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IRCT20200421047153N1 IRCT 2020-12-19 Islamic Azad University Hydroxychloroquine prophylaxis in preventing the severe forms of Covid-19 A Community Trial to examine the effect of hydroxychloroquine prophylaxis in preventing the sever forms of Covid-19 in asymptomatic people 2020-07-04 anticipated 1000 Complete https://irct.ir/trial/47337 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Random allocation will be used in this trial based on balance block randomization and by 4:1 blocks. The randomization table was designed by the epidemiologist for a sample size of 1000 people according to the two study arms A and B (intervention and placebo). The balanced blocks were selectively four so, A and B were repeated in these blocks. The codes listed in the table from 1 to 1000 are unique to each participant. At the time of performance by referring to this list,a package of 10 pills (medicine or placebo) coded by a pharmaceutical expert is given to the person . The software used is SPSS18, Blinding description: Individuals are divided in groups A or B according to the prepared sequence . The codes listed in the table are unique to each participant . After completing, the sequence will be given to the manufacturer of the drug and placebo . The company puts drugs and placebo into envelopes according to each person's code and provides the researcher with a label of person's code written on them.Therefore, participant and who will assess patients in follow-up visits will be unaware of each number belongs to which groups(A or B). 3 Covid-19. Intervention 1: Intervention group (500 individuals): 800 mg hydroxychlorine tablet i two separate doses daily for one week and then 200 mg tablet daily for 6 weeks. Intervention 2: Control group: 500 people placebo group 800 mg placebo tablet in two separate doses daily for one week and then 200 mg tablet daily for 6 weeks. 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 Termeh Tarjoman
Amir-al-momenin hospital- Shirmohammadi Ave-Naziabad
Tehran Iran (Islamic Republic of) 1811694784 +98 21 5534 6262 ttarjoman@iautmu.ac.ir Islamic Azad University scientific Termeh Tarjoman
Amir-al-momenin hospital ,shirmohammadi Ave.Nazi abad
Tehran Iran (Islamic Republic of) 1811694784 +98 21 5534 6262 t.tarjoman@iautmu.ac.ir Islamic Azad University Iran (Islamic Republic of) 18-65 years old No symptoms of corona and no positive corona test The desire to participate in the study No symptoms of disease at the time of admission No positive test 18 years 65 years Both History of allergy to hydroxychloroquine Contraindications for drug use include previous history of retinopathy or G6PD, LONG QT SYNDROME, porphyry Positive HIV patients Patients with autoimmune diseases (lupus-rheumatoid arthritis) BMI >40 Diabetic CKD Using medications with contraindication to use hydroxychloroquine U07.1 COVID-19, virus identified Prevention Prevention Intervention group (500 individuals): 800 mg hydroxychlorine tablet i two separate doses daily for one week and then 200 mg tablet daily for 6 weeks Control group: 500 people placebo group 800 mg placebo tablet in two separate doses daily for one week and then 200 mg tablet daily for 6 weeks Incidence of mild type covid-19 (fever - cough - dyspnea- positive PCRtest)-CDC. Timepoint: weekly for 10 weeks. Method of measurement: phone interview -medical record review. Incidence of severe type (dyspnea - chest pain or pressure - decreased level of consciousness - bruising of the lips and face and positive PCR test) based on CDC definition. Timepoint: weekly for 10 weeks. Method of measurement: phone interview -medical record review. Hospitalization need. Timepoint: Weekly to 10 weeks. Method of measurement: phone interview -medical record review. Mechanical ventilation need. Timepoint: Weekly to 10 weeks. Method of measurement: phone interview -medical record review. Deaths. Timepoint: Weekly to 10 weeks. Method of measurement: phone interview -medical record review. Islamic Azad University of Medical Sciences Approved 2020-04-09 Ethics committee of Azad University of Medical Sciences l Scien ces No16,west Goleyakh Ave.Gholhak Ave,Shariati Tehran Tehran Iran (Islamic Republic of)