This is open-labe randomized multicenter comparative Phase III study conducted in 7 medical facilities. The objective of the study is to assess the efficacy and safety of Favipiravir for parenteral administration compared with the Standard of care (SOC) in hospitalized patients with moderate COVID-19 pneumonia.
Upon signing the informed consent form and screening, 217 eligible patients hospitalized with COVID-19 pneumonia were randomized at a 1:1 ratio to receive either Favipiravir intravenously by drip infusion for 2 hours 1600 mg twice a day (BID) on Day 1 followed by 800 mg BID on Days 2-14 (1600/800 mg), or SOC. The course of treatment by Favipiravir is 10 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
217
400 mg, lyophilizate for preparation of concentrate for solution for infusion
200 mg coated tablets
100 mg, lyophilizate for preparation of concentrate for solution for infusion
Regional budgetary health care institution "Ivanovo Clinical Hospital named after Kuvaevs"
Ivanovo, Russia
State Budgetary Institution of Healthcare of the City of Moscow "City Clinical Hospital No. 24 of the Department of Healthcare of the City of Moscow"
Moscow, Russia
State Clinical Hospital №50
Moscow, Russia
Regional Clinic Hospital of Ryazan
Ryazan, Russia
Rate of Clinical Status Improvement
Rate of clinical status improvement by WHO categorical ordinal scale of clinical status improvement by 2 or more categories by Day 10. WHO Ordinal Scale for Clinical Improvement (WHO-OSCI), 0 - uninfected (There are no clinical and virological signs of infection), 8 - dead, higher scores mean a worse outcome
Time frame: By Visit 3, approximately 10 days
Time to Clinical Improvement
Time (in days) to improvement in clinical status by WHO categorical ordinal scale of clinical status improvement
Time frame: 28 days
Rate of Clinical Status Improvement
Rate of clinical status improvement by WHO categorical ordinal scale of clinical status improvement by 2 or more categories at Visits 2 (Day 5) and 4 (Day 14)
Time frame: 14 days
Rate of Clinical Status Improvement
Percentage of patients with clinical status of 0 and 1 point according to the WHO categorical ordinal scale of clinical improvement on Days 5, 10 and 14.
Time frame: 14 Days
End of Fever on Days of study
Percentage of patients with fever disappearance (body temperature \< 37,2 °C in 3 consecutive measurements without antipyretic medication) an Days 5, 10 and 14.
Time frame: 14 Days
Change in the Level of Lung Damage According to CT
Assessment of lung injury (degree of damage by "empirical" visual scale and % of patients) according to CT data comparing to baseline. The number of patients in whom by the end of therapy there was an improvement in the condition of the lungs (a decrease in the volume of the lesion according to CT)
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Medical institute Ogarev Mordovia State university
Saransk, Russia
Smolensk clinical hospital №1
Smolensk, Russia
Time frame: 14 Days
Rate of Viral Elimination
Percentage of patients with SARS-CoV-2 elimination (negative test for SARS-CoV-2 by NAA method) on Days 5, 10, and 14.
Time frame: 14 days
Rate of Transfer to the Intensive Care Unit
Percentage of patients transferred to intensive care unit
Time frame: 28 days
Rate of the Use of Non-invasive Lung Ventilation
Percentage of cases with non-invasive lung ventilation
Time frame: 28 Days
Rate of the Use of Mechanical Ventilation
Percentage of cases with mechanical lung ventilation (% of patients)
Time frame: 28 Days
Mortality
Incidence of fatal cases (% of patients)
Time frame: 28 Days