The aim of the study is to assess the safety and efficacy of Favipiravir HU when administered to SARS-Cov- 2 patients in order to offer a safe and effective treatment to SARS-Cov-2 infection during the pandemic. The study is not for registration purposes and is not part of a series of studies for registration of Favipiravir HU.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1
Drug substance: Favipiravir Dose: 200 mg Administration: oral Formulation: capsules
Name: Placebo clinical sample Drug substance: placebo Dose: - Administration: oral Formulation: capsules
University of Szeged - Internal Medicine
Szeged, Hungary
PRIM1_ the percentage of virus copy number
The primary endpoint of the study is the percentage of virus copy number at Day6 compared to baseline.
Time frame: 5 months
SEC1_mortality rate
Overall mortality rate
Time frame: 6 months
SEC2_respiratory failure
Proportion of patients with respiratory failure
Time frame: 6 months
SEC3_ intensive care
Proportion of patients with need for intensive care
Time frame: 6 months
SEC4_non-invasive respiratory support
Proportion of patients with need for non-invasive respiratory support
Time frame: 6 months
SEC5_ invasive respiratory support
Proportion of patients with need for invasive respiratory support
Time frame: 6 months
SEC6_ Acute Respiratory Distress Syndrome
Proportion of patients with Acute Respiratory Distress Syndrome
Time frame: 6 months
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