Effects of colchicine on persistent dyspnea and pulmonary fibrosis of COVID-19 patients after hospital discharge
Design
40 patients with history of persistent dyspnea after COVID19 infection are divided into two groups. 20 patients receiving colchicine and the other 20 receiving placebo to compare effect of colchicine onpersistent dyspnea and pulmonary fibrosis
sampling: sampling was non randomized convenience sampling
double blinded clinical trial phase 2
Settings and conduct
COVID19 patients 2 months after discharging from hospital were assessed by an internist based on UCSD form for dyspnea and lung CT scan .patients with persistent dyspnea and/ or pulmonary fibrosis were enrolled in control (placebo)and treatment(colchicine) group randomly .patients and investigators were blinded .a reassessment was done after 1 and then 6 month
Participants/Inclusion and exclusion criteria
inclusion criteria: history of COVID19 infection confirmed with CT scan or/and positive PCR
exclusion criteria: history of taking colchicine. pregnancy. history of allergic reaction to colchicine. taking immunosuppressant drugs. history of chronic dyspnea. non consent
Intervention groups
40 patients with history of COVID19 infection are divided into two groups. 20 patients receiving colchicine and the other 20 receiving placebo to compare effect of colchicine on persistent dyspnea
Main outcome variables
persistent dyspnea and/ or pulmonary fibrosis in COVID-19 patients at least 2 month after discharge from hospital and clinical effects of colchicine in treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200707048047N1
Registration date:2021-03-27, 1400/01/07
Registration timing:registered_while_recruiting
Last update:2021-03-27, 1400/01/07
Update count:0
Registration date
2021-03-27, 1400/01/07
Registrant information
Name
Masoumeh Moallem
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2611 6628
Email address
masoumehmoallem@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
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
Effects of colchicine on persistent dyspnea and pulmonary fibrosis of COVID-19 patients after hospital discharge
Public title
colchicine effect on persistent dyspnea in COVID19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
history of covid19 infection confirmed with lung lesion in CT scan and/or positive PCR
Exclusion criteria:
history of taking colchicine..history of ipf.non consent
pregnancy
history of allergic reaction to colchicine
immunosuppressive drug consumption
history of chronic dyspnea or dyspnea on exertion due to underlying diseases
non consent in any stage of study
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
in this study both control and treatment group receive supportive treatment. drug and placebo are packed in packages and are blindly distributed between patients.principle investigators and health care providers were blinded in this study
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad Tehran Medical Sciences University - Pharmacy and Pharmaceutical Branches Faculty
Street address
خاقانی
City
tehran
Province
Tehran
Postal code
1916893813
Approval date
2021-01-31, 1399/11/12
Ethics committee reference number
IR.IAU.PS.REC.1399.255
Health conditions studied
1
Description of health condition studied
COVID19
ICD-10 code
U07.1
ICD-10 code description
U07.1
Primary outcomes
1
Description
نمره تنگی نفس بر اساس پرسش نامه UCSD
Timepoint
Before intervention,1and6months after intervention
Method of measurement
UCSD questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients with history of Covid19 infection with persistent dyspnea and pulmonary fibrosis receive colchicine 0.5mg BID for 3 days and then 0.5 mg daily for 1 month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Boali hospital Tehran
Full name of responsible person
Masoumeh moallem
Street address
Boali hospital,Damavand st,Imam Hosein sq,Tehran
City
Tehran
Province
Tehran
Postal code
1711734365
Phone
+98 21 3334 8036
Email
masoumehmoallem@gmail.com
Web page address
http://bouali.iautmu.ac.ir/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Khoshdel
Street address
khaghani
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
pezeshkitehran.8@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
20
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
Islamic Azad University
Full name of responsible person
masoumeh moallem
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Dastgerdi
City
Tehran
Province
Tehran
Postal code
1918613511
Phone
+98 21 2222 3567
Email
masoumehmoallem@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shimaa Mosalanejad
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Khaje abdollah
City
tehran
Province
Tehran
Postal code
1661645320
Phone
+98 21 2232 2780
Email
shimaamosalanejad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoumeh Moallem
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Tehran
City
Tehran
Province
Tehran
Postal code
1918613511
Phone
+98 21 2222 3567
Email
masoumehmoallem@gmail.com
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