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

December 22, 2020 updated by: Erika Saunders, Milton S. Hershey Medical Center
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Milton S. Hershey Medical Center Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. English speaking participant
  2. 18 years of age or older
  3. able to give informed consent

  4. Tested positive for active SARS-CoV-2 infection and

    1. It's been less than 10 days since symptoms first appeared;
    2. Fever persists for longer than 24 hours without the use of fever reducing medications; and
    3. Experiencing other symptoms of COVID-19 as described by the CDC

Exclusion Criteria:

  1. Prisoner or institutionalized patient
  2. Unable to give informed consent
  3. Less than 18 years of age
  4. Hospitalization
  5. Active bleeding requiring blood products in past week
  6. Diagnosed with bipolar disorder and not on mood stabilizing medication
  7. Known allergy or hypersensitivity to fluoxetine
  8. Currently taking a monoamine oxidase inhibitor (MAOI)
  9. Currently taking an selective serotonin reuptake inhibitor (SSRI) or selective norepinephrine reuptake inhibitor (SNRI)
  10. Outpatient and currently taking hydroxychloroquine
  11. Known pregnancy
  12. Breastfeeding
  13. Known prolonged QTc, such as congenital prolonged QTc syndromes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluoxetine

Participants 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)
Drug: Fluoxetine
20 mg capsule
Placebo Comparator: Placebo

Participants 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
Drug: Placebo
fluoxetine placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of hospitalization
Time Frame: 8 weeks
Measures number of subjects hospitalized for COVID-19 symptoms
8 weeks
Physical symptoms assessed through daily checklist
Time Frame: 8 weeks
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).
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of intubation
Time Frame: 8 weeks
Measures number of subjects intubated for COVID-19 symptoms
8 weeks
Rate of death
Time Frame: 8 weeks
Measures number of subjects who die from COVID-19 symptoms
8 weeks
Depressive symptoms assessed weekly
Time Frame: 8 weeks
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.
8 weeks
Post traumatic stress disorder symptoms assessed weekly
Time Frame: 8 weeks
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.
8 weeks
Anxiety symptoms assessed weekly
Time Frame: 8 weeks
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.
8 weeks
Suicidality assessed daily
Time Frame: 8 weeks
Measured using the 6-item Columbia-Suicide Severity Rating Scale (C-SSRS), a semi-structured interview on the presence or absence of suicidal ideation.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Erika Saunders, MD, Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2020

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

September 29, 2020

First Submitted That Met QC Criteria

September 29, 2020

First Posted (Actual)

September 30, 2020

Study Record Updates

Last Update Posted (Actual)

December 24, 2020

Last Update Submitted That Met QC Criteria

December 22, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00015598

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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