Hydroxychloroquine in comparison with hydroxychloroquine + azithromycin in patients with covid-19
Phase 3
Recruiting
- Conditions
- COVID-19.U07.1 - COVID-19COVID-19
- Registration Number
- IRCT20200428047228N2
- Lead Sponsor
- Quality Improvement of Intensive Care Research Center- Shahid Beheshti University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
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
Exclusion Criteria
Chronic liver and kidney failure
HIV patients
pregnancy and breast feeding
QT interval more than 500 milliseconds
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ength 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.
- Secondary Outcome Measures
Name Time Method ength 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.