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IRCT20190810044500N5 IRCT 2020-05-18 Yazd University of Medical Sciences Effect of colchicine in treatment of COVID-19 Investigation of the efficacy and safety of colchicine In combination with standard treatment on covid-19 patients: A clinical trial 2020-04-04 anticipated 200 Complete https://irct.ir/trial/46867 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 COVID-19. Intervention 1: 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. Intervention 2: 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). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Nadia Soltani Gerdefaramarzi
Unit 701,Floor7,Negar complex, Negaran alley, Jomhouri Blvd
Yazd Iran (Islamic Republic of) ۴۵۵۸۷۷۰۰۴۴ +98 35 3521 5048 nadia.slt75@gmail.com Yazd University of Medical Sciences scientific Dr.Fateme Saghafi
Shahid Sadoughi University of Medical Sciences, Shohada gomnam Blvd
Yazd Iran (Islamic Republic of) 8915173143 +98 35 3820 3419 saghafi.fa@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) - 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 18 years 70 years Both 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 U07.1 COVID-19,virus identified Treatment - Drugs Placebo 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 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). -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. Pulmonary infiltration findings on CT scan. Timepoint: Two weeks later and 6-8 weeks later. Method of measurement: CT-scan. O2sat at the time of hospitalization and discharge. Timepoint: The first, third, seventh, fourteenth and 6-8 days after entering the study. Method of measurement: Pulse Oximeter. Laboratory symptoms (ESR, CRP, NLR, LDH, ferritin, D-dimer, CBC diff). Timepoint: Hospitalization time and discharge time. Method of measurement: Blood test. Need hospitalization in icu. Timepoint: The first, third, seventh, fourteenth and 6-8 days after entering the study. Method of measurement: questionnaire. Mortality. Timepoint: The first, third, seventh, fourteenth and 6-8 days after entering the study. Method of measurement: questionnaire. Yazd University of Medical Sciences Approved 2020-04-02 National Committee for Ethics in Biomedical Research Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran tehran Tehran Iran (Islamic Republic of)