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Evaluation of the effect of colchicine in the treatment of patients with COVID-19

Protocol summary

Study aim
Evaluation of the effect of colchicine in the treatment of patients with COVID-19
Design
This study is a double-blind clinical trial with parallel groups. In this study, 82 patients with COVID-19 who met the inclusion criteria were divided into two identical groups, colchicine and placebo, using a simple individual randomization method. This is a phase 3 trial.
Settings and conduct
In this double-blind clinical trial study, 82 patients with COVID-19 who met the inclusion criteria were included in the study. These patients are divided into two equal groups of colchicine and placebo by individual randomization method. In the colchicine group, in addition to the standard treatment, patients receive one 500 microgram of colchicine tablets daily for 10 days. In the placebo group, patients receive a placebo tablet containing starch in addition to standard treatment. Finally, the two groups are compared in terms of main outcomes.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Patients with COVID-19 infection 16 years and older , Patients admitted to the infectious ward of COVID-19 hospitals in Arak Non-entry criteria : Pregnancy and lactation , Existence of liver and kidney disorders , Age less than 16 years
Intervention groups
In the colchicine group, in addition to the standard treatment, patients receive one 500 microgram of colchicine tablets daily for 10 days. In the placebo group, patients receive a placebo tablet containing starch in addition to standard treatment.
Main outcome variables
Duration of hospitalization, complete blood cell count, liver function test, serum urea and creatinine, creatine phosphokinase, serum sodium and potassium levels, blood sugar, serum magnesium level, serum lactate dehydrogenase level, ferritin, oxygen saturation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191104045328N7
Registration date: 2021-07-17, 1400/04/26
Registration timing: prospective

Last update: 2021-07-17, 1400/04/26
Update count: 0
Registration date
2021-07-17, 1400/04/26
Registrant information
Name
Amin Haji seyyed hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3366 7583
Email address
amin.medstu@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-06, 1400/05/15
Expected recruitment end date
2022-01-05, 1400/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of colchicine in the treatment of patients with COVID-19
Public title
Evaluation of the effect of colchicine in the treatment of patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with COVID-19 infection 16 years and older Patients admitted to the infectious ward of COVID-19 hospitals in Arak
Exclusion criteria:
Pregnancy and lactation Existence of liver and kidney disorders Age less than 16 years
Age
From 16 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 41
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simply an individual with an envelope. In this method, we will select a number of cards or letters as the intervention group and the same number of cards for the control group, then we will merge the cards together and take out one card and The allocation was recorded and the card will be returned to all other cards after it is removed, then the cards will be merged again and another card will be issued. This process will continue until a random sequence is reached according to the sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, in one group, in addition to the standard treatment, colchicine tablets are given. In the other group, a processed placebo tablet containing starch is used instead of calcicin. Therefore, the participant and the caregiver (nurse) are unaware of the contents of the pill and the study group. The pills are delivered to the nurse by the prepared researcher.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2021-05-30, 1400/03/09
Ethics committee reference number
IR.ARAKMU.REC.1400.042

Health conditions studied

1

Description of health condition studied
Coronavirus disease 2019
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified

Primary outcomes

1

Description
Duration of hospitalization
Timepoint
After patient discharge
Method of measurement
Days of hospitalization

2

Description
oxygen saturation
Timepoint
The first, third, fifth and seventh day of hospitalization
Method of measurement
Oximeter pulse

3

Description
Laboratory findings (complete blood cell count, liver function test, serum urea and creatinine, creatine phosphokinase, serum sodium and potassium levels, blood sugar, serum magnesium level, serum lactate dehydrogenase level, ferritin)
Timepoint
The first and seventh day of hospitalization
Method of measurement
Taking a blood sample

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: in addition to the standard treatment, patients receive one 500 microgram of colchicine tablets daily for 10 days.
Category
Treatment - Drugs

2

Description
Control group: patients receive a placebo tablet containing starch in addition to standard treatment.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali Asr hospital
Full name of responsible person
Dr Hosein Sarmadian
Street address
Valiasr Hospital,Shahid Shiroudi Street, Arak, Iran
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
hosseinsarmadian2015@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Hosein Sarmadian
Position
Arak
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Valiasr Hospital,Shahid Shiroudi Street, Arak, Iran
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
hosseinsarmadian2015@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Ehsanollah Ghznavi Rad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
Valiasr Hospital,Shahid Shiroudi Street, Arak, Iran
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
e.ghaznavirad@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nazanin Pourafshari
Position
Infectious disease Resident
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Valiasr Hospital,Shahid Shiroudi Street, Arak, Iran
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
nazanin.pourafshari21@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
After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study.
When the data will become available and for how long
Access will be from 2022/4/20 to 2026/4/20 for 4 years.
To whom data/document is available
University researchers
Under which criteria data/document could be used
University researchers
From where data/document is obtainable
Dr Hosein Sarmadian
What processes are involved for a request to access data/document
Letter writing should be done with professors and universities.
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