Hydroxychloroquine in comparison with hydroxychloroquine + azithromycin in patients with covid-19

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2020
INTERVENTION: 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. CONDITION: COVID‐19 COVID‐19. ; U07.1 ‐ COVID‐19 PRIMARY OUTCOME: In‐hopital mortality. Timepoint: once. Method of measurement: Medical records. Length of stay in the intensive care unit. Timepoint: Once (when discharged from intensive care unit). Method of measurement: Hospital records. SECONDARY OUTCOME: Adverse drug reactions. Timepoint: Daily. Method of measurement: Adverse Drug Reaction forms. Dyspnea. Timepoint: Daily. Method of measurement: Patient medical records. Fever. Timepoint: Daily. Method of measurement: Patient medical records. Laboratory Treatment Response; return of blood cell count and CRP values to normal. Timepoint: Daily. Method of measurement: Laboratory kits. Length of stay in hospital. Timepoint: Once at discharge. 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. 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. INCLUSION CRITERIA: 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
Epistemonikos ID: 90f5c24ab06f7d221da082be78a07e8712da9bee
First added on: Jun 11, 2020