This is open-labe randomized multicenter comparative Phase III study conducted in 5 medical facilities. The objective of the study is to assess the efficacy and safety of Favipiravir compared with the Standard of care (SOC) in hospitalized patients with moderate COVID-19 pneumonia.
Upon signing the informed consent form and screening, 200 eligible patients with polymerase chain reaction (PCR) confirmed COVID-19 are randomized at a 1:1 ratio to receive either Favipiravir 1600 mg twice a day (BID) on Day 1 followed by 600 mg BID on Days 2-14 (1600/600 mg), or SOC. The course of treatment by Favipiravir is 14 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
200 mg coated tablets
Drug: Standard of Care Standard of Care will be prescribed in accordance with the recommended treatment regimens presented in the Russian guidelines for the prevention, diagnosis and treatment of COVID-19 according to the decision of the Investigator. Other Name: Hydroxychloroquine, chloroquine, lopinavir/ritonavir, etc.
State Clinical Hospital №50
Moscow, Russia
Regional Clinic Hospital of Ryazan
Ryazan, Russia
City Hospital N40 of Kurortny District
Saint Petersburg, Russia
Medical institute Ogarev Mordovia State university
Saransk, Russia
Rate of Clinical Status Improvement
Rate of clinical status improvement by 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 Viral Elimination by Day 10
Percentage of patients with elimination (clearance) of COVID-19 according to PCR data by day 10 (negative PCR results).
Time frame: 10 days
Time Before the End of Fever
Time (in days) before the end of fever (body temperature \< 37.2 ° C for 3 consecutive days without antipyretic medication).
Time frame: 28 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)
Time frame: Days 15, 21, 28
Rate of Transfer to the Intensive Care Unit
Percentage of patients transferred to intensive care unit (% of patients).
Time frame: 28 Days
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Smolensk clinical hospital №1
Smolensk, Russia
Rate of the Use of Non-invasive Lung Ventilation
Percentage of cases with non-invasive lung ventilation (% of patients).
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