1. Evaluation of the therapeutic effect of colchicine plus chloroquine in
comparison with chloroquine in patients with COVID-19 In terms of the outcome including mortality, transference to ICU and discharge
2. Evaluation of the therapeutic effect of colchicine plus chloroquine in
comparison with chloroquine in patients with COVID-19 In terms of the hospitalization duration
3. Evaluation of the therapeutic effect of colchicine plus chloroquine in
comparison with chloroquine in patients with COVID-19 In terms of the cessation of fever
Design
clinical trial, blinded, phase III, with control group, 100 patients divided into 2 groups, randomized using random number table.
Settings and conduct
This blinded clinical trial will be done in Imam Reza hospital of Ardabil on 100 COVID19 patients divided into 2 groups. the participants will be blinded to their regimen.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Pulmonary involvement seen in CT-Scan compatible with COVID19
2. Positive PCR of COVID19
Exclusion criteria:
1. Sensitivity to any medications of regimen
2. Renal failure
3.Heart diseas
4. Pregnancy
5. Reluctance to participate in the study
Intervention groups
Individuals of intervention group will receive 1 mg tablet of colchicine daily. The participants of the placebo group will receive a similar tablet without therapeutic effects.
Main outcome variables
Hospitalization duration; cessation of fever; outcome including mortality; transference to ICU and discharge
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200418047126N1
Registration date:2020-05-14, 1399/02/25
Registration timing:registered_while_recruiting
Last update:2020-05-14, 1399/02/25
Update count:0
Registration date
2020-05-14, 1399/02/25
Registrant information
Name
Farzad Salehzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3371 7486
Email address
salehzadeh_f@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-04, 1399/02/15
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the therapeutic effect of colchicine plus chloroquine in comparison with chloroquine in patients with COVID-19
Public title
Evaluation of colchicine in treatment of coronavirus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Positive PCR for COVID19
Exclusion criteria:
Sensitivity of patients to any medication that is in the regimen
Renal failure
Heart disease
Pregnancy
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals will be divided into intervention or placebo group based on random number table
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study the participants (patients) will be kept blind to the regimen
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ardabil University of Medical Sciences
Street address
Ardabil University of Medical Sciences, Daneshgah street
City
Ardabil
Province
Ardabil
Postal code
5618953141
Approval date
2020-04-18, 1399/01/30
Ethics committee reference number
IR.ARUMS.REC.1399.050
Health conditions studied
1
Description of health condition studied
Pulmonary infection of COVD19
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Hospitalization outcome
Timepoint
Last day of hospitalization in the section
Method of measurement
Calendar
2
Description
Fever cessation
Timepoint
Before hospitalization and 1, 3, 5, 7 days after hospitalization
Method of measurement
calendar
3
Description
Hospitalization time
Timepoint
First and last day of hospitalization
Method of measurement
Calendar
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A 1 mg tablet of colchicine daily for 10 days
Category
Treatment - Drugs
2
Description
Control group: A placebo tablet daily for 10 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza (pbuh) of Ardabil
Full name of responsible person
Farhad Salehzadeh
Street address
Ardabil University of Medical Sciences, Daneshgah street
City
Ardabil
Province
Ardabil
Postal code
5618953141
Phone
+98 45 3351 0054
Email
salehzadeh_f@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Haleh Valizadeh Haghi
Street address
Research Vice Chancellorship section, Ardabil University of Medical Sciences, Daneshgah street
City
Ardabil
Province
Ardabil
Postal code
5618953141
Phone
+98 45 3351 2014
Email
h.valizadeh@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Farhad Pourfarzi
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Social medicine
Street address
Ardabil University of Medical Sciences, Daneshgah street
City
Ardabil
Province
Ardabil
Postal code
5618953141
Phone
+98 45 3353 4798
Email
farhad.pourfarzi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Farhad Salehzadeh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Ardabil University of Medical Sciences, Daneshgah street
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3324 5053
Email
salehzadeh_f@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Shahram Habibzadeh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Ardabil University of Medical Sciences, Daneshgah street
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3353 4798
Email
s.habibzadeh@arums.ac.ir
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available