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IRCT20200415047092N1 IRCT 2020-04-20 Tehran University of Medical Sciences The effect of azithromycin in treatment of COVID19 Safety and Effectiveness of azithromycin in Patients with COVID-19 Referred to zeiaeian Hospital : A clinical trial study 2020-04-24 anticipated 110 Complete https://irct.ir/trial/47244 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients use randomized block-chain, which not only makes Randomization equal in two groups, but also allows patients to be assigned equally to both groups at each stage of the study. These small blocks keep the balance between the two groups and make the number of people in each group similar. In our study, considering that there are two groups, four patients are considered for each block. 3 SARS-COV2 ASSOCIATED INFECTION. Intervention 1: Intervention group: These patients receive daily azithromycin 500 mg, bi-daily oseltamivir 75, bi-daily lopinavir/ritonavir or in case of adverse gastrointestinal effects daily atazanavir (Kaletra) 400/100 mg and daily 400 mg of hydroxychloroquine; all for 5 days. Intervention 2: Control group: These patients receive bi-daily oseltamivir 75, bi-daily lopinavir/ritonavir or atazanavir (Kaletra) 400/100 mg and in case of adverse gasterointestinal effects, daily atazanavir (Kaletra) 400/100 mg and daily 400 mg of hydroxychloroquine; all drugs are administered for five days. Yes - There is a plan to make this available What will be shared: A part of the data, such as information about the main consequence or similar, can be shared. When: Start of access from 1399 To whom: Researchers working in academic and scientific institutions, people who are also engaged in industry Conditions: Mentioning the source and Permission and consultation with the responsible author are mandatory Where to obtain: EMAIL DR.FERESHTEGHIASVAND How to obtain: Send emails and mention the required files and the reason for the request and description of using the data Comments:
public Ehsan Sekhavati Moghadam
Zeiaeian hospital , Abuzar Ave
Tehran Iran (Islamic Republic of) 1366736511 +98 21 5517 6810 Dr.esekhavati@gmail.com Tehran University of Medical Sciences scientific Fereshte Ghiasvand
Imam Khomeyni hospital , Dr Gharib Ave
Tehran Iran (Islamic Republic of) 1419733141 02161190 Ghiasvand_62@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) - Obtaining informed consent from patient or patient’s legal proxy for inclusion in this study.- Patients must be over 18 years of age- A documented positive PCR test for SARS-CoV-2 or one of the following criteria:1. Compelling clinical symptoms associated with a covid-19 infection; including: fever, dry cough and dyspnea2. A typically involvement of lungs observed in HRCT or Spiral CT scanning that can be strongly attributed to a covid-19 pneumonia3. Patients that have developed known complications of a covid-19 infection such as acute respiratory distress syndrome (ARDS) or myocarditis. 18 years no limit Both pregnancy or nursing Patients whose covid-10 infection has not been proven and have symptoms that can be attributed to either the common cold or influenza and/or have had a positive PCR test for influenza. known allergy to chloroquine or hydroxylchloroquine retinopathy G6PD deficiency prolonged QT interval severe heart failure Pacemaker implantation cardiac arrhythmia U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: These patients receive daily azithromycin 500 mg, bi-daily oseltamivir 75, bi-daily lopinavir/ritonavir or in case of adverse gastrointestinal effects daily atazanavir (Kaletra) 400/100 mg and daily 400 mg of hydroxychloroquine; all for 5 days. Control group: These patients receive bi-daily oseltamivir 75, bi-daily lopinavir/ritonavir or atazanavir (Kaletra) 400/100 mg and in case of adverse gasterointestinal effects, daily atazanavir (Kaletra) 400/100 mg and daily 400 mg of hydroxychloroquine; all drugs are administered for five days. Peripheral capillary oxygen saturation. Timepoint: At the beginning of the visit and daily during admission. Method of measurement: pulse oximeter. Admission duration. Timepoint: From the beginning of the hospital visit to the discharge. Method of measurement: Questionnaire. Fever. Timepoint: At the beginning of the visit and daily during admission. Method of measurement: Mercury thermometer. Need to ICU admission. Timepoint: During admission. Method of measurement: Questionnaire. Tehran University of Medical Sciences Approved 2020-04-08 Ethics committee of Tehran University of Medical Sciences zeiaeian hospital, abuzar ave. tehran Tehran Iran (Islamic Republic of)