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IRCT20200513047426N1 IRCT 2020-06-27 Boushehr University of Medical Sciences The prophylactic effect of oral hydroxy-chloroquine in close contacts of COVID-19 patients COVID The prophylactic effect of oral hydroxy-chloroquine in close contacts of COVID-19 patients 2020-06-21 anticipated 500 Complete https://irct.ir/trial/48236 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Close contact with a person with COVID-19 who has been diagnosed positive with a definitive test can be known.sample size can be measured by following formula: P ̅=(P_1+P_2)/2 n=(z_(1-α/2) √(2P ̅(1-P ̅ ) )+z_(1-β) √(P_1 (1-P_1 )+P_2 (1-P_2 ) ))/(P_1-P_2 )^2 sample size=500 person Restricted randomization by Random allocation rule, Blinding description: Participants, main researchers, health care personnel (physicians, nurses, students, etc.) who are responsible for patients care, data collection, and those who evaluate the outcome. Of course, the patient is informed consciously, but is not aware of the nature of the medication he is taking, and assumes that all participants are taking the same medication. 3 Covid19. Intervention 1: Intervention group: Cases of this group are treated with preventive treatment of hydroxychloroquine as follows.1-hydroxychloroquine 400 mg tablet once on the first night at 22:002- hydroxychloroquine 200 mg tablet once a night for 5 nights at 22:00It should be noted that patients will be monitored directly to prevent the effects of disruptive factors. Intervention 2: Control group: The cases of this group are treated with preventive treatment of placebo for 6 days, which are used orally once a day at 22:00.The control group also uses vitamin B1 tablets, which, in terms of drug form, color and odor, are similar to hydroxychloroquine. Yes - There is a plan to make this available What will be shared: not When: not To whom: not Conditions: not Where to obtain: not How to obtain: not Comments:
public Ramin Rezaee
Moallem Ave
Boshehr Iran (Islamic Republic of) 7518759577 +98 77 3345 2227 Drrezaee.ramin@yahoo.com Boushehr University of Medical Sciences scientific Dr.Ramin Rezaee
Moallem Ave
Boshehr Iran (Islamic Republic of) 7518759577 +98 77 3345 2227 Drrezaee.ramin@yahoo.com Boushehr University of Medical Sciences Iran (Islamic Republic of) Close contact with a person with COVID-19 who has been diagnosed positive with a definitive test. Close contact: contact, hand shake and talking at least once in the last 2 days for less than 2 meters with COVID-19 patient who have been diagnosed positive with a definitive test. Family, friends, relatives who have been in the same place for a period of 4 hours or more in the last 2 days with a COVID-19 patient who have been diagnosed with a definitive test . Medical staff, including physicians, nurses, midwives, and service personnel which have been in contact with COVID-19 patient who has been diagnosed with a definitive test in the past three days. no limit no limit Both Lack of satisfaction from entered persons The presence of diseases or conditions in which the use of hydroxychloroquine is as a contraindication, such as patients with heart failure who take QT prolonging drugs are as contraindications. Existence of distorting factors during the implementation of clinical trial.+ During the study, people should be in home quarantine . + Do not Excessive use of vitamins and medications.+ has Meals like family’s.+has Regular sleep cycle Complications of hydroxychloroquine based on the Iranian rheumatology association include the following:1- Nausea, decreased appetite and diarrhea 2- Skin allergies 3- Skin discoloration 4- Ocular sensitivity 5- Headache 6- Rush B34.2 Coronavirus infection, unspecified Prevention Placebo Intervention group: Cases of this group are treated with preventive treatment of hydroxychloroquine as follows.1-hydroxychloroquine 400 mg tablet once on the first night at 22:002- hydroxychloroquine 200 mg tablet once a night for 5 nights at 22:00It should be noted that patients will be monitored directly to prevent the effects of disruptive factors. Control group: The cases of this group are treated with preventive treatment of placebo for 6 days, which are used orally once a day at 22:00.The control group also uses vitamin B1 tablets, which, in terms of drug form, color and odor, are similar to hydroxychloroquine. Percentage of people who have not been diagnosed with Covid19 after co-administration of hydroxychloroquine. Timepoint: The end of study. Method of measurement: Diagnostic COVID-19 Kits. Boushehr University of Medical Sciences Approved 2020-04-05 Ethics committee of Boshehe University of Medical Sciences Moallem Ave Boshehr Boushehr Iran (Islamic Republic of)