COVID-19 Clinical Trial
Official title:
Efficacy and Safety of Nintedanib Ethanesulfonate Soft Capsule in the Treatment of Pulmonary Fibrosis in Patients With Moderate to Severe COVID-9(COVID 19) : a Single-center, Randomized, Placebo-controlled Study
This center intends to conduct a single-center, randomized, placebo-controlled study to evaluate the effectiveness and safety of Nintedanib ethanesulfonate soft capsule in the treatment of pulmonary fibrosis in patients with moderate to severe COVID-19.
This center intends to conduct a single-center, randomized, placebo-controlled study to
evaluate the effectiveness and safety of Nintedanib ethanesulfonate soft capsule in the
treatment of pulmonary fibrosis in patients with moderate to severe COVID-19. The number of
cases is estimated based on the following:
This exploratory trial is expected to complete 80 case studies (randomly divided into control
group and test group each with 40 cases), and the expected drop-out rate is not more than
20%, so the total number of cases is 96. Placebo control group:
Empty capsules with the same appearance and ingredients as Nintedanib soft capsules: one
capsule at a time, twice a day, with an interval of about 12 hours each time. Continuous
medication for 8 weeks.
Nintedanib Nintedanib cloth sulfonate soft capsule treatment: According to the drug manual
recommendation, give Nintedanib cloth sulfonate soft capsule 150mg twice daily with an
interval of about 12 hours each time, with food. Continuous medication for 8 weeks.
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