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IRCT20190804044429N5 IRCT 2021-02-18 Mazandaran University of Medical Sciences Colchicine effects on treatment of COVID-19 Efficacy and safety of colchicine on clinical improvement in patients with COVID-19: A randomized, double blind clinical trial 2021-02-22 anticipated 110 Complete https://irct.ir/trial/54385 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization using the block method by a person who is not related to the study. Packages containing the drug and placebo are completely similar in shape and color. Randomization of serial numbers of drug packages and placebo by a person who is not involved in the project according to randomized table. The number of the bottle corresponded with the number of the patient, Blinding description: This study is double blind. Outcome elevator and participant are blinded (double blind) and aware from grouping (intervention or placebo). The medicinal substance and placebo are completely similar in shape and color. 2-3 COVID-19 pneumonia. Intervention 1: Intervention group: Medication regimen including 250 mcg interferon beta 1 b subcutaneous injection every other day for at least 3 doses plus remdesivir 200 mg as first dose then 100 mg daily for 5 days with Colchicine tablet of Mofid company at dose of 2mg as loading dose then 1 mg daily for 7 days. Intervention 2: Control group: Patients with inclusion criteria who received therapeutic regimen of 250 mcg interferon beta 1 b as every other day subcutaneous injection for at least 3 doses and remdesivir 200 mg as first dose then 100 mg daily for 5 days. Yes - There is a plan to make this available What will be shared: IPD collected for the primary outcome measures are to be shared. When: The data will be available one year after publication To whom: Academic researchers, medical team and scientific institutes Conditions: Requests for sharing data should be sent to the person responsible for general inquiries. Where to obtain: Dr. Monireh Ghazaeian, Faculty of pharmacy, Mazandaran University of Medical Sciences. How to obtain: Person in charge of scientific study will reply to the request within 10 days. ghazaeianm@gmail.com Comments:
public ئخدهقثا لاشظشثهشد
Ibn Sina hospital, Pasdaran Blvd, Sari
Sari Iran (Islamic Republic of) 4816864193 +98 11 3334 3011 ghazaeianm@gmail.com Mazandaran University of Medical Sciences scientific Monireh Ghazaeian
Ibn Sina hospital, Pasdaran Blvd
Sari Iran (Islamic Republic of) 4816864193 +98 11 3334 3010 ghazaeianm@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria are adults over the age of 18 with a diagnosis of COVID-19 based on clinical criteria (presence of any symptoms of cough, shortness of breath, fever, and CT scan of the lung for evidence of involvement consistent with COVID-19 infection) or PCR and Had clinical symptoms of COVID-19 within two weeks 18 years no limit Both Pregnancy and lactation Severe hepatic insufficiency (Child-pugh C) Renal insufficiency (GFR less than 30 ml/min) Allergy history of colchicine Thrombocytopenia (Platelets less than 100,000 /mm3) Not consent U07.1 COVID-19, virus identified Treatment - Drugs Placebo Intervention group: Medication regimen including 250 mcg interferon beta 1 b subcutaneous injection every other day for at least 3 doses plus remdesivir 200 mg as first dose then 100 mg daily for 5 days with Colchicine tablet of Mofid company at dose of 2mg as loading dose then 1 mg daily for 7 days Control group: Patients with inclusion criteria who received therapeutic regimen of 250 mcg interferon beta 1 b as every other day subcutaneous injection for at least 3 doses and remdesivir 200 mg as first dose then 100 mg daily for 5 days. Respiratory rate. Timepoint: Before intervention and daily during the study. Method of measurement: physical exam. Blood oxygen saturation. Timepoint: Before intervention and daily during the study. Method of measurement: pulse oximeter. Fever recovery. Timepoint: Before intervention and daily during the study. Method of measurement: thermometer. Therapeutic regimen safety. Timepoint: Daily during the study. Method of measurement: Incidence of any side effects. CRP. Timepoint: before intervention and then three times weekly during the study. Method of measurement: CRP laboratory kite. Lymphocyte count. Timepoint: before intervention and then daily during the study. Method of measurement: Cell blood count test. Hospital stay duration. Timepoint: End of treatment. Method of measurement: Patient file. Mortality rate. Timepoint: Daily during the study. Method of measurement: patient file. Mazandaran University of Medical Sciences Approved 2021-02-16 Mazandaran University of Medical Sciences Ibn Sina Hospital, Pasdaran Blvd Sari Mazandaran Iran (Islamic Republic of)