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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 Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions COVID-19
Cytokine Storm
Intervention Drug: Fluoxetine
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment As Usual Fluoxetine
Hide Arm/Group Description Participants may choose to not take fluoxetine and remain in the study

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

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

Period Title: Overall Study
Started 4 12
Completed 4 11
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Arm/Group Title Treatment As Usual Fluoxetine Total
Hide Arm/Group Description Participants may choose to not take fluoxetine and remain in the study

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

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

Total of all reporting groups
Overall Number of Baseline Participants 4 11 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants 11 participants 15 participants
52
(44 to 61)
46.09
(24 to 75)
47.67
(24 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 11 participants 15 participants
Female
3
  75.0%
7
  63.6%
10
  66.7%
Male
1
  25.0%
4
  36.4%
5
  33.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 11 participants 15 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   9.1%
1
   6.7%
White
4
 100.0%
10
  90.9%
14
  93.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 11 participants 15 participants
4 11 15
Smoke Cigarettes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 11 participants 15 participants
Smokes cigarettes
1
  25.0%
1
   9.1%
2
  13.3%
Does not smoke cigarettes
3
  75.0%
10
  90.9%
13
  86.7%
1.Primary Outcome
Title Number of Outpatient Subject Hospitalizations
Hide Description whether the subject is hospitalized for COVID-19 symptoms
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
We had intended this measure for outpatients but had very few study participants who were outpatients.
Arm/Group Title Treatment As Usual Fluoxetine
Hide Arm/Group Description:
Participants may choose to not take fluoxetine and remain in the study

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

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

Overall Number of Participants Analyzed 0 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
0
   0.0%
2.Primary Outcome
Title Number of Subjects Undergoing Intubation
Hide Description whether the subject is intubated for COVID-19 symptoms
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment As Usual Fluoxetine
Hide Arm/Group Description:
Participants may choose to not take fluoxetine and remain in the study

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

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

Overall Number of Participants Analyzed 4 11
Measure Type: Count of Participants
Unit of Measure: Participants
1
  25.0%
0
   0.0%
3.Primary Outcome
Title Number of Patients Who Died Within 2 Months of Entry Into the Study
Hide Description Patients who died from any cause within 2 months of entry into the study.
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
review of charts to determine death by any cause within 2 months of entry into study
Arm/Group Title Treatment As Usual Fluoxetine
Hide Arm/Group Description:
Participants may choose to not take fluoxetine and remain in the study

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

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

Overall Number of Participants Analyzed 4 11
Measure Type: Count of Participants
Unit of Measure: Participants
1
  25.0%
0
   0.0%
4.Secondary Outcome
Title Participants With 1 or More Symptom Free Day With no COVID Primary Symptoms During 2 Months After Study Entry
Hide Description 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
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment As Usual Fluoxetine
Hide Arm/Group Description:
Participants may choose to not take fluoxetine and remain in the study

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

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

Overall Number of Participants Analyzed 4 11
Measure Type: Count of Participants
Unit of Measure: Participants
1 or more symptom free days
3
  75.0%
7
  63.6%
no symptom free days
1
  25.0%
4
  36.4%
5.Secondary Outcome
Title Participants With Patient Health Questionnaire (PHQ) -9 Score Below 10 After Baseline Assessment
Hide Description 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
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment As Usual Fluoxetine
Hide Arm/Group Description:
Participants may choose to not take fluoxetine and remain in the study

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

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

Overall Number of Participants Analyzed 4 10
Measure Type: Count of Participants
Unit of Measure: Participants
4
 100.0%
10
 100.0%
6.Secondary Outcome
Title Participants With Generalized Anxiety Disorder (GAD) -7 Scale Score Below 10 After Baseline Assessment
Hide Description 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
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment As Usual Fluoxetine
Hide Arm/Group Description:
Participants may choose to not take fluoxetine and remain in the study

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

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

Overall Number of Participants Analyzed 4 10
Measure Type: Count of Participants
Unit of Measure: Participants
4
 100.0%
10
 100.0%
Time Frame Adverse event data was collected over up to 2 months from when each participant was enrolled by the study team.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment As Usual Fluoxetine
Hide Arm/Group Description Participants may choose to not take fluoxetine and remain in the study

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

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

All-Cause Mortality
Treatment As Usual Fluoxetine
Affected / at Risk (%) Affected / at Risk (%)
Total   1/4 (25.00%)      0/11 (0.00%)    
Hide Serious Adverse Events
Treatment As Usual Fluoxetine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/4 (25.00%)      0/11 (0.00%)    
Respiratory, thoracic and mediastinal disorders     
Death  [1]  1/4 (25.00%)  1 /11 
Indicates events were collected by systematic assessment
[1]
Patient went in to acute respiratory failure secondary to COVID-19 PNA, coded, was emergently intubated and died after attempts to resuscitate. Patient was in the control arm of the study and did not receive the study drug.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment As Usual Fluoxetine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/11 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Cheryl McCullumsmith, M.D., Ph.D.
Organization: The University of Toledo Department of Psychiatry
Phone: 419-383-5669
EMail: cheryl.mccullumsmith@utoledo.edu
Layout table for additonal information
Responsible Party: Cheryl Mccullumsmith, University of Toledo Health Science Campus
ClinicalTrials.gov Identifier: NCT04377308    
Other Study ID Numbers: FRIDA COVID19
First Submitted: April 18, 2020
First Posted: May 6, 2020
Results First Submitted: March 4, 2022
Results First Posted: September 30, 2022
Last Update Posted: September 30, 2022