IRCT20200318046812N1
Completed
Phase 3
Evaluation of safety and efficacy of hydroxychloroquine plus favipiravir drug regimen in comparison with hydroxychloroquine plus kaletra on the need for intensive care unit treatment in patients with COVID-19; a randomized, multicenter, parallel groups, open label study
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Iran University of Medical Sciences
- Enrollment
- 324
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 because of: Patient's oxygen saturation less than 93% OR
- •Requiring hospitalization because of: GCS score less than 15 OR
- •Requiring hospitalization because of: systolic blood pressure less than 100 or 30 mmHg decrease in systolic blood pressure from the level prior to current illness OR
- •Requiring hospitalization because of: renal failure (creatinine 1\.5 times the previous measurement in the last 7 days OR
- •Requiring hospitalization because of: liver failure (AST and ALT 3 times upper limit of normal)
- •Patient's age between 16 and 100 years
- •Signed informed consent form.
Exclusion Criteria
- •Receiving other antiviral medications such as (Kaletra, Ribavirin, Oseltamivir, ...)
- •Chronic liver failure
- •Chronic Renal Failure
- •Patients with acute problems whose survival is expected to be less than 48 hours
- •HIV patients
- •A history of gastrointestinal bleeding
- •Pregnancy and lactation
- •QT interval exceeds 500 ms
Outcomes
Primary Outcomes
Not specified
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