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Pilot Study to Assess Efficacy and Safety of Treamid in the Rehabilitation of Patients After COVID-19 Pneumonia

Treamid · Фаза 2

ID реестра
NCT04527354
Фаза
Фаза 2
Статус
Завершено
Препарат / вмешательство
Treamid
Спонсор
PHARMENTERPRISES LLC
Начало
2020-09-01
Набор участников
60
Центры
8

Об исследовании

The innovative drug Treamid is planned for use in the rehabilitation of patients after COVID-19 pneumonia in a pilot, multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to assess the efficacy and safety of Treamid, tablets, 50 mg in patients with fibrotic changes in the lungs after COVID-19 pneumonia during a 28-day treatment. The primary objective of the study is to demonstrate the efficacy of Treamid tablet, 50 mg in change in forced vital capacity (FVC) and/or diffusing capacity of lung for carbon monoxide (DLCO) at Week 4. The secondary objective of the study is to evaluate the safety of Treamid tablet, 50 mg and pharmacokinetics (PK).

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Связанные материалы

Медицинская оговорка. Эта страница обобщает публичные данные исследования NCT04527354 только для информации. Это не медицинская рекомендация, не одобрение и не предложение участия. Проверяйте детали на ClinicalTrials.gov и у квалифицированного врача.