Efficacy and safety of adding fluoxetine to the therapeutic regimen of hospitalized patients with non critical pneumonia of COVID-19: A double blinded randomized placebo controlled clinical trial
Efficacy and safety of adding Fluoxetine and placebo to the therapeutic regimen of patients with corona virus disease (COVID19) pneumonia.
Design
Phase 3, double blinded clinical trial with parallel groups on 72 patients. Randomization method is block randomization, using the Random allocation software
Settings and conduct
After evaluation and getting informed consent, patients will be randomly divided into intervention and placebo groups. Throughout the study, they will be assessed for clinical, laboratory and psychiatric signs and symptoms. Aside from nationally approved regimen, they will either receive Fluoxetine ( 10mg for 4 days followed by 20mg for 24 days) or the similar looking placebo, placed in coded bottles by the pharmacist of the group and so, all other participants are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1.16-65 years old patients with established corona virus disease, hospitalized in non critical wards
2.Patient's consent to participate in the study
Exclusion criteria
1.Severe medical or psychiatric disorders or obesity
2.History of psychotropic medication use in the past 2 months or substance use
3.Pregnancy
Intervention groups
The intervention will start with adding 10 mg Fluoxetine per day to the fixed anti corona regimen for the first 4 days, followed by 20 mg Fluoxetine for the rest of the 4 weeks. The placebo group will receive similar looking placebo for the same amount of time.
Main outcome variables
Blood oxygen saturation; Number of days of hospitalization; The Need for intubation; ICU admission; Death
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200904048616N1
Registration date:2021-05-06, 1400/02/16
Registration timing:prospective
Last update:2021-05-06, 1400/02/16
Update count:0
Registration date
2021-05-06, 1400/02/16
Registrant information
Name
Faranak Sedighi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3328 5659
Email address
f.sedighi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-21, 1400/02/31
Expected recruitment end date
2021-07-22, 1400/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety of adding fluoxetine to the therapeutic regimen of hospitalized patients with non critical pneumonia of COVID-19: A double blinded randomized placebo controlled clinical trial
Public title
efficacy and safety of adding fluoxetine to therapeutic regimen of patients with COVID-19 pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient's informed consent to participation in the study
Speaking persian
Established diagnosis of Covid-19 by a positive PCR or typical signs of the infection in lung ct scan
Absence of depression, anxiety or other psychiatric disorders
Absence of mental retardation
Negative history of using psychotropic medication in the past 8 weeks
No history of hepatic, renal or cardiac disorders
BMI<30
Negative history of cigarette or other substance use
Admission in non-ICU wards at the beginning of the intervention
Absence of melatonin in the therapeutic regimen of the patient
Fixed therapeutic regimen
Not being pregnant at the time of admission
Exclusion criteria:
Suffering from the critical form of covid-19
Occurance of drug allergy or severe adverse effects of fluoxetine
Necessity of changing the therapeutic regimen
Inability in taking oral medications
A score of 8 and above in any of HADS components
Age
From 16 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method was block randomization. 12 blocks of 6 will be provided by the Random Allocation software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, both the active drug and the similar looking placebo are placed in similar bottles. on each bottle the related blocking code is written. The blocking allocation data and the nature of the capsules assigned to each code is only known to the clinical pharmacist consultant of the trial. Therefore the patients, the colleagues who interview and examine the patients and study the outcomes, the statistical analyst and the main researcher who supervises the whole process are all blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of mazandaran university of medical siences
Street address
Sari Imam Khomeini hospital, Razi st
City
Sari
Province
Mazandaran
Postal code
4816633131
Approval date
2020-12-02, 1399/09/12
Ethics committee reference number
IR.MAZUMS.REC.1399.760
Health conditions studied
1
Description of health condition studied
Coronavirus disease (COVID-19)
ICD-10 code
U07.1
ICD-10 code description
a confirmed diagnosis of the 2019 novel coronavirus disease (COVID-19) as documented by the provider, documentation of a positive COVID-19 test result, or a presumptive positive COVID-19 test result.
Primary outcomes
1
Description
Number of days of hospitalization
Timepoint
Daily from admission
Method of measurement
Number of days of hospital stay until patient's discharge
2
Description
Rate of need for intubation
Timepoint
Daily from admission
Method of measurement
Ratio of intubated patients to all of the patients in both intervention and placebo groups
3
Description
Mortality rate
Timepoint
Daily during hospitalization
Method of measurement
Ratio of deceased patients to the total number of patients admitted to the study
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group will be prescribed with Fluoxetine capsules for 28 days, with 10 milligram for the first 4 days followed by 20 milligram for the rest of the 4 week period. The drug will be given as a single dose at lunch time. The medicine will be provided from Abidi Pharmaceutical Company.
Category
Treatment - Drugs
2
Description
Control group: In this group, placebo containing capsules that are completely identical to the medicine prescribed in the intervention group, will be given as a single dose at lunch time for 28 days. The placebo will be provided by Abidi Pharmaceutical Company.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sari Imam Khomeini hospital
Full name of responsible person
Forouzan Elyasi
Street address
Imam Khomeini Hospital, Razi St.
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
forouzan.elyasi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeidi
Street address
Deputy of research and technology, Moallem square
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3325 7230
Email
msaidi@mazums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
faranak sedighi tonekaboni
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Psychosomatic ward, Sari Imam Khomeini hospital, razi st.
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
faranak.sedighi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Forouzan Elyasi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Psychosomatic ward, Sari Imam Khomeini hospital, Razi st.
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3337 0885
Email
forouzan.elyasi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Faranak Sedighi Tonekaboni
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Psychosomatic ward, Sari Imam Khomeini hospital, Razi St.
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3337 0885
Email
faranak.sedighi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Study protocol data can be shared
When the data will become available and for how long
Access period starts after the publication of the results
To whom data/document is available
All academic researchers
Under which criteria data/document could be used
No other conditions are required
From where data/document is obtainable
Please contact with Dr. Forouzan Elyasi via email at forouzan.elyasi@gmail.com.
What processes are involved for a request to access data/document
Information will be sent within a few days of the email