Fluoxetine to Reduce Intubation and Death After COVID19 Infection

COVID-19 Clinical Trial

Official title:

Fluoxetine to Reduce Intubation and Death After COVID19 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04377308
• Other study ID #: FRIDA COVID19
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: September 2022
• Source: University of Toledo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Cytokine Release Syndrome
• Cytokine Storm

Intervention

Drug:
• Fluoxetine
Fluoxetine 20 mg to 60 mg daily given from 2 weeks to 2 months duration

Locations

Country	Name	City	State
United States	University of Toledo	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Toledo Health Science Campus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Outpatient Subject Hospitalizations	whether the subject is hospitalized for COVID-19 symptoms	2 months
Primary	Number of Subjects Undergoing Intubation	whether the subject is intubated for COVID-19 symptoms	2 months
Primary	Number of Patients Who Died Within 2 Months of Entry Into the Study	Patients who died from any cause within 2 months of entry into the study.	2 months
Secondary	Participants With 1 or More Symptom Free Day With no COVID Primary Symptoms During 2 Months After Study Entry	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 months
Secondary	Participants With Patient Health Questionnaire (PHQ) -9 Score Below 10 After Baseline Assessment	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	2 months
Secondary	Participants With Generalized Anxiety Disorder (GAD) -7 Scale Score Below 10 After Baseline Assessment	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	2 months