positive or are presumptively positive for COVID-19 will be entered into the study and given the option to start the medication fluoxetine, which is demonstrated to prevent IL-6 surges in infectious and inflammatory conditions. Participants will be monitored daily for COVID-19 symptoms and weekly for side effects and tolerance of fluoxetine. A subset of patients will have blood drawn weekly and stored to monitor IL-6 and other cytokine levels at a later date.

This project aims to reduce the serious outcomes of COVID-19 infection by preventing or inhibiting the cytokine storm associated with organ failure, respiratory failure and death.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
All patients who enter the study will be monitored daily for symptoms of COVID-19. Patients may choose to take fluoxetine or to have treatment as usual. Patients may also choose to have blood drawn and stored for a future analysis of cytokines.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID-19
  • Cytokine Storm
Intervention  ICMJE Drug: Fluoxetine
Fluoxetine 20 mg to 60 mg daily given from 2 weeks to 2 months duration
Other Name: prozac
Study Arms  ICMJE
  • No Intervention: Treatment As Usual
    Participants may choose to not take fluoxetine and remain in the study
  • Active Comparator: Fluoxetine
    Participants will take fluoxetine 20 mg initially, increasing as tolerated to a maximum of 60 mg until symptoms abate, then will be tapered by 20 mg per week off the fluoxetine Participants will be on fluoxetine for 2 weeks to 2 months depending on symptom duration
    Intervention: Drug: Fluoxetine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2022)
16
Original Estimated Enrollment  ICMJE
 (submitted: May 4, 2020)
2000
Actual Study Completion Date  ICMJE April 30, 2021
Actual Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients aged 18 and above, able to give informed consent or with legally authorized representative
  • COVID-19 test positive or presumptive positive awaiting COVID testing or results by following criteria: fever, cough and shortness of breath or presumptive positive by one of these 3 criteria (fever, cough or shortness of breath) and known exposure to COVID-19 positive individual in past 2 weeks

Overall Study Exclusion Criteria :

  • Unable to give informed consent and no legal representativ
  • Prisoner/ institutionalized patient
  • Under age 18

Exclusion from Fluoxetine Arm:

  • Active bleeding requiring blood products
  • Bipolar disorder not on mood stabilizing medication*
  • Known allergy or hypersensitivity to fluoxetine
  • Currently taking the following medications : MAO I, pimozide, thioridine
  • Currently taking hydroxychloroquine
  • Pregnant or breastfeeding
  • For hospitalized patients : QTc greater than 500 ms
  • *Hospitalized patient may be on hydroxychloroquine if QTc<500 and the primary attending approves

Exclusion from Blood Sample Provision:

  • Pregnant
  • Self-report of under 110 pounds
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04377308
Other Study ID Numbers  ICMJE FRIDA COVID19
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Cheryl Mccullumsmith, University of Toledo Health Science Campus
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Toledo Health Science Campus
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Toledo
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP