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

Sponsor
Milton S. Hershey Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04570449
Collaborator
(none)
0
1
2
13
0

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Fluoxetine to Reduce Hospitalization From COVID-19 Infection (FloR COVID-19)
Anticipated Study Start Date :
Nov 1, 2020
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Rate of hospitalization [8 weeks]

    Measures number of subjects hospitalized for COVID-19 symptoms

  2. Physical symptoms assessed through daily checklist [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).

Secondary Outcome Measures

  1. Rate of intubation [8 weeks]

    Measures number of subjects intubated for COVID-19 symptoms

  2. Rate of death [8 weeks]

    Measures number of subjects who die from COVID-19 symptoms

  3. Depressive symptoms assessed weekly [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.

  4. Post traumatic stress disorder symptoms assessed weekly [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.

  5. Anxiety symptoms assessed weekly [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.

  6. Suicidality assessed daily [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  5. It's been less than 10 days since symptoms first appeared;

  6. Fever persists for longer than 24 hours without the use of fever reducing medications; and

  7. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Milton S. Hershey Medical Center Clinical Research Center Hershey Pennsylvania United States 17033

Sponsors and Collaborators

  • Milton S. Hershey Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Erika Saunders, Hershey Medical Center Manager, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT04570449
Other Study ID Numbers:
  • 00015598
First Posted:
Sep 30, 2020
Last Update Posted:
Dec 24, 2020
Last Verified:
Dec 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Erika Saunders, Hershey Medical Center Manager, Milton S. Hershey Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 24, 2020