Protocol summary
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Study aim
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Evaluation of the efficacy and safety of colchicine in combination with standard treatment in patients with covid 19
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Design
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Clinical trial with control group, with parallel, double blind and randomized groups
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Settings and conduct
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This is a prospective, double-blind, randomized controlled clinical trial, and the patient, physician and evaluator will be unware of all steps
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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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
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Reason for update
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Registration of the second center according to the nationality of the project
Remove the placebo
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Acronym
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IRCT registration information
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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
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Registration date
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2020-05-18, 1399/02/29
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-04-04, 1399/01/16
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Expected recruitment end date
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2021-02-04, 1399/11/16
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Actual recruitment start date
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2020-03-26, 1399/01/07
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Actual recruitment end date
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2020-12-30, 1399/10/10
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Trial completion date
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2021-01-14, 1399/10/25
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Scientific title
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Investigation of the efficacy and safety of colchicine In combination with standard treatment on covid-19 patients: A clinical trial
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Public title
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Effect of colchicine in treatment of COVID-19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 70 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
200
Actual sample size reached:
152
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At the beginning of the study, patients will be assigned to one of the two divided groups with a random number table
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-04-02, 1399/01/14
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Ethics committee reference number
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IR.SBMU.NRITLD.REC.1399.018
Health conditions studied
1
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Description of health condition studied
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COVID-19
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19,virus identified
Primary outcomes
1
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Description
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-Clinical symptoms including fever, cough, shortness of breath
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Timepoint
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The first, third, seventh, fourteenth and 6-8 days after entering the study
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Method of measurement
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questionnaire
2
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Description
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pulmonary infiltration findings on CT scan
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Timepoint
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Two weeks later and 6-8 weeks later
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Method of measurement
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CT-scan
3
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Description
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o2sat at the time of hospitalization and discharge
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Timepoint
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The first, third, seventh, fourteenth and 6-8 days after entering the study
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Method of measurement
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Pulse Oximeter
4
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Description
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Laboratory symptoms (ESR, CRP, NLR, LDH, ferritin, D-dimer, CBC diff)
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Timepoint
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Hospitalization time and discharge time
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Method of measurement
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Blood test
Secondary outcomes
1
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Description
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Need hospitalization in icu
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Timepoint
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The first, third, seventh, fourteenth and 6-8 days after entering the study
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Method of measurement
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questionnaire
2
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Description
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Mortality
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Timepoint
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The first, third, seventh, fourteenth and 6-8 days after entering the study
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Method of measurement
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questionnaire
Intervention groups
1
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Description
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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
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Category
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Treatment - Drugs
2
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Description
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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).
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Yazd University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available