Protocol summary

Study aim
Determining the effect of fluoxetine on ESR and CRP levels in covid disease patients
Design
A clinical trial with a control group, with parallel groups, one-way blind, randomized, phase 3 on 60 patients, will be divided into two groups to randomize patients using a random number table based on a sequence of computer random numbers.
Settings and conduct
This study was performed in Kowsar Hospital from 1400 to 1401. We divide the patient with using a random number table into two groups, give the first group one 20 mg fluoxetine tablet each night, and the second group a placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Definitive diagnosis of Covid 19 ; Having written consent from the patients participating in the study Exclusion criteria: Reluctance of patients to cooperate in the study; Liver and kidney failure ; Taking drugs that interfere with fluoxetine
Intervention groups
We divide the patient with Quid using a random number table into two groups, give the first group one 20 mg fluoxetine tablet each night, and the second group a placebo.
Main outcome variables
CRP ESR

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220404054411N1
Registration date: 2023-01-14, 1401/10/24
Registration timing: registered_while_recruiting

Last update: 2023-01-14, 1401/10/24
Update count: 0
Registration date
2023-01-14, 1401/10/24
Registrant information
Name
kimia sobouti moghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3351 2458
Email address
kimia.moghadam9676@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The association between fluoxetine and level of ESR , CRP in patients with covid-19
Public title
The effect of fluoxetine on covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnose of covid 19 Have a written consent
Exclusion criteria:
Liver and kidney failure Taking drug that interfere with fluoxetine
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with covid-19 referring to Kausar Hospital are included in the study and then they are divided into two groups A and B using the restricted randomization division method with blocks of six. We give fluoxetine (A) to one group and placebo (B) to the other group. In fact, each block of six includes three A and three B. We give fluoxetine (A) to one group and placebo (B) to the other group. In fact, each block of six includes three A and three B. The number of possible states of blocks of six is 20. Among these 20 blocks of six, according to the sample size, a block of six is randomly selected and based on that, the patients are assigned to two groups. The randomization method is such that to each of the twenty six possible random blocks we assign a sampling number. (FFFCCC,FCFFCC,FFCCFC,……….,CCCFFFF) (F represents the fluoxetine group and C represents the placebo group.) For example: FFFCCC=00-04 FCFFCC=05-09 FFCCFC=10-14 ……. CCCFFF=95-99 There are twenty categories and each category contains 5 numbers, which are 5 sampling numbers for each block. Using the table of random numbers, we choose a two-digit number (from 00 to 99) at random. Suppose the selected number is 08 (or any number between 05 and 09), so the block of six FCFFCC is selected . Considering the sample size of 60, we select ten two-digit random numbers from the table of random numbers, to which ten blocks of six are assigned. We put these ten blocks one after the other . Gradually, when the patient enters the study, one of the letters F or C is assigned to it, which shows which group the patient is in.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study , after selecting the sample and describing the objectives of the study , participants (patients) will be randomly divided into two groups . A separate code is defined for each person and the participants will be given the main drug and placebo without knowing which group they are in . blinding will inform
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Science
Street address
No.15 , 502 ave , Faz 4 Mehrshahr , , Alborz
City
Semnan
Province
Semnan
Postal code
3183756717
Approval date
2022-03-27, 1401/01/07
Ethics committee reference number
IR.SEMUMS.REC.1401.001

Health conditions studied

1

Description of health condition studied
COVID-19 disease
ICD-10 code
U07.1
ICD-10 code description
U07.1 COVID-19, virus identified

Primary outcomes

1

Description
Determining the effect of fluoxetine on the red blood cell sedimentation rate in patients with COVID-19 infection
Timepoint
Before the intervention and 2 weeks after the intervention
Method of measurement
Blood level measurement by laboratory

2

Description
Determining the effect of fluoxetine on the C-reactive protein in patients with COVID-19 infection
Timepoint
Before the intervention and 2 weeks after the intervention
Method of measurement
Blood level measurement by laboratory

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Fluoxetine 20 mg , Selective serotonin reuptake inhibitor , The patient takes 20 mg of fluoxetine daily from the time of admission , We continue the medicine until the patient recovers and then gradually reduce the dose of the medicine and then stop.
Category
Treatment - Drugs

2

Description
Control group: The drug is similar to the intended drug, which will be prepared and purchased from Pars Daru factory, which is the original drug. And then the affected patient takes a placebo a day from the time of hospitalization. We continue the drug until the patient recovers and then gradually reduce and then stop the dose of the placebo as in the intervention group.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar hospital
Full name of responsible person
Kimia Sobouti Moghadam
Street address
Amin Street , Golestan Town , Semnan
City
Semnan
Province
Semnan
Postal code
35198
Phone
+98 23 3142 2291
Fax
Email
Kosarhos@semums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
kimia Sobouti Moghadam
Street address
Amin Street , Golestan Town , Semnan
City
Semnan
Province
Semnan
Postal code
3514743984
Phone
+98 912 848 5998
Email
kimia.moghadam9675@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Semnan university of Medical Science
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
Semnan University of Medical Sciences
Full name of responsible person
Kimia Sobouti Moghadam
Position
Medical intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No.84 , Varzesh Ave , Semnan Town
City
Semnan
Province
Semnan
Postal code
3514743984
Phone
+98 23 3344 3147
Email
Kimia.moghadam9675@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Kimia Sobouti Moghadam
Position
Medical intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No.84 , Varzesh Ave , Semnan Town
City
Semnan
Province
Semnan
Postal code
3514743984
Phone
+98 23 3344 3147
Email
Kimia.moghadam9675@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Kimia Sobouti Moghadam
Position
Medical intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No.84 , Varzesh Ave , Semnan Town
City
Semnan
Province
Semnan
Postal code
3514743984
Phone
+98 23 3344 3147
Email
Kimia.moghadam9675@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Access period starts 6 months after results are published
To whom data/document is available
The data of this research will be available to all researchers working in academic and scientific institutions
Under which criteria data/document could be used
They can request this email for information. mff45@yahoo.com
From where data/document is obtainable
They can request this email for information. mff45@yahoo.com
What processes are involved for a request to access data/document
They can request this email for information. mff45@yahoo.com
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