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IRCT20120826010664N6 IRCT 2020-04-05 Tehran University of Medical Sciences Effect of hydroxychloroquine on prevention of covid-19 virus Effect of hydroxychloroquine on prevention of covid-19 virus infection among treatment staff in Arash hospital-A double-blind clinical trial 2020-03-29 anticipated 310 Complete https://irct.ir/trial/46603 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The randomized block allocation method was developed using Stata version 15 software by an epidemiologist. The block size was six. Allocation to treatment groups was conducted by an independent researcher (The epidemiologist). To conceal the process of random assignment, it is written on paper labels (random 10-digit codes) with no sequences and no specific framework that identifies the relevant treatment number and only the methodologist will be aware of the code. The labels will be attached to the drug packages in order of randomization. Drug packages will be arranged in a box according randomization list. When the physician declares a patient eligible, the methodologist will give him or her drug package. The person evaluating the outcomes is a third party who is unaware of the random allocation process and the type of treatment performed. The data will be analyzed by a statistician who is separate from the study process and unaware of all the processes performed, Blinding description: The drug and placebo, which have similar size, color, taste, and odor, are provided in completely similar containers by random assignment to both groups, so no patients will be informed of the specific treatment. The researcher is also unaware of the implications of the random allocation process and the type of treatment performed. The data will be analyzed by a statistical expert who is separate from the study process and unaware of all the processes performed. N/A Covid-19 prophylaxis. Intervention 1: Intervention group: Hydroxychloroquine 200 mg tablet of Amin Pharmaceutical, 400 mg daily and once a week for one to three months. (Based on the duration of corona virus epidemic). Intervention 2: Control group: placebo which is completely similar in form and taste to 200 mg hydroxychloroquine tablet and is manufactured by the same factory (Amin Pharmacy)is given.The dosage is two tablet daily , once a week for one to three months (based on duration of Corona virus epidemic in Tehran). No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Reihaneh Pirjani MD.
Arash Hospital, Baghdarnia Street, Farjam Street, Tehranpars , Tehran
Tehran Iran (Islamic Republic of) 1653915911 +98 21 7788 3288 pirjani@razi.tums.ac.ir Tehran University of Medical Sciences scientific Reihaneh Pirjani MD.
Arash Hospital, Baghdarnia Street, Farjam Street, Tehranpars , Tehran
Tehran Iran (Islamic Republic of) 1653915911 +98 21 7788 3288 pirjani@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Treatment staff who are in contact with patients who have at least 3 shift a week in the hospital consent to participate in the study. 18 years 60 years Both History of covid-19 virus infection clinical symptoms such as fever, nausea, dispenea and myalgia in the past two months history of underlying diseases hypersensitivity to hydroxychloroquine G6PD enzyme deficiency Prevention Placebo Intervention group: Hydroxychloroquine 200 mg tablet of Amin Pharmaceutical, 400 mg daily and once a week for one to three months. (Based on the duration of corona virus epidemic). Control group: placebo which is completely similar in form and taste to 200 mg hydroxychloroquine tablet and is manufactured by the same factory (Amin Pharmacy)is given.The dosage is two tablet daily , once a week for one to three months (based on duration of Corona virus epidemic in Tehran). Covid-19 infection. Timepoint: One, two and three months after starting the drug. Method of measurement: Covid-19 PCR test and clinical symptoms. Tehran University of Medical Sciences Approved 2020-03-19 Ethics committee of Tehran University of Medical Sciences Arash hospital, Baghdarnia st., Sardar Soleimani st, Tehran Tehran Iran (Islamic Republic of)