Protocol summary

Study aim
This study will be performed to determine the efficacy of colchicine versus placebo in the treatment of outpatients with COVID-19.
Design
A two-arm, parallel, randomized, single-blind, controlled clinical trial on 500 COVID-19 outpatients. Random blocks will be used for randomization.
Settings and conduct
This study will be performed on outpatients with COVID-19 in an outpatient clinic under infectious disease specialists' supervision. After confirming the disease with the RT-PCR test and meeting the inclusion criteria, they will be randomly assigned to one of the two groups. Also, the participants will be blinded.
Participants/Inclusion and exclusion criteria
Patients with the new coronavirus infection 2019 (COVID-19) confirmed by the RT-PCR test with the approval of an infectious disease specialist and an indication for outpatient treatment status (do not have any of the following): PaO2/FiO2 < 300, SpO2 < 93%, Respiratory rate > 30, Progressive lung involvements in CT scan The patient must meet at least one of the following high-risk criteria: 70 years of age or older, obesity (BMI ≥ 30 kg/m2), diabetes, uncontrolled blood pressure (systolic blood pressure > 150 mm Hg), known case of respiratory disease (Including asthma or COPD), known case of heart failure, known case of coronary artery disease, fever > 38.4°C in the last 48 hours, shortness of breath at the time of enrollment, Bicytopenia, Pancytopenia or a combination of neutrophilia and lymphopenia.
Intervention groups
The control group will receive placebo tablet BID for the first three days, then QD for the next 27 days. The intervention group will receive colchicine 0.5 mg tablet BID for the first three days, then QD for the next 27 days.
Main outcome variables
1) Require hospitalization 2) Death

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201024049134N3
Registration date: 2021-06-21, 1400/03/31
Registration timing: prospective

Last update: 2021-06-21, 1400/03/31
Update count: 0
Registration date
2021-06-21, 1400/03/31
Registrant information
Name
Mohammad Barary
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 0124
Email address
m.barary@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of colchicine in patients with COVID-19 infection: A randomized, single-blind, placebo-controlled clinical trial
Public title
Efficacy of colchicine in the treatment of COVID-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women of at least 18 years of age capable of providing informed consent. Confirmation of COVID-19 with RT-PCR in the last 24 hours Patients with outpatient treatment status (do not have any of the following): PaO2/FiO2 < 300, SpO2 < 93%, Respiratory rate > 30, Progressive lung involvements in CT scan The patient must meet at least one of the following high-risk criteria: 70 years of age or older, obesity (BMI ≥ 30 kg/m2), diabetes, uncontrolled blood pressure (systolic blood pressure > 150 mm Hg), known case of respiratory disease (Including asthma or COPD), known case of heart failure, known case of coronary artery disease, fever > 38.4°C in the last 48 hours, shortness of breath at the time of enrollment, Bicytopenia, Pancytopenia or a combination of neutrophilia and lymphopenia
Exclusion criteria:
The patient is currently hospitalized or needs immediate care and hospitalization. Showing any symptoms of shock or hemodynamic instability. History of inflammatory bowel disease (Crohn's disease or ulcerative colitis), chronic diarrhea or malabsorption. History of progressive neuromuscular disease. Estimated glomerular filtration rate (eGFR) < 30 ml/min in 1.73 m2 using MDRD equation. History of cirrhosis, chronic active hepatitis or severe liver disease. Pregnant, breastfeeding, or women Intending to get pregnant during the study period or 6 months after the last dose of study agent. History of colchicine use for other conditions, including Familial Mediterranean Fever or gout. History of allergic reaction or severe sensitivity to colchicine. Cancer patients undergoing active chemotherapy.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
Sample size
Target sample size: 500
Randomization (investigator's opinion)
Randomized
Randomization description
Unit randomization is done by block method with a block size of 4. For each of the 6 possible scenarios for the quadruple block, the numbers are assigned as follows AABB (1), ABAB (2), ABBA (3), BBAA (4), BABA (5), BAAB (6). With the help of a dice, the numbers between 1 and 6 are selected, and the treatment allocation list is determined according to each number. To execute the generated random sequence, the method of hiding coded boxes or cans is used. In this method, the cans are numbered in a random sequence. Inside the boxes, the desired intervention (drug) or a sheet on which the random allocation is written is provided to the executor with the condition that the boxes are completely sealed. Finally, the researcher assigns patients to the standard intervention and treatment group based on patients' admission orders. Tools: Create random sequences of 4 random blocks Concealment to execute random sequences on study participants will be done. How to make blocks: Randomly select the block and read the letters from right to left. Hiding will be done by the method of cans that are numbered in random sequence. The cans are the same weight and shape and will be prepared by an independent researcher.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, patients will be blinded. However, due to the similar appearance and injection method of the drug and placebo, the patient can not know which one he/she received.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Babol University of Medical Sciences
Street address
GanjAfrooz Blvd.
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2021-05-31, 1400/03/10
Ethics committee reference number
IR.MUBABOL.REC.1400.125

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
Require hospitalization
Timepoint
30 days after the start of the intervention
Method of measurement
Examination of the patients by the research team

2

Description
Severely ill
Timepoint
30 days after the start of the intervention
Method of measurement
Examination of the patients by the research team

3

Description
Death
Timepoint
30 days after the start of the intervention
Method of measurement
Examination of the patients by the research team

Secondary outcomes

1

Description
Requiring mechanical ventilation
Timepoint
30 days after the start of the intervention
Method of measurement
Examination of the patients by the research team

2

Description
Incidence of severe complications, such as pulmonary fibrosis, prolonged illness, or malaise
Timepoint
30 days after the start of the intervention
Method of measurement
Examination of the patients by the research team

Intervention groups

1

Description
Control group: Patients in this group receive placebo tablets (containing oral calcium chloride, Caspian Pharmaceutical Company, Iran) for the first 3 days, twice a day, and then for the next 27 days, once a day. In addition to placebo, these participants will be prescribed the drugs listed in the National Covid-19 Treatment Protocol (including famotidine, cetirizine, N-acetylcysteine, bromhexine, naproxen, and fluticasone spray ).
Category
Placebo

2

Description
Intervention group: Colchicine 0.5 mg tablets for the first 3 days, twice a day, and then for the next 27 days, once a day. In this group, in addition to colchicine, people will be prescribed drugs listed in the national protocol for the treatment of Covid-19 disease (including famotidine, cetirizine, N-acetylcysteine, bromhexine, naproxen, and fluticasone spray ).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rouhani hospital outpatient clinic
Full name of responsible person
Masumeh Bayani
Street address
GanjAfrooz Blvd.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3223 8301
Email
m_baiany@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
GanjAfrooz Blvd.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 7667
Fax
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Web page address
http://research.mubabol.ac.ir/about/?id=350
Grant name
Grant code / Reference number
140012019
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Mohammad Barary
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 88, Khosravan ave., Moallem 12 st., Shariaty blvd.
City
Babol
Province
Mazandaran
Postal code
4714743568
Phone
+98 11 3236 0124
Fax
Email
m.barary@mubabol.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Masumeh Bayani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Vice-Chancellor for public health affairs, Shahid Modarres blvd.
City
Babol
Province
Mazandaran
Postal code
4714934937
Phone
+98 11 3233 6875
Fax
+98 11 3236 3875
Email
m_baiany@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mohammad Barary
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No.88, Khosravan 10 ave., Moallem 12 st., Shariaty blvd.
City
Babol
Province
Mazandaran
Postal code
4714743568
Phone
+98 11 3236 0124
Email
m1377b@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 participants' personal data can be shared after the anonymization of individuals.
When the data will become available and for how long
Six months after the end of the study and publication of the article
To whom data/document is available
The data of this study will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
There are no specific preconditions.
From where data/document is obtainable
They should send their request to the person in charge of the study, Dr. Masumeh Bayani, with the e-mail address: m_baiany@yahoo.com.
What processes are involved for a request to access data/document
On average, it will take two weeks to process the application.
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