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Study aim:
Determination of the efficiency of hydroxychloroquine drug regimen in comparison with hydroxychloroquine + azithromycin in hospitalized patients with covid-19 in the intensive care unit
Design:
Clinical trial with control group, double-blind, randomized, phase 3 on 40 patients. Table of random numbers are used for randomization.
Settings and conduct:
The study is performed in the ICU of Shahid Modarres Hospital. Participants, clinical care providers and evaluators of final outcomes are blinded
Participants/Inclusion and exclusion criteria:
Inpatients with COVID-19 in ICU of Shahid Modarres Hospital
- Inclusion criteria:
Diagnosis of COVID-19 based on either ground glass appearance in chest CT scan or positive PCR test for COVID-19;
Requiring hospitalization on the basis of level of consciousness,blood pressure, kidney and liver failure؛
age between 16 and 100 years؛
Signed informed consent form;
-Exclusion criteria:
Chronic liver or renal failure;
HIV;
Pregnancy& Breast feeding;
QT interval > 500 ms.
Intervention groups:
Dosage of the drug in the intervention group: 400 mg of hydroxychloroquine BD on the first day, and 200 mg 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 .
Dosage of the drug in the control group: hydroxychloroquine drug 400 mg BD on the first day and 200 mg hydroxychloroquine BD daily on the second to seventh day. Increase the duration of treatment to 10 days according to the doctor's order. The control group will receive placebo instead of Azithromycin.
Main outcome variables:
Duration of hospital stay in the intensive care unit, death in hospital, response to treatment based on radiological (CT scan) and laboratory criteria, fever, shortness of breath, Oxygen saturation without supplemental oxygen for 5 minutes, drug side effects