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This center intends to conduct a multicenter, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pirfenidone | Experimental | Pirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months |
|
| Placebo | Placebo Comparator | Pirfenidone placebo 200mg tid for first week; subsequently, 400mg tid for 2 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pirfenidone Oral Product | Drug | Pirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the effect of pirfenidone on fibrotic signs induced by COVID19 infection |
| 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| distance walked in 6 Minutes (6MWD) | the difference between intervention group and placebo group | at the 1 month and 3 months follow-up vist |
| the EuroQol five-dimension five-level (EQ-5D-5L) | the difference between intervention group and placebo group |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | 100029 | China |
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| Pirfenidone placebo | Drug | Pirfenidone placebo |
|
| at the 1 month and 3 months follow-up vist |
| Medical Research Council (mMRC) dyspnoea scale | the difference of mMRC score between intervention group and placebo group | at the 1 month and 3 months follow-up vist |
| difference of forced vital capacity (FVC) between two groups | the difference of actual and predicted value between intervention group and placebo group | at the 1 month and 3 months follow-up vist |
| difference of total lung capacity (TLC) between two groups | the difference of actual and predicted value between intervention group and placebo group | at the 1 month and 3 months follow-up vist |
| difference of DLCO between two groups | the difference of actual and predicted value between intervention group and placebo group | at the 3 months follow-up vist |
| incidence of adverse event | the difference of adverse event frequency between intervention group and placebo group | within 2 months after enrollment |