В России пройдут исследования китайского препарата от коронавируса
Министерство здравоохранения выдало разрешение на проведение третьей фазы клинических исследований препарата «проксалутамид» — одного из потенциальных лекарственных средств для борьбы с коронавирусной инфекцией COVID-19. Информация об этом опубликована 30 мая в Государственном реестре лекарственных средств.
Проксалутамид (также известный как GT0918) — ингибитор андрогенового рецептора (AR), разработанный китайской компанией Kintor Pharmaceutical для возможного лечения рака груди и простаты. Исследования этого ЛС показали его эффективность в лечении пациентов с коронавирусом за счёт снижения вирусной нагрузки на организм и сокращения времени пребывания больного в стационаре. В настоящее время проксалутамид официально одобрен для лечения COVID-19 только в Парагвае.
Минздрав одобрил проведение III фазы рандомизированного двойного слепого плацебо-контролируемого исследования препарата у госпитализированных пациентов с COVID-19. Целью испытаний является оценка клинической эффективности ЛС, которая будет определена по времени до восстановления пациентов в сравнении с контрольной группой, а также оценка снижения смертности на фоне терапии проксалутамидом.
Исследования пройдут в медицинских учреждениях во многих городах России: Смоленске, Красноярске, Кировске, Уфе, Кемерове, а также в Москве и Санкт-Петербурге. Окончание клинических испытаний запланировано на ноябрь 2023 года.
Ранее Министерство здравоохранения продлило до 2023 года полномочия специальной комиссии, которая может выдавать разрешения на оборот не зарегистрированных в России ЛС, предназначенных для применения в чрезвычайных ситуациях, в первую очередь для борьбы с коронавирусом.
31 мая 2022
Фото: © bogdan.hoda / Фотобанк Фотодженика
Выпуск: №221, май 2022475 просмотров
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