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IRCT20200325046854N2 IRCT 2021-05-03 Iran University of Medical Sciences Colchicine in combination with infliximb compared with infliximb in the treatment of patients with Covidian 19 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 2021-03-16 anticipated 70 Complete https://irct.ir/trial/55085 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, 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. 2-3 COVID-19. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Some of the information including the primary or secondary outcome can be shared. When: 8 months after the end of the study To whom: Medical specialists Conditions: 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. Where to obtain: Maryam Farasatinasab, Assistant Professor of Clinical Pharmacy, Iran University of Medical Sciences. Email: maryfarasati@gmail.com How to obtain: At the formal request to the person in charge of study Comments:
public Maryam Farasatinasab
Firoozgar Hospital, Beh Afarin St., Karim Khan Zand St.,Valiasr Square
Tehran Iran (Islamic Republic of) 1593747811 009882141558 maryfarasati@gmail.com Iran University of Medical Sciences scientific Maryam Farasatinasab
Firoozgar Hospital, Beh Afarin St.,Karim Khan Zand St.,Valiasr Square
Tehran Iran (Islamic Republic of) 1593747811 +98 21 8214 1558 maryfarasati@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 85 years Both 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 U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs 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. 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. Evaluation of clinical symptoms. Timepoint: Before the intervention and daily during the intervention. Method of measurement: Clinical evaluation of the patient/ Questionnaire. Evaluation of pulmonary CT scan changes. Timepoint: Before the intervention and every other day during the intervention. Method of measurement: Pulmonary CT scan. Evaluation of TNF-Alfa level trend. Timepoint: Before receiving the drug and one week after treatment. Method of measurement: Elisa Test. Evaluation of Interferon Gamma level trend. Timepoint: Before receiving the drug and one week after treatment. Method of measurement: Elisa test. Evaluation of CRP level trend. Timepoint: Before receiving the drug and one week after treatment. Method of measurement: CRP Test Quantitative/Blood sample. Evaluation of ESR level trend. Timepoint: Before receiving the drug and one week after treatment. Method of measurement: Westergren method/ Blood sample. Evaluation of Ferritin level trend. Timepoint: Before receiving the drug and one week after treatment. Method of measurement: Electrochemiluminescence immunoassay. Evaluation of Adverse Drug Reaction. Timepoint: Daily from the beginning of the intervention. Method of measurement: Naranjo Adverse Drug Reaction Probability Questionnaire. Evaluation of IL-6 inflammatory factor level trends. Timepoint: Before the intervention and one week after the intervention. Method of measurement: Elisa test. Evaluation of lymphopenia. Timepoint: Before the intervention and daily during the intervention. Method of measurement: CBC diff test. Iran University of Medical Sciences Approved 2021-03-16 Iran University of Medical Sciences Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)