Evaluation of efficacy and safety of colchicine in combination with infliximb compared with infliximb in the treatment of patients with Covidian 19: a randomized clinical trial
Determination of efficacy and safety of colchicine with Infliximab in comparison with Infliximab in the treatment of patients with Covid 19
Design
The study will be open label and random. Block randomization will be used for randomization. The minimum number of patients in each group will be 35.
Patients are randomly divided into two groups (9 blocks of 4 in each group) by ABAB (blocks with size 4) blocking method and will be entered by census in patients with inclusion criteria.
Settings and conduct
Group 1: Patients with COVID-19 with inclusion criteria admitted to Firoozgar Hospital will be treated with 1 mg of colchicine (for 7 days) and infliximab (single dose of 300 mg on the first day of treatment) and recommended treatments for COIVD-19.
Group 2: patients will receive standard treatment with Infliximab (single dose of 300 mg on the first day).
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Patients with the common type of Novel Coronavirus Pneumonia (NCP) (with risk factors including increased pulmonary lesions with or without fever) and critical progression of NCP between the ages of 18 and 85 with increased IL-6 levels
Exclusion criteria:
1. Patients participating in other clinical studies
2. Pregnant or lactating women
3. Consumers of immunomodulators to prevent transplant rejection or other cases
4. Sensitivity to any of the medicinal compounds
5. Patients with active pulmonary tuberculosis, specific bacterial and fungal infections; Patients with malignancy
Intervention groups
Group A: Infliximab+ Standard Treatment+ Colchicine
Group B: Infliximab+ Standard Treatment
Main outcome variables
Primary Outcomes:
1. Evaluation of clinical symptoms
2. Evaluation of CT scan changes
3. Evaluation of lymphopenia
4. Evaluation of IL-6 level
Secondary Outcomes:
1. Evaluation of TNF-α , Interferon Gamma, CRP, ESR and Ferritin levels
2. Evaluation of drug side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200325046854N2
Registration date:2021-05-03, 1400/02/13
Registration timing:registered_while_recruiting
Last update:2021-05-03, 1400/02/13
Update count:0
Registration date
2021-05-03, 1400/02/13
Registrant information
Name
Maryam Farasatinasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4460 4800
Email address
maryfarasati@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-16, 1399/12/26
Expected recruitment end date
2021-05-05, 1400/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy and safety of colchicine in combination with infliximb compared with infliximb in the treatment of patients with Covidian 19: a randomized clinical trial
Public title
Colchicine in combination with infliximb compared with infliximb in the treatment of patients with Covidian 19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with the common type of Novel Coronavirus Pneumonia (NCP) (at high risk) and other severe cases of newly diagnosed coronavirus pneumonia between the ages of 18 and 85 with an increase in IL-6 levels if the patient or his or her judge agrees to participate. Study and after signing the informed consent entered the study. Definition of clinical cases of the novel Coronavirus Pneumonia (NCP) :. 1. Specifications with NCP (with serious risk factors): Contains lung lesions based on common clinical signs of NCP with or without fever. 2. NCP critical patient.
Exclusion criteria:
1. Patients participating in other clinical studies 2. Pregnant or lactating women; 3. Patients receiving immunomodulatory drugs to prevent graft rejection or other cases; 4. Allergy to any of the drug compounds; 5. Patients with active pulmonary tuberculosis, with specific bacterial and fungal infections; Patients with malignancy
Age
From 18 years old to 85 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two groups by block randomization with size of 4. Random number table is used as a randomization tool.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-03-16, 1399/12/26
Ethics committee reference number
IR.IUMS.REC.1399.1454
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
Evaluation of clinical symptoms
Timepoint
Before the intervention and daily during the intervention
Method of measurement
Clinical evaluation of the patient/ Questionnaire
2
Description
Evaluation of pulmonary CT scan changes
Timepoint
Before the intervention and every other day during the intervention
Method of measurement
Pulmonary CT scan
Secondary outcomes
1
Description
Evaluation of TNF-Alfa level trend
Timepoint
Before receiving the drug and one week after treatment
Method of measurement
Elisa Test
2
Description
Evaluation of Interferon Gamma level trend
Timepoint
Before receiving the drug and one week after treatment
Method of measurement
Elisa test
3
Description
Evaluation of CRP level trend
Timepoint
Before receiving the drug and one week after treatment
Method of measurement
CRP Test Quantitative/Blood sample
4
Description
Evaluation of ESR level trend
Timepoint
Before receiving the drug and one week after treatment
Method of measurement
Westergren method/ Blood sample
5
Description
Evaluation of Ferritin level trend
Timepoint
Before receiving the drug and one week after treatment
Method of measurement
Electrochemiluminescence immunoassay
6
Description
Evaluation of Adverse Drug Reaction
Timepoint
Daily from the beginning of the intervention
Method of measurement
Naranjo Adverse Drug Reaction Probability Questionnaire
7
Description
Evaluation of IL-6 inflammatory factor level trends
Timepoint
Before the intervention and one week after the intervention
Method of measurement
Elisa test
8
Description
Evaluation of lymphopenia
Timepoint
Before the intervention and daily during the intervention
Method of measurement
CBC diff test
Intervention groups
1
Description
Intervention group: Infliximab+ Standard Treatment+ Colchicine؛ Patients in this group were treated concomitantly with 1 mg of colchicine (for 7 days) with infliximab (single dose of 300 mg on the first day of treatment) and recommended treatments for COIVD-19 (standard treatment provided in the latest national guideline to COVID-19 disease).Currently the standard national guideline includes: 200 mg hydroxychloroquine or 250 mg chloroquine (two tablets every 12 hours on the first day and one tablet every 12 hours for at least 7 days and up to 14 days) + kaletra (lupinavir / ritonavir) 200/50 mg every 12 hours 2 tablets for a minimum of 7 days and a maximum of 14 days or tablets (Atazanavir / Ritonavir) 300/100 mg/day with food for a minimum of 7 days and a maximum of 14 days.
Category
Treatment - Drugs
2
Description
Control group: Infliximab+ Standard Treatment؛ In addition to standard treatment, patients in this group will receive infliximab (single dose of 300 mg on the first day).Currently the standard national guideline includes: 200 mg hydroxychloroquine or 250 mg chloroquine (two tablets every 12 hours on the first day and one tablet every 12 hours for at least 7 days and up to 14 days) + kaletra (lupinavir / ritonavir) 200/50 mg every 12 hours 2 tablets for a minimum of 7 days and a maximum of 14 days or tablets (Atazanavir / Ritonavir) 300/100 mg/day with food for a minimum of 7 days and a maximum of 14 days.
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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Some of the information including the primary or secondary outcome can be shared.
When the data will become available and for how long
8 months after the end of the study
To whom data/document is available
Medical specialists
Under which criteria data/document could be used
In case of a written request to the study authorities and while preserving the copyright, part of the information including the primary or secondary outcome will be made available to the applicants.
From where data/document is obtainable
Maryam Farasatinasab, Assistant Professor of Clinical Pharmacy, Iran University of Medical Sciences.
Email: maryfarasati@gmail.com
What processes are involved for a request to access data/document
At the formal request to the person in charge of study