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IRCT20200428047228N1 IRCT 2020-05-16 Quality Improvement of Intensive Care Research Center- Shahid Beheshti University Evaluation of the efficiency and safety of favipiravir + hydroxychloroquine drug regimen in comparison with hydroxychloroquine in hospitalized patients with covid-19 Evaluation of the efficiency and safety of favipiravir + hydroxychloroquine drug regimen in comparison with hydroxychloroquine in hospitalized patients with covid-19 2020-05-19 anticipated 50 Complete https://irct.ir/trial/47559 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization, Random Number Table, Blinding description: Participants, health care personnel and evaluators of the final outcome are unaware of the drug given to the intervention and control group . 3 COVID-19. Intervention 1: Intervention group: On the first day, 1600 mg of Favipiravir BD, and on the second to fifth day, 600 mg of Favipiravir BD and concurrent hydroxychloroquine, 400 mg BD on the first day and 200 mg hydroxychloroquine BD daily on the second to fifth day. The two groups will receive standard treatment (oxygen and, if necessary, antibiotics). Intervention 2: Control group: hydroxychloroquine, 400 mg BD on the first day and 200 mg hydroxychloroquine BD daily on the second to fifth day. Increasing the duration of treatment to 10 days, according to the doctor's order. The control group will receive placebo instead of Favipiravir. Yes - There is a plan to make this available What will be shared: Data can be shared after deleting participants' names. When: The access period will be started six months after the publication of the article. To whom: The data will be available only for academic researchers. Conditions: Only meta-analysis in collaboration with the current study research team will be permitted. Where to obtain: Researchers can request data by emailing Dr.Mohammad Fathi(m.fathi@sbmu.ac.ir) How to obtain: Requested data will be sent by email after consideration and approval by the relevant authorities from Shahid beheshti university. Comments:
public Dr. Mohammad Fathi
Shahid Modarres Hospital, Saadat abad, Tehran, Iran
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2351 5366 m.fathi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Dr. Mohammad Fathi
Shahid Modarres Hospital, Saadat abad, Tehran, Iran
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2351 5366 m.fathi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) a- Respiratory Rate(RR)≥30 /min b- SpO2<93% on room air c- PaO2/FIO2<300 d- CT scan Involvement>50% e- Diagnosis confirmed by CPR or CT scan f- Age more than 18 years 18 years no limit Both a- G6PD Deficiency b- QT interval more than 450 milliseconds c- myasthenia gravis d- Pregnancy- Breast Feeding e- Severe Renal or Hepatic Failure COVID-19 U07.1 - COVID-19 Treatment - Drugs Treatment - Drugs Intervention group: On the first day, 1600 mg of Favipiravir BD, and on the second to fifth day, 600 mg of Favipiravir BD and concurrent hydroxychloroquine, 400 mg BD on the first day and 200 mg hydroxychloroquine BD daily on the second to fifth day. The two groups will receive standard treatment (oxygen and, if necessary, antibiotics). Control group: hydroxychloroquine, 400 mg BD on the first day and 200 mg hydroxychloroquine BD daily on the second to fifth day. Increasing the duration of treatment to 10 days, according to the doctor's order. The control group will receive placebo instead of Favipiravir. No fever for 3 days. Timepoint: Daily. Method of measurement: Medical Records. - SpO2>93%. Timepoint: daily. Method of measurement: Medical Records. CXR observation. Timepoint: After the end of the treatment period. Method of measurement: Observation. - All cause Mortality. Timepoint: once. Method of measurement: Medical Records. - Need to Mechanical ventilation. Timepoint: Daily. Method of measurement: Medical Records. Drug Adverse Effect. Timepoint: Daily. Method of measurement: Medical Records. Quality Improvement of Intensive Care Research Center- Shahid Beheshti University Approved 2020-04-20 •Ethics committee of Shahid Beheshti University of Medical Sciences shahid Modarres Hospital, Saadat Abad, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)