Evaluation of the efficacy of Silymarin in patients with COVID-19
Phase 3
Recruiting
- Conditions
- Patients with COVID-2019.COVID-19U07.01
- Registration Number
- IRCT20201024049130N1
- Lead Sponsor
- Artesh University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Patients with clinical or laboratory diagnosis of covid-19 should be hospitalized based on the opinion of a specialist physician.
age between 18 to 75
Signing an informed consent form
Exclusion Criteria
Pregnancy and lactation
Active liver disease
Severe renal failure GFR <30 ml/min
Inability of the patient to swallow oral medication
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to clinical improvement. Timepoint: 28 days from study enrollment. Method of measurement: Instrument name: Ordinal Scale for Clinical Improvement. The Sequential Clinical Recovery Scale is used by the World Health Organization for Covid patients. This scale contains 8 scores. the scores include: 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen by mask or nasal prongs 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation 7. Hospitalized, on invasive mechanical ventilation + additional organ support (pressors, RRT, ECMO) 8. Death.
- Secondary Outcome Measures
Name Time Method Mortality. Timepoint: 28 days from study enrollment. Method of measurement: All cause mortality (ACM).;Length of Hospitalization. Timepoint: Hospitalization time at the discretion of the physician. Method of measurement: days.