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Effect of fluvoxamine medicine on cytokine level of COVID-19 patients, hospitalized in ICU ward

Protocol summary

Study aim
Evaluating the IL-6 level in COVID-19 patients hospitalized in Intensive Care Unit (ICU), after consuming Fluvoxamine. Comparing the IL-6 level in two groups of COVID-19 patients, hospitalized in ICU, with the history of consuming Fluvoxamine and without it.
Design
Clinical trial with two control and intervention groups, which are dedicated randomly. 20 patients participate in each group and the intervention group is being treated by Fluvoxamine.
Settings and conduct
The place of work is Massih Daneshvari Hospital, which 40 hospitalized patients in ICU ward due to COVID-19 are selected by accessible method of sampling. The demographic researcher made questionnaire is completed by all of the sample group at first. Then the level of Erythrocyte Sedimentation Rate (ESR), Interlukin-6 (IL-6) and C-Reactive Protein (CRP) are measured in them. Then they are dedicated to experimental and control groups. The experimental group receives fluvoxamine drug, but the control group does not. The level of ESR, IL-6 and CRP are measured again in all 40 patients when discharging from the ICU.
Participants/Inclusion and exclusion criteria
Patients who had been hospitalized in ICU due to COVID-19 participate in the study. Patients who have been hospitalized in any hospital wards due to any diseases, except COVID-19, would not enter to the research project.
Intervention groups
The intervention group receive fluvoxamine and the control group does not receive it. The fluvoxamine dosage starts from 50 mg daily. It raises up to 300 mg per week, depending on the patient tolerance to drug. All of the patients are daily visited by the psychiatrist for psychological symptoms and also possible fluvoxamine side effects. They also visit by psychiatrist, for tapering or stopping the fluvoxamine consumption, after discharging from ICU.
Main outcome variables
Measuring the level of CRP, IL-6 and ESR by blood pressure.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131115015405N4
Registration date: 2020-10-03, 1399/07/12
Registration timing: retrospective

Last update: 2020-10-03, 1399/07/12
Update count: 0
Registration date
2020-10-03, 1399/07/12
Registrant information
Name
Mitra Safa
Name of organization / entity
Massih Daneshvari Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2712 2607
Email address
m.safa@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-09-05, 1399/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of fluvoxamine medicine on cytokine level of COVID-19 patients, hospitalized in ICU ward
Public title
Effect of fluvoxamine on cytokine in COVID-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent Being conscious Definite diagnosis of COVID-19 in medical records of the patient Age over 18 years old Normal serum level of Creatinine, Blood Ureh Nitrogen, White Blood Cell, Potassium, Sodium and Fasting Blood Sugar
Exclusion criteria:
Being pregnant. Existence of ASA, Warfarin, MAOI, Lithium, Clomipramine, NSAIDs, Methadone, Capropril, Diltiazem and Zolpidem drugs in medical files of the patient. Simultaneous consumption of any kind of alcohol or substance.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization method is applied, which the written names of the participants are placed in a container, separately. Then one of the members of research team choose 20 of them randomly, as the intervention group, without the possibility of seeing the names. The rest of 20 names are allocated to control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National Research Institute of Tuberculosis and Lung Diseases
Street address
Massih Daneshvari Hospital, Daar-Abad, Niavaran, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2020-09-16, 1399/06/26
Ethics committee reference number
IR.SBMU.NRITLD.REC.1399.177

Health conditions studied

1

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

Primary outcomes

1

Description
Interlukine - 6 (IL-6) level will be measured in COVID-19 patients.
Timepoint
The Interlukine - 6 level will be measured both before the consumption of Fluvoxamine drug and when discharging from the ICU ward.
Method of measurement
Measuring kit of Interlukine - 6 by blood test.

2

Description
Erythrocyte Sedimentation Rate (ESR) level will be measured in COVID-19 patients.
Timepoint
The Erythrocyte Sedimentation Rate (ESR) level will be measured both before the consumption of Fluvoxamine drug and when discharging from the ICU ward.
Method of measurement
Measuring kit of Erythrocyte Sedimentation Rate (ESR) by blood test.

3

Description
C-Reactive Protein (CRP) level will be measured in COVID-19 patients.
Timepoint
The C-Reactive Protein (CRP) level will be measured both before the consumption of Fluvoxamine drug and when discharging from the ICU ward.
Method of measurement
Measuring kit of C-Reactive Protein (CRP) by blood test.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: This group will be treated by Fluvoxamine drug. The drug dosage will be increased up to 300 mg daily depending on the patients tolerance to the drug. At first, 50 mg will be prescribed per night. after 2 days, 100 mg will be prescribed per night. After 4 days, 100 mg will be prescribed per afternoon and 100 mg will be prescribed per night. After 4 days, 100 mg will be prescribed per morning, 100 mg will be prescribed per afternoon and 100 mg will be prescribed per night. Pharmaceutical companies including Abidi and Sobhan produce Fluvoxamine drug in Iran. Thus, the Fluvoxamine produced by each of the mentioned pharmaceutical companies will be used in the current project.
Category
Treatment - Drugs

2

Description
Control group: This group will not receive Fluvoxamine drug. But all of the members undergo COVID-19 treatment in Intensive Care Unit under the supervision of the specialist physician, like the intervention group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Massih Daneshvari Hospital
Full name of responsible person
Mitra Safa
Street address
Massih Daneshvari Hospital, Daar-Abad, Niavaran, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3000
Email
pr.nritld@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mitra Safa
Street address
Massih Daneshvari Hospital, Daar-Abad, Niavaran, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2607
Email
mitra.safa@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mitra Safa
Position
Professor, head of psychiatry department in Massih Daneshvari hospital
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Massih Daneshvari Hospital, Daar-Abad, Niavaran, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2607
Email
mitra.safa@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mitra Safa
Position
Professor, Head of psychiatry department in Massih Daneshvari hospital
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Massih Daneshvari hospital, Daar-Abad, Niavaran, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2607
Email
mitra.safa@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mitra Safa
Position
Professor, head of psychiatry department in Massih Daneshvari hospital
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Massih Daneshvari Hospital, Daar-Abad, Niavaran, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2607
Email
mitra.safa@yahoo.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All participants data will be presented as article, when finalizing the work, because their data does not contain identification information.
When the data will become available and for how long
Accessing to data would be possible after publication of the article.
To whom data/document is available
All academic researchers can access to data.
Under which criteria data/document could be used
When the article is published, all academic researchers can send a request for accessing the data, then the results will be announced after some considerations.
From where data/document is obtainable
The corresponding author and his/her email address will be determined in published article, which every one who needs the data can use it.
What processes are involved for a request to access data/document
When the applicant send a request through email address, the results will be announced in a week.
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