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Protocol summary
Patients in the Colchicine group take half a milligram a day for one to three days, and one milligram a day for the next 12 days in addition to standard treatment, patients in the control group take placebo orally once a day for one to three days and orally twice a day for the next 12 days in addition to standard treatment
Patients in the Colchicine group take half a milligram a day for one to three days, and one milligram a day for the next 12 days in addition to standard treatment, patients in the control group take standard treatment
Patients in the Colchicine group take half a milligram a day for one to three days, and one milligram a day for the next 12 days in addition to standard treatment, patients in the control group take placebo orally once a day for one to three days and orally twice a day for the next 12 days in addition to standard treatment
بیماران گروه کلشی سین، در روز های یک تا سه، روزی نیم میلیگرم و برای 12 روز بعدی، روزی یک میلی گرم کلشی سین به صورت خوراکی در کنار درمان استاندارداستفاده می کنند. بیماران گروه کنترل، در کنار درمان استاندارد، در روز های یک تا سه، روزانه یک و برای 12 روز بعد روزی دو مرتبه به صورت خوراکی از قرص پلاسبو استفاده می کنند
بیماران گروه کلشی سین، در روز های یک تا سه، روزی نیم میلیگرم و برای 12 روز بعدی، روزی یک میلی گرم کلشی سین به صورت خوراکی در کنار درمان استاندارداستفاده می کنند. بیماران گروه کنترل، درمان استاندارد، استفاده می کنند
بیماران گروه کلشی سین، در روز های یک تا سه، روزی نیم میلیگرم و برای 12 روز بعدی، روزی یک میلی گرم کلشی سین به صورت خوراکی در کنار درمان استاندارداستفاده می کنند. بیماران گروه کنترل، در کنار درمان استاندارد، در روز های یک تا سه، روزانه یک و برای 12 روز بعد روزی دو مرتبه به صورت خوراکی از قرص پلاسبو استفاده می کنند
General information
Used
Not used
usednused
empty
152
152
empty
2020-03-26, 1399/01/07
2020-03-26 00:00:00
empty
2020-12-30, 1399/10/10
2020-12-30 00:00:00
empty
2021-01-14, 1399/10/25
2021-01-14 00:00:00
empty
Registration of the second center according to the nationality of the project
Remove the placebo
Registration of the second center according to the nationality of the project Remove the placebo
empty
ثبت مرکز دوم با توجه به ملتی سنتر بودن طرح
حذف پلاسبو
ثبت مرکز دوم با توجه به ملتی سنتر بودن طرح حذف پلاسبو
Recruitment centers
#1
Name of recruitment center - English: NRITLD. Masih daneshvari hospital
Name of recruitment center - Persian: بیمارستان مسیح دانشوری
Full name of responsible person - English: Guitti Pourdowlat
Full name of responsible person - Persian: گیتی پوردولت
Street address - English: Masih daneshvari hospital, shahid bahonar ave. tehran. Iran
Street address - Persian: ایران، تهران، خیابان شهید باهنر، دربند، بیمارستان مسیح دانشوری
City - English: tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 19569-44413
Phone: +98 21 2712 2000
Fax:
Email: pourdowlat_g@yahoo.com
Web page address:
Name of recruitment center - English: NRITLD. Masih daneshvari hospital Name of recruitment center - Persian: بیمارستان مسیح دانشوری Full name of responsible person - English: Guitti Pourdowlat Full name of responsible person - Persian: گیتی پوردولت Street address - English: Masih daneshvari hospital, shahid bahonar ave. tehran. Iran Street address - Persian: ایران، تهران، خیابان شهید باهنر، دربند، بیمارستان مسیح دانشوری City - English: tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 19569-44413 Phone: +98 21 2712 2000 Fax: Email: pourdowlat_g@yahoo.com Web page address:
Protocol summary
Study aim
Evaluation of the efficacy and safety of colchicine in combination with standard treatment in patients with covid 19
Design
Clinical trial with control group, with parallel, double blind and randomized groups
Settings and conduct
This is a prospective, double-blind, randomized controlled clinical trial, and the patient, physician and evaluator will be unware of all steps
Participants/Inclusion and exclusion criteria
Entry:Age 18 to 70 years; Detection of COVID-19 in the last 24 to 48 hours; o2sat <93% or RR> 24 or Pao2 / Fio2 <300; Covid-19 patients hospitalized with hospital indications according to the guideline of the country that has pulmonary infiltration in CT scan; No consumption colchicine during the last week ;Exclusion: Patients with a history of chronic Crohn's or colitis, diarrhea, or chronic malabsorption; History of cirrhosis, hepatitis and severe liver disease; Patients currently taking colchicine for other uses, such as gout or Mediterranean fever; Patients with a history of allergic reactions or allergies to colchicine; Patients receiving chemotherapy for cancer
Intervention groups
Patients in the Colchicine group take half a milligram a day for one to three days, and one milligram a day for the next 12 days in addition to standard treatment, patients in the control group take standard treatment
Main outcome variables
clinical symptoms including fever, cough, shortness of breath;laboratory symptoms (ESR, CRP, NLR, LDH, ferritin, D-dimer, CBC diff); o2sat at the time of hospitalization and discharge; finding of pulmonary infiltration in CT scan
General information
Reason for update
Registration of the second center according to the nationality of the project
Remove the placebo
Acronym
IRCT registration information
IRCT registration number:IRCT20190810044500N5
Registration date:2020-05-18, 1399/02/29
Registration timing:registered_while_recruiting
Last update:2021-04-12, 1400/01/23
Update count:1
Registration date
2020-05-18, 1399/02/29
Registrant information
Name
Fatemeh Saghafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3419
Email address
f.saghafi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-04, 1399/01/16
Expected recruitment end date
2021-02-04, 1399/11/16
Actual recruitment start date
2020-03-26, 1399/01/07
Actual recruitment end date
2020-12-30, 1399/10/10
Trial completion date
2021-01-14, 1399/10/25
Scientific title
Investigation of the efficacy and safety of colchicine In combination with standard treatment on covid-19 patients: A clinical trial
Public title
Effect of colchicine in treatment of COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
- Age 18 to 70 years
- Detection of COVID-19 in the last 24 to 48 hours
- Candidate for hospitalization (o2sat <93% or RR> 24 or Pao2 / Fio2 <300)
- COVID-19 patients hospitalized with hospital indications according to the guideline of the country that has pulmonary infiltration in CT scan
-Not being pregnant and not becoming pregnant until 30 days after the end of the study
- No consumption of colchicine during the last week ( due to the half-life of 20-40 hours of the drug)
- Outpatients with pulmonary infiltration on CT scan
Exclusion criteria:
Patients with a history of Crohn or Ulcerative colitis, diarrhea, or chronic malabsorption
Neuromuscular diseases
GFR less than 30 ml per minute
History of cirrhosis, hepatitis and severe liver disease
Patients receiving chemotherapy for cancer
Patients currently taking colchicine for other uses, such as gout or Mediterranean fever
Patients with a history of allergic reactions or allergies to colchicine
Pregnancy and lactation
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
200
Actual sample size reached:
152
Randomization (investigator's opinion)
Randomized
Randomization description
At the beginning of the study, patients will be assigned to one of the two divided groups with a random number table
Blinding (investigator's opinion)
Double blinded
Blinding description
All stages will be covered by the patient, the treating physician and the evaluators. In this way, the first executor of the sequence plan specifies the allocation of people according to the order of admission of sick people to the study and pours the drugs into one-packets for consumption for two weeks and identifies them with A or B codes. Then, the drugs suitable for each person are identified according to the above explanations and placed in special envelopes and delivered to patients. One group is given a placebo and standard treatment and the other group is given a colchicine and standard treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Committee for Ethics in Biomedical Research
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran
City
tehran
Province
Tehran
Postal code
8915173143
Approval date
2020-04-02, 1399/01/14
Ethics committee reference number
IR.SBMU.NRITLD.REC.1399.018
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
-Clinical symptoms including fever, cough, shortness of breath
Timepoint
The first, third, seventh, fourteenth and 6-8 days after entering the study
Method of measurement
questionnaire
2
Description
pulmonary infiltration findings on CT scan
Timepoint
Two weeks later and 6-8 weeks later
Method of measurement
CT-scan
3
Description
o2sat at the time of hospitalization and discharge
Timepoint
The first, third, seventh, fourteenth and 6-8 days after entering the study
The first, third, seventh, fourteenth and 6-8 days after entering the study
Method of measurement
questionnaire
2
Description
Mortality
Timepoint
The first, third, seventh, fourteenth and 6-8 days after entering the study
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: Receive 0.5 mg of colchicine until the third day and 12 days later one mg plus standard treatment including 200 mg hydroxychloroquine daily
Category
Treatment - Drugs
2
Description
Control group: From the first to the third day, two tablets of placebo and for the next 12 days, one daily dose in addition to the standard treatment (200 mg hydroxychloroquine daily).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoghi Hospital
Full name of responsible person
Nadia Soltani gerdefaramarzi
Street address
Yazd, Shahid Ghandi Blvd., Ibn Sina St., Shahid Sadoughi Hospital
City
Yazd
Province
Yazd
Postal code
8915857958
Phone
+98 35 3822 4000
Email
nadia.slt75@gmail.com
Web page address
https://web.ssu.ac.ir/index.aspx?lang=1&sub=16
2
Recruitment center
Name of recruitment center
NRITLD. Masih daneshvari hospital
Full name of responsible person
Guitti Pourdowlat
Street address
Masih daneshvari hospital, shahid bahonar ave. tehran. Iran
City
tehran
Province
Tehran
Postal code
19569-44413
Phone
+98 21 2712 2000
Email
pourdowlat_g@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Bahonar Square, the central building of Yazd University of Medical Sciences
City
Yazd
Province
Yazd
Postal code
9856783459
Phone
+98 35 3146 2056
Email
mmirzaei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Nadia Soltani Gerdefaramarzi
Position
University student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Unit 701,Floor7,Negar complex, Negaran alley, Jomhouri Blvd
City
Yazd
Province
Yazd
Postal code
۴۵۵۸۷۷۰۰۴۴
Phone
+98 35 3521 5048
Email
nadia.slt75@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr.Fateme Saghafi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of Medical Sciences, Shohada gomnam Blvd
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3419
Email
saghafi.fa@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Nadia Soltani Gerdefaramarzi
Position
University student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Unit 701,Floor7,Negar complex, Negaran alley, Jomhouri Blvd
City
Yazd
Province
Yazd
Postal code
۴۵۵۸۷۷۰۰۴۴
Phone
+98 35 3521 5048
Email
nadia.slt75@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