We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
COVID-19 Cytokine Storm Drug: Fluoxetine Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
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
Official Title: Fluoxetine to Reduce Intubation and Death After COVID19 Infection
Actual Study Start Date : May 1, 2020
Actual Primary Completion Date : April 30, 2021
Actual Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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
 Drug: Fluoxetine
Fluoxetine 20 mg to 60 mg daily given from 2 weeks to 2 months duration
Other Name: prozac


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of Outpatient Subject Hospitalizations [ Time Frame: 2 months ]
    whether the subject is hospitalized for COVID-19 symptoms

  2. Number of Subjects Undergoing Intubation [ Time Frame: 2 months ]
    whether the subject is intubated for COVID-19 symptoms

  3. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT04377308


Locations
Layout table for location information
United States, Ohio
University of Toledo
Toledo, Ohio, United States, 43614
Sponsors and Collaborators
University of Toledo Health Science Campus
  Study Documents (Full-Text)

Documents provided by Cheryl Mccullumsmith, University of Toledo Health Science Campus:
Study Protocol and Statistical Analysis Plan  [PDF] May 2, 2020

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Cheryl Mccullumsmith, Professor and Chair, Department of Psychiatry, University of Toledo Health Science Campus
ClinicalTrials.gov Identifier: NCT04377308    
Other Study ID Numbers: FRIDA COVID19
First Posted: May 6, 2020    Key Record Dates
Results First Posted: September 30, 2022
Last Update Posted: September 30, 2022
Last Verified: September 2022

Layout table for additional information
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
Keywords provided by Cheryl Mccullumsmith, University of Toledo Health Science Campus:
IL-6
fluoxetine
cytokine storm
NF-KB
COVID-19
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Cytokine Release Syndrome
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Systemic Inflammatory Response Syndrome
Inflammation
 Pathologic Processes
Shock
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors