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IRCT20200424047184N1 IRCT 2021-01-16 Islamic Azad University Hydroxychloroquine in prevention of sever forms of COVID-19 in healthcare workers A Field Trial to examine the effect of hydroxychloroquine prophylaxis in preventing the sever forms of COVID-19 infection in asymptomatic healthcare workers (A double blind placebo controlled study) 2020-04-03 anticipated 400 Complete https://irct.ir/trial/47775 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: Duration of the study (7 weeks of intervention and 10 weeks of follow up) is longer than the previous studies. Also the protocol of the study is different and is somehow similar to what is being used in malaria prophylaxis, Randomization description: Using Balanced- Blocked Randomization, subjects are randomly assigned to one of the two control and intervention groups. The computerization process is done by an epidemiologist and a statistician. Individuals will enter the assigned groups based on their entry sequence. For the drug under study placebo is made by the same pharmaceutical company. Participants in the study are blind to receive actual medication. People who measure variables during research are also blind about how people belong to the groups ( two way blinding), Blinding description: This study is a double blind field trial. Hydroxychloroquine and placebo are made by Tehran Darou pharmaceutical company in uniform packages with defined codes. Drug and placebo will be dispensed by a third party. The participants in the study are blind to receive actual medication. People who measure the variables and fill out the questionnaires during the research are also blind about how people belong to the groups (two way blinding). 2-3 COVID-19. Intervention 1: Intervention group:The intervention group will take 800 mg i.e four 200 mg tablets of hydroxychloroquine in two separate doses once; and then 400 mg weekly in a single dose for 7 weeks and will be followed-up for 10 weeks. Drug and placebo are made by Tehran Darou Pharmaceutical Company. Intervention 2: Control group: Control group will take four placebo tablets in two separate doses once and then two placebo tablets weekly in a single dose for 7 weeks. ّّّThey will be followed-up for 10 weeks. Drug and placebo are made by Tehran Darou Pharmaceutical Company. 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 I have not decided yet.
public Mahnaz Valizadeh
5th floor, No 60, Manzarnejad St. Shariati St.
Tehran Iran (Islamic Republic of) 1948813471 +98 21 2285 9098 valizadeh@iautmu.ac.ir Islamic Azad University scientific Mahnaz Valizadeh
5th floor, No 60, Manzarnejad St. Shariati St.
Tehran Iran (Islamic Republic of) 1948813471 +98 21 2285 9098 valizadeh@iautmu.ac.ir Islamic Azad University Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Healthcare workers and students of Islamic Azad University Tehran Medical Branch(IAUTMU) affiliated hospitals. Age 18-70 years No symptoms of COVID19 at the time of registration No history of COVID-19 diagnosis within the past 3 months from joining the study Desire to participate in the study and filling out the consent form 18 years 70 years Both Any of COVID-19 symptoms at registration: fever, chills, cough, dyspnea,runny nose, loss of smell, loss of taste, headache, sore throat, chest pain, abdominal pain, nausea, vomiting, diarrhea, malaise and musculoskeletal pain History of COVID-19 within the past 3 months Contraindications for hydroxychloroquine including allergy to hydroxychloroquine , G6PD, Long QT Syndrome, porphyria, retinopathy Pregnancy Sever kidney or liver disease HIV, AIDS Systemic lupus erythematosus, rheumatoid arthritis active cancer U07.1 COVID19, virus identified Prevention Prevention Intervention group:The intervention group will take 800 mg i.e four 200 mg tablets of hydroxychloroquine in two separate doses once; and then 400 mg weekly in a single dose for 7 weeks and will be followed-up for 10 weeks. Drug and placebo are made by Tehran Darou Pharmaceutical Company. Control group: Control group will take four placebo tablets in two separate doses once and then two placebo tablets weekly in a single dose for 7 weeks. ّّّThey will be followed-up for 10 weeks. Drug and placebo are made by Tehran Darou Pharmaceutical Company. Sever forms of COVID-19( sever dyspnea, chest pain, decreased level of consciousness based on CDC definition) needing admission to hospital. Timepoint: Weekly for 10 weeks or until the discharge from hospital whichever is longer. Method of measurement: Weekly phone calls to participants and filling out the questionnaire forms. Sever forms of COVID-19 Diseases needing admission to ICU due to respiratory failure. Timepoint: Weekly for 10 weeks or until the discharge from hospital whichever is longer. Method of measurement: Weekly phone calls to participants and filling out the questionnaire forms. Mortality. Timepoint: weekly for 10 weeks or until discharge from hospital whichever is longer. Method of measurement: Weekly phone calls to participants and filling out the questionnaire forms. Mild types of COVID-19 with at least one of the symptoms of fever, cough, dyspnea, myalgia, loss of smell or taste, flu like symptoms with either polymerase-chain-reaction (PCR) confirmed COVID-19 or Positive CT scan suggestive of COVID-19. Timepoint: Weekly for 10 weeks. Method of measurement: Weekly phone calls to participants and filling out the questionnaire forms. Drug side effect. Timepoint: weekly for 7 weeks. Method of measurement: Weekly phone calls and filling out the questionnaire forms. Islamic Azad University Approved 2020-04-12 Ethics committee of Islamic Azad University Tehran Medical Sciences, Faculty of pharmacy No. 16, West Gholeyakh, Ayeneh Boulevard, Pabarja St. Shariati St. Tehran Tehran Iran (Islamic Republic of)