COVID-19 Pneumonia
Conditions
Brief summary
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.
Interventions
Pirfenidone 200mg tid for first week; subsequently, 400mg tid for 2 months
DRUGPirfenidone placebo
Pirfenidone placebo
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects Age ≥ 18 Willing and able to provide written informed consent * SARS-CoV-2 infection confirmed by PCR test/antigen dectection or positive serologies * Time of illness onset ≥8 days * Have findings consistent with interstitial lung disease found on CT scan * Willing not use other investigational agents of anti-fibrosis
Exclusion criteria
* Pre-existing severe liver disease * Pre-existing severe chronic kidney disease * Pre-existing interstitial lung disease * Pre-existing severe COPD or other structural lung disease * Receiving invasive mechanical ventilation * Currently Pregnant or Breast Feeding * Poor baseline health conditoin * Disability to complete lung function test * Receiving pirfenidone wthin half-year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To investigate the effect of pirfenidone on fibrotic signs induced by COVID19 infection | 1 month | 1. Change of total lung lesion volume on Chest CT from enrollment to 1 month follow up 2. DLCO% pred at 1 month follow up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the EuroQol five-dimension five-level (EQ-5D-5L) | at the 1 month and 3 months follow-up vist | the difference between intervention group and placebo group |
| Medical Research Council (mMRC) dyspnoea scale | at the 1 month and 3 months follow-up vist | the difference of mMRC score between intervention group and placebo group |
| difference of forced vital capacity (FVC) between two groups | at the 1 month and 3 months follow-up vist | the difference of actual and predicted value between intervention group and placebo group |
| distance walked in 6 Minutes (6MWD) | at the 1 month and 3 months follow-up vist | the difference between intervention group and placebo group |
| difference of DLCO between two groups | at the 3 months follow-up vist | the difference of actual and predicted value between intervention group and placebo group |
| incidence of adverse event | within 2 months after enrollment | the difference of adverse event frequency between intervention group and placebo group |
| difference of total lung capacity (TLC) between two groups | at the 1 month and 3 months follow-up vist | the difference of actual and predicted value between intervention group and placebo group |
Countries
China
Outcome results
None listed