An Adaptive, Multicenter, Randomized, Open-label, Comparative Clinical Study to Assess Efficacy and Safety of Favipiravir in Hospitalized Patients With COVID-19

The study is Phase II/III and consists of pilot and pivotal stages. The objective of the pilot stage is to conduct a preliminary assessment of the efficacy and safety of Favipiravir, and to select the optimal dosing regimen to study during the pivotal stage. The objective of the pivotal stage is to assess the efficacy and safety of Favipiravir compared with the Standard of care (SOC) in hospitalized patients with moderate to severe COVID-19 pneumonia.

开始日期2020-04-23

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Chromis Fiberoptics LLC

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2021-08-02·Clinical Infectious Diseases1区 · 医学

Reply to Krishna Prabha et al

1区 · 医学

Letter

作者: Ivachtchenko, Alexandre V ; Yakubova, Elena V ; Savchuk, Nikolay P ; Ivashchenko, Andrey A

2021-08-02·Clinical Infectious Diseases

AVIFAVIR for Treatment of Patients With Moderate Coronavirus Disease 2019 (COVID-19): Interim Results of a Phase II/III Multicenter Randomized Clinical Trial

Article

作者: Karapetian, Ruben N ; Pavlikova, Elena P ; Savchuk, Nikolay P ; Simakina, Elena N ; Papazova, Natalia A ; Smolyarchuk, Elena A ; Ivachtchenko, Alexandre V ; Egorova, Alina N ; Kravchenko, Dmitry V ; Dmitriev, Kirill A ; Yakubova, Elena V ; Gordeev, Ivan G ; Ilin, Alexey P ; Ivashchenko, Andrey A ; Tikhomolova, Elena G ; Vostokova, Natalia V ; Sitdekov, Tagir A ; Blinow, Andrew A ; Lomakin, Nikita V ; Merkulova, Elena A ; Azarova, Valeria N

AbstractIn May 2020 the Russian Ministry of Health granted fast-track marketing authorization to RNA polymerase inhibitor AVIFAVIR (favipiravir) for the treatment of COVID-19 patients. In the pilot stage of Phase II/III clinical trial, AVIFAVIR enabled SARS-CoV-2 viral clearance in 62.5% of patients within 4 days, and was safe and well-tolerated.Clinical Trials Registration. NCT04434248.

Aprotinin is a potent multi-target drug for the combination therapy of moderate COVID-19 cases

作者: Rosinkova, Olga ; Kravchenko, Dmitry ; Savchuk, Nikolay ; Simakina, Elena ; Topr, Mikhail ; Azarova, Valeria ; Krivonos, Natalia ; Merkulova, Elena ; Loginov, Vladimir ; Ivashchenko, Andrey ; Yakubova, Elena ; Ivachtchenko, Alexandre ; Karapetian, Ruben ; Poyarkov, Stanislav ; Egorova, Alina

Objectives. COVID-19 is a contagious multisystem inflammatory disease caused by a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We have studied the efficacy of Aprotinin (nonspeciﬁc serine proteases inhibitor) and Avifavir or Hydroxychloroquine (HCQ) combinations for the therapy of COVID-19. Methods. Three prospective single-center (cohorts 1 – 3) studies included participants with moderate COVID-19-related pneumonia, laboratory-confirmed SARS-CoV-2 and admitted to the hospitals. Patients received combinations of intravenous (IV) Aprotinin (1,000,000 KIU daily, 3 days) and HCQ (cohort 1), inhalation (inh) treatment with Aprotinin (625 KIU 4 times per day, 5 days) and HCQ (cohort 2) or IV Aprotinin (1,000,000 KIU daily for 5 days) and Avifavir (cohort 3). Results. In the cohorts 1 – 3, the combination therapy showed 100% efficacy in preventing the transfer of patients (n = 30) to the intensive care unit (ICU). The effect of combination therapy in the cohort 3 was the most prominent and the median time to SARS-CoV-2 elimination was 3.5 days (IQR 3.0 – 4.0), normalization of CRP concentration was 3.5 days (IQR 3 – 5), of D-dimer concentration - 5 days (IQR 4 – 5); body temperature - 1 day (IQR 1 – 3), improvement in clinical status or discharge from the hospital - 5 days (IQR 5 – 5), and improvement in lung lesions of patients on 14 day - 100%. Conclusions. The administration of Aprotinin combinations prevented the transfer of moderate COVID-19 patients to the ICU for mechanical ventilation (ALV) or non-invasive ventilation (NIV) and by shortening of their hospital stay.

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