Trial Outcomes & Findings for Fluoxetine to Reduce Intubation and Death After COVID19 Infection (NCT NCT04377308)
NCT ID: NCT04377308
Last Updated: 2024-06-07
Results Overview
whether the subject is hospitalized for COVID-19 symptoms
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
16 participants
Primary outcome timeframe
2 months
Results posted on
2024-06-07
Participant Flow
Participant milestones
| Measure |
Treatment As Usual
Participants may choose to not take fluoxetine and remain in the study
|
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
Fluoxetine: Fluoxetine 20 mg to 60 mg daily given from 2 weeks to 2 months duration
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
12
|
|
Overall Study
COMPLETED
|
4
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Treatment As Usual
Participants may choose to not take fluoxetine and remain in the study
|
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
Fluoxetine: Fluoxetine 20 mg to 60 mg daily given from 2 weeks to 2 months duration
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Fluoxetine to Reduce Intubation and Death After COVID19 Infection
Baseline characteristics by cohort
| Measure |
Treatment As Usual
n=4 Participants
Participants may choose to not take fluoxetine and remain in the study
|
Fluoxetine
n=11 Participants
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
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Smoke Cigarettes
Smokes cigarettes
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
11 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Age, Continuous
|
52 Years
n=5 Participants
|
46.09 Years
n=7 Participants
|
47.67 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Smoke Cigarettes
Does not smoke cigarettes
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: We had intended this measure for outpatients but had very few study participants who were outpatients.
whether the subject is hospitalized for COVID-19 symptoms
Outcome measures
| Measure |
Treatment As Usual
Participants may choose to not take fluoxetine and remain in the study
|
Fluoxetine
n=9 Participants
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
|
|---|---|---|
|
Number of Outpatient Subject Hospitalizations
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 2 monthswhether the subject is intubated for COVID-19 symptoms
Outcome measures
| Measure |
Treatment As Usual
n=4 Participants
Participants may choose to not take fluoxetine and remain in the study
|
Fluoxetine
n=11 Participants
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
|
|---|---|---|
|
Number of Subjects Undergoing Intubation
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: review of charts to determine death by any cause within 2 months of entry into study
Patients who died from any cause within 2 months of entry into the study.
Outcome measures
| Measure |
Treatment As Usual
n=4 Participants
Participants may choose to not take fluoxetine and remain in the study
|
Fluoxetine
n=11 Participants
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
|
|---|---|---|
|
Number of Patients Who Died Within 2 Months of Entry Into the Study
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 monthsParticipant 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
Outcome measures
| Measure |
Treatment As Usual
n=4 Participants
Participants may choose to not take fluoxetine and remain in the study
|
Fluoxetine
n=11 Participants
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
|
|---|---|---|
|
Participants With 1 or More Symptom Free Day With no COVID Primary Symptoms During 2 Months After Study Entry
1 or more symptom free days
|
3 Participants
|
7 Participants
|
|
Participants With 1 or More Symptom Free Day With no COVID Primary Symptoms During 2 Months After Study Entry
no symptom free days
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 2 monthsdepression 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
Outcome measures
| Measure |
Treatment As Usual
n=4 Participants
Participants may choose to not take fluoxetine and remain in the study
|
Fluoxetine
n=10 Participants
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
|
|---|---|---|
|
Participants With Patient Health Questionnaire (PHQ) -9 Score Below 10 After Baseline Assessment
|
4 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 2 monthsanxiety 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
Outcome measures
| Measure |
Treatment As Usual
n=4 Participants
Participants may choose to not take fluoxetine and remain in the study
|
Fluoxetine
n=10 Participants
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
|
|---|---|---|
|
Participants With Generalized Anxiety Disorder (GAD) -7 Scale Score Below 10 After Baseline Assessment
|
4 Participants
|
10 Participants
|
Adverse Events
Treatment As Usual
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Fluoxetine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment As Usual
n=4 participants at risk
Participants may choose to not take fluoxetine and remain in the study
|
Fluoxetine
n=11 participants at risk
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
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Death
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected over up to 2 months from when each participant was enrolled by the study team.
|
0.00%
0/11 • Adverse event data was collected over up to 2 months from when each participant was enrolled by the study team.
|
Other adverse events
Adverse event data not reported
Additional Information
Cheryl McCullumsmith, M.D., Ph.D.
The University of Toledo Department of Psychiatry
Phone: 419-383-5669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place