Nintedanib for the Treatment of SARS-Cov-2 Induced Pulmonary Fibrosis

Exclusion Criteria

• •Pre-existing lung disorder with abnormal HRCT (including COPD, lung cancer, or pulmonary fibrosis)
• •Laboratory parameter thresholds:
• •renal insufficiency with following criteria: Creatinine clearance \<30 ml/min estimated by the Cockcroft-Gault equation.
• •any of the following liver test criteria above the specified limit: Total bilirubin \> 1.5 above the upper limit of the normal range (ULN), except in patients with predominantly unconjugated hyperbilirubinemia (e.g., Gilbert's syndrome). Aspartate or alanine aminotransferase (AST or ALT) \>3 × ULN (refer to the protocol, Table 3 p 34 for the management of liver enzyme elevation).
• •Recent surgery with wound healing in progress(\<7days )
• •Patients with underlying chronic liver disease (Child Pugh A, B or C hepatic impairment).
• •Significant pulmonary arterial hypertension (PAH) defined by any of the following:
• •1. Previous clinical or echocardiographic evidence of significant right heart failure
• •2. History of right heart catheterisation showing a cardiac index ≤2 L/min/m²
• •3. PAH requiring parenteral therapy with epoprostenol/treprostinil.
• •History of cardiovascular diseases, any of the following:
• •1. Severe hypertension, uncontrolled under treatment (≥160/100 mmHg), within 6 months of Visit 1
• •2. Myocardial infarction within 6 months of Visit 1
• •3. Unstable cardiac angina within 6 months of Visit 1.
• •Bleeding risk, any of the following:
• •1. Known genetic predisposition to bleeding.
• •2. Patients who require
• •i. Fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, direct thrombin inhibitors, heparin, hirudin) ii. High dose antiplatelet therapy.
• •Alcohol or drug abuse which in the opinion of the treating physician would interfere with treatment.
• •Ongoing or past antifibrotic treatment with pirfenidone or nintedanib
• •Hypersensitivity to nintedanib, peanut or soya or to any of the excipients of the specialty Ofev®
• •Patients not able to understand and follow study procedures including completion of self-administered questionnaires without help.
• •No written informed consent from the patient
• •Absence of affiliation to the French social security
• •Participation in another interventional research