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The role of colchicine in the treatment of covid-19 patients hospitalized in the intensive care unit

Protocol summary

Study aim
The role of colchicine in the treatment of patients with Covid-19 Hospitalized in the intensive care unit
Design
Randomized clinical trial with parallel groups on 80 patients. Randomization will be performed using even and odd numbers.
Settings and conduct
The present study will be performed on 80 patients with Covid 19 admitted to the pulmonary intensive care unit of Imam Reza Hospital in Tabriz. Blinding will not be done. Patients will be examined in two groups of intervention (colchicine with routine treatment) and control (routine treatment).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Covid-19 diagnosis based on PCR or clinical signs with lung CT scan, consent to participate in the study, hospitalization in the ICU. Exclusion criteria: Pregnancy or lactation, liver failure, patient dissatisfaction, colchicine sensitivity, renal glomerular clearance less than 20.
Intervention groups
Intervention group: Patients will receive methylprednisolone, Ramedsivir, cefepime, vitamin C, vitamin D, vitamin E, diphenhydramine and pantoprazole, the dose of which according to the ICU physician with colchicine tablets that 1 mg loading dose and 0.5 mg in every morning and night for ten days. Control group: Patients will receive methylprednisolone, ramsadivir, cefepime, vitamin C, vitamin D, vitamin E, diphenhydramine and pantoprazole, the dose of which, according to the ICU physician, for ten days.
Main outcome variables
Disease severity by APACHE II Score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210913052467N1
Registration date: 2022-04-29, 1401/02/09
Registration timing: prospective

Last update: 2022-04-29, 1401/02/09
Update count: 0
Registration date
2022-04-29, 1401/02/09
Registrant information
Name
Omid Reshadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3625 8506
Email address
dr.omidre@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-08-22, 1401/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The role of colchicine in the treatment of covid-19 patients hospitalized in the intensive care unit
Public title
The role of colchicine in the treatment of covid-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Proved Covid-19 diagnosis based on positive PCR test or clinical evidence and CT scan of the lung Hospitalized in the intensive care unit Satisfaction for the study
Exclusion criteria:
Pregnancy or breastfeeding Liver failure Patient dissatisfaction Sensitivity to colchicine Renal glomerular clearance less than 20
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple computer-aided randomization method will be used. A list of numbers from 1 to 80 will be prepared in this method. This list is randomly divided into numbers. Depending on the time of hospitalization, one of these numbers will be assigned to the patient and based on the list created and the order of pairs and individuals, patients will be assigned to the intervention and control groups. The intervention group will be even numbers, and the control group will be odd numbers.
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
Ethics committee of Vice chancellor for research, Tabriz University of Medicalُ Sciences
Street address
Vice chancellor for research, Tabriz University of Medical Sceinces, Daneshgah Square
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2021-06-21, 1400/03/31
Ethics committee reference number
IR.TBZMED.REC.1400.262

Health conditions studied

1

Description of health condition studied
Covid-19
ICD-10 code
J12.81
ICD-10 code description
Pneumonia due to SARS-associated coronavirus

Primary outcomes

1

Description
Disease severity
Timepoint
At the beginning of the study and 10 days after the intervention
Method of measurement
APACHE Score II

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients will recieve methylprednisolone, ramsadivir, cefipime, vitamin C, vitamin D, vitamin E, diphenhydramine and pantoprazole; the dose of which according to the ICU specialist with 1 mg loading and 0.5 mg of colchicine and 0.5 mg every morning and night for 10 days.
Category
Treatment - Drugs

2

Description
Control group: Patients will recieve methylprednisolone, ramsadivir, cefipime, vitamin C, vitamin D, vitamin E, diphenhydramine and pantoprazole; the dose of which according to the ICU specialist for 10 days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr. Kamran Shadvar
Street address
Golghasht Street, Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
imamrezahospital@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samiee
Street address
Third Floor, Number 2 central building, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3335 7310
Email
samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Omid Reshadi
Position
Medical inetrn
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No.1, Mollsadra blvd, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5155891864
Phone
+98 44 3625 8506
Fax
+98 44 3625 8506
Email
Dr.omidre@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Omid Reshadi
Position
Medical inetrn
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No.1, Mollsadra blvd, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5155891864
Phone
+98 44 3625 8506
Fax
+98 44 3625 8506
Email
Dr.omidre@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Omid Reshadi
Position
Medical inetrn
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No.1, Mollsadra blvd, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5155891864
Phone
+98 44 3625 8506
Fax
+98 44 3625 8506
Email
Dr.omidre@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
No - There is not 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
Study data is categorized and coded with no identifiable names.
When the data will become available and for how long
Access to study data after publication of the result is available in the journal.
To whom data/document is available
Anyone interested in using the data can access the study data.
Under which criteria data/document could be used
Study data can be used for comparison with other results.
From where data/document is obtainable
Refer to the study's scientific or public accountability person for data.
What processes are involved for a request to access data/document
The request will be sent by email to person responsible for scientific or public inquiries.
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