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IRCT20200428047228N2 IRCT 2020-06-10 Quality Improvement of Intensive Care Research Center- Shahid Beheshti University Hydroxychloroquine in comparison with hydroxychloroquine + azithromycin in patients with covid-19 Evaluation of the efficiency of hydroxychloroquine drug regimen in comparison with hydroxychloroquine + azithromycin in hospitalized patients with covid-19 in the intensive care unit 2020-05-19 anticipated 40 Complete https://irct.ir/trial/48096 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization, Random Number Table The numbers will be assigned to the participants who have the inclusion criteria to enter the study, respectively, and according to the table of random numbers, the participants will be divided into two groups of intervention and control, Blinding description: Participants, health care personnel and evaluators of the final outcome are unaware of the drug and placebo given to the intervention and control group . 3 COVID-19. Intervention 1: Intervention group: hydroxychloroquine, 400 mg BD on the first day and 200 mg hydroxychloroquine BD daily on the second to seventh day and concurrent, Azithromycin at a dose of 500 mg on the first day and then 250 mg daily until the seventh day . The two groups will receive standard treatment. Intervention 2: Control group: hydroxychloroquine, 400 mg BD on the first day and 200 mg hydroxychloroquine BD daily on the second to seventh day. Increasing the duration of treatment to 10 days, according to the doctor's order. The control group will receive placebo instead of Azithromycin. 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) Diagnosis of COVID-19 based on either ground glass appearance in chest CT scan or positive RT-PCR test for COVID-19 Requiring hospitalization on the basis of level of consciousness,blood pressure, kidney and liver failure Patient's age between 16 and 100 years Signed informed consent form 16 years 100 years Both Chronic liver and kidney failure HIV patients pregnancy and breast feeding QT interval more than 500 milliseconds COVID-19 U07.1 - COVID-19 Treatment - Drugs Treatment - Drugs Intervention group: hydroxychloroquine, 400 mg BD on the first day and 200 mg hydroxychloroquine BD daily on the second to seventh day and concurrent, Azithromycin at a dose of 500 mg on the first day and then 250 mg daily until the seventh day . The two groups will receive standard treatment Control group: hydroxychloroquine, 400 mg BD on the first day and 200 mg hydroxychloroquine BD daily on the second to seventh day. Increasing the duration of treatment to 10 days, according to the doctor's order. The control group will receive placebo instead of Azithromycin Length of stay in the intensive care unit. Timepoint: Once (when discharged from intensive care unit). Method of measurement: Hospital records. In-hopital mortality. Timepoint: once. Method of measurement: Medical records. Length of stay in hospital. Timepoint: Once at discharge. Method of measurement: Patient medical records. Radiological Treatment Response (CT scan) , more than 50% reduction in the affected area. Timepoint: CT scan will be done twice (once at the time of admission and the second time 10 days after discharge). Assessment will be done comparing the second CT with the first one. Method of measurement: Patient CT scan. Laboratory Treatment Response; return of blood cell count and CRP values to normal. Timepoint: Daily. Method of measurement: Laboratory kits. Fever. Timepoint: Daily. Method of measurement: Patient medical records. Dyspnea. Timepoint: Daily. Method of measurement: Patient medical records. Oxygen saturation without supplemental oxygen. Measurement will be done after discontinuation of oxygen therapy for 5 minutes. Timepoint: 4 times a day while in the wards. Method of measurement: Observation. Adverse drug reactions. Timepoint: Daily. Method of measurement: Adverse Drug Reaction forms. Quality Improvement of Intensive Care Research Center- Shahid Beheshti University Approved 2020-05-03 Ethics committee of Shahid Beheshti University of Medical Sciences shahid Modarres Hospital, Saadat Abad, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)