Fluoxetine to Reduce Intubation and Death After COVID19 Infection

NCT ID: NCT04377308

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2021-04-30

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.

Conditions

COVID-19; Cytokine Storm

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment As Usual

Participants may choose to not take fluoxetine and remain in the study

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: ACTIVE_COMPARATOR

Fluoxetine

Intervention Type: DRUG

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

Interventions

Fluoxetine

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

Intervention Type: DRUG

Other Intervention Names

prozac

Eligibility 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Toledo Health Science Campus

OTHER

Sponsor Role: lead

Responsible Party

Cheryl Mccullumsmith

Professor and Chair, Department of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Toledo

Toledo, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

FRIDA COVID19

Identifier Type: -

Identifier Source: org_study_id