Evaluation of the efficiency and safety of favipiravir + hydroxychloroquine drug regimen in comparison with hydroxychloroquine in hospitalized patients with covid-19
Phase 3
Recruiting
- Conditions
- COVID-19.U07.1 - COVID-19COVID-19
- Registration Number
- IRCT20200428047228N1
- 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
- 50
Inclusion Criteria
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
Exclusion Criteria
a-G6PD Deficiency
b-QT interval more than 450 milliseconds
c-myasthenia gravis
d-Pregnancy- Breast Feeding
e-Severe Renal or Hepatic Failure
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method o 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.
- Secondary Outcome Measures
Name Time Method -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.