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The effectiveness of colchicine in the incidence of pulmonary complications after COVID-19 infection: a randomized clinical trial

Protocol summary

Study aim
Determining the effectiveness of colchicine in improving pulmonary fibrosis and preventing bronchiectasis/cavitary lesions/air retention lesions and bronchitis after COVID-19 compared to the control group
Design
Clinical trial work with a control group without blinding, randomized, phase 3 on 100 patients The method of randomization will be that by using the table of random numbers created on the online site, patients will be assigned to 2 groups, and the method of allocation will be by using envelopes in bed.
Settings and conduct
The way of entering the patients into the study is random and the patients referred to Vasi Hospital who have been diagnosed with Covid-19 will be divided into 2 groups. A group of patients who were prescribed colchicine by a doctor are compared with the control group, which are patients who were not prescribed colchicine by other doctors.
Participants/Inclusion and exclusion criteria
Eligibility criteria: Patients who have been clinically, radiologically and PCR confirmed to have COVID-19 Age above 18 years Informed written consent Exit criteria during the study: Cases of colchicine contraindications and cases that do not meet the above criteria
Intervention groups
In the intervention group, after recovering from the acute phase, they will receive colchicine 0.5 mg twice a day for a period of one month. After the 3-month period, lung CT scan will be performed to investigate post-covid pulmonary complications, and the variables of pulmonary fibrosis, cavitary lesions, bronchitis, bronchiectasis, and air trapping lesions will be evaluated and quantitatively compared in terms of the number of involved lobes in both groups.
Main outcome variables
Pulmonary fibrosis; bronchitis; bronchiectasis; cavitary lesions; Air retention lesions

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251112067972N1
Registration date: 2026-04-23, 1405/02/03
Registration timing: registered_while_recruiting

Last update: 2026-04-23, 1405/02/03
Update count: 0
Registration date
2026-04-23, 1405/02/03
Registrant information
Name
Fateme Alizadeh moosavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4465 1300
Email address
alizademoosavif01@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-01-26, 1404/11/06
Expected recruitment end date
2026-05-20, 1405/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of colchicine in the incidence of pulmonary complications after COVID-19 infection: a randomized clinical trial
Public title
The effect of colchicine in patients with covid 19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have been clinically, radiologically and PCR confirmed to have COVID-19 Age above 18 years Informed written consent
Exclusion criteria:
History of hypersensitivity to colchicine Pregnancy or lactation Patients with severe renal impairment (creatinine clearance [CrCl] < 30 mL/min) Patients with severe hepatic impairment (AST or ALT > 5 times the upper limit of normal [ULN]) Patients with hematologic dyscrasias, absolute neutrophil count < 1,000/mm³ or platelet count < 50,000/mm³ Patients with a history of severe heart failure Severe diarrhea, diverticulitis, or bowel perforation Patients unable to tolerate oral intake Patient demise Concomitant use of medications with contraindications to colchicine
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization will be that by using the table of random numbers created on the online site, the patients will be assigned to 2 groups and the method of allocation will be using envelopes in bed.
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 sabzevar University of Medical Sciences
Street address
Sabzevar, Shohadaye Hasteiee Boulevard, Sabzevar University of Medical Science
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873137
Approval date
2025-03-09, 1403/12/19
Ethics committee reference number
IR.MEDSAB.REC.1403.188

Health conditions studied

1

Description of health condition studied
COVID-19 disease
ICD-10 code
U07.1+J12.
ICD-10 code description
COVID-19, virus identified /Other viral pneumonia

Primary outcomes

1

Description
Investigating changes in pulmonary fibrosis in CT scan of patients with covid-19
Timepoint
CT scan evaluation of patients' lungs 3 months later
Method of measurement
Investigation of lesions in lung CT scan

2

Description
Investigating changes in pulmonary bronchiectasis in CT scan of patients with covid-19
Timepoint
CT scan evaluation of patients' lungs 3 months later
Method of measurement
Investigation of lesions in lung CT scan

3

Description
Investigating changes in bronchitis in CT scan of patients with covid-19
Timepoint
CT scan evaluation of patients' lungs 3 months later
Method of measurement
Investigation of lesions in lung CT scan

4

Description
Investigating changes in cavitary lesions and air retention in CT scan of patients with covid-19
Timepoint
CT scan evaluation of patients' lungs 3 months later
Method of measurement
Investigation of lesions in lung CT scan

5

Description
Investigating changes in air retention in CT scan of patients with covid-19
Timepoint
CT scan evaluation of patients' lungs 3 months later
Method of measurement
Investigation of lesions in lung CT scan

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, after recovering from the acute phase, they will receive colchicine 0.5 mg twice a day for a period of one month. After the 3-month period, lung CT scan will be performed to investigate post-covid pulmonary complications, and the variables of pulmonary fibrosis, cavitary lesions, bronchitis, bronchiectasis and air trapping lesions will be evaluated and quantitatively compared in terms of the number of involved lobes in both groups.
Category
Treatment - Drugs

2

Description
Control group: In the control group, after recovering from the acute phase, they will receive placebo twice a day for a period of one month. After the 3-month period, lung CT scan will be performed to investigate post-covid pulmonary complications, and the variables of pulmonary fibrosis, cavitary lesions, bronchitis, bronchiectasis and air trapping lesions will be evaluated and quantitatively compared in terms of the number of involved lobes in both groups.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Vasei hospital
Full name of responsible person
Fateme Alizadeh Mousavi
Street address
Sabzevar, Tohid Shahr Blvd., Vasi Medical Education Center
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4465 1300
Email
waseehospital@medsab.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice chancellor for research and technology
Full name of responsible person
Dr.Seyed Alireza Javadinia
Street address
Above the Tomb of Anonymous Martyrs, University Campus Building, Tawheed Shahr Blvd.,
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1300
Email
M.S@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellor for research and technology
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
Sabzevar University of Medical Sciences
Full name of responsible person
Fateme Alizadeh moosavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Vasei hospital; touhid shahr blvd;sabzevar town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873137
Phone
+98 51 4465 1300
Fax
Email
AlizademoosaviF01@medsab.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fateme Alizadeh moosavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Vasei hospital; touhid shahr blvd;sabzevar town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873137
Phone
+98 51 4465 1300
Fax
Email
AlizademoosaviF01@medsab.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fateme Alizadeh moosavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Vasei hospital; touhid shahr blvd;sabzevar town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873137
Phone
+98 51 4465 1300
Fax
Email
AlizademoosaviF01@medsab.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
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