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IRCT20130917014693N10 IRCT 2020-04-08 Shahid Beheshti University of Medical Sciences Evaluation the effects of Hydroxychloroquine administration for COVID-19 prophylaxis HOPEC Evaluation the efficacy and safety of Hydroxychloroquine administration for COVID-19 post exposure prophylaxis 2020-04-07 anticipated 100 Complete https://irct.ir/trial/46849 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, simple randomization method will be used. A randomized list will be generated by online randomization site. Households will be allocated to case or control group according to the generated list. Then cluster sampling will be done in each group. 3 COVID-19 pneumonia. Intervention 1: Intervention group: Participants receive Hydroxychloroquine (Amin Pharmaceutical company, Isfahan) at dose of 200 mg TDS up to 7 days. Intervention 2: Control group: Participants receive no medicines. Yes - There is a plan to make this available What will be shared: All potential data can be shared after blinding When: Six mounts after results published To whom: Researchers working in academic institutions Conditions: For research purposes and further analysis Where to obtain: Dr. Zahra Sahraei, Loghman Hakim Hospital, Kamali St, Makhsoos St, Tehran How to obtain: Official letter to the researchers Comments:
public Omidvar Rezaiemirghaed
Loghman Hakim Hospital, Kamali St, Makhsoos St
Tehran Iran (Islamic Republic of) 1333635445 +98 21 5541 9005 alisaffaei.ss@gmail.com Shahid Beheshti University of Medical Sciences scientific Zahra Sahraei
Valieasr St, Niyayesh Highway, Shahid Beheshti University of Medical Sciences, School of Pharmacy
Tehran Iran (Islamic Republic of) 1991953381 +98 21 8820 0118 zahra.sahraei@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age over 18 years old Close contact with COVID-19 patient at least in past 4 days sign the informed consent form to participate in study 18 years no limit Both Pervious case of COVID-19 Current case of COVID-19 Presenting influenza like symptoms (fever, cough, and sore throat) in last 30 days Travel history in last 14 days Lactation and pregnancy History of arrhythmia Drug allergy history Favism history Chronic liver disease Chronic kidney disease Retinopathy history Weight under 40 kg Patients who are receiving arritmogenica medicines U07.2 COVID-19, virus not identified Prevention N/A Intervention group: Participants receive Hydroxychloroquine (Amin Pharmaceutical company, Isfahan) at dose of 200 mg TDS up to 7 days. Control group: Participants receive no medicines. Fever. Timepoint: Daily. Method of measurement: Thermometer. Cough. Timepoint: Daily. Method of measurement: Questionnaire. Dyspnea. Timepoint: Daily. Method of measurement: Questionnaire. Sore throat. Timepoint: Daily. Method of measurement: Questionnaire. Myalgia. Timepoint: Daily. Method of measurement: Questionnaire. Disease severity. Timepoint: At end of the study. Method of measurement: Clinical scoring for disease severity. Death. Timepoint: Day 7, day 14, and day 28. Method of measurement: Observation. Adverse reactions. Timepoint: Daily. Method of measurement: Observation. Shahid Beheshti University of Medical Sciences Approved 2020-04-06 Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical Sciences 3 rd floor, School of Medicine, Evin St, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)