COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002114-40/FR

Assistance Publique - Hôpitaux de Paris - Project Manager

didier.bouton@aphp.fr

2020-06-17

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Long covid

Age > 18 years and <89 years - History of hospitalization for COVID-19 infection documented with positive PCR or positive serology in the previous 2 to 6 months - Lung opacities on HRCT involving more than 10% of the lung volume, with fibrotic features - DLCO≤ 70% predicted

- Pre-existing lung disorder with abnormal HRCT (including COPD, lung cancer, or pulmonary fibrosis) - Recent surgery with wound healing in progress - 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: a. Previous clinical or echocardiographic evidence of significant right heart failure b. History of right heart catheterisation showing a cardiac index ≤2 L/min/m² c. PAH requiring parenteral therapy with epoprostenol/treprostinil. - History of cardiovascular diseases, any of the following: a. Severe hypertension, uncontrolled under treatment (≥160/100 mmHg), within 6 months of Visit 1 b. Myocardial infarction within 6 months of Visit 1 c. Unstable cardiac angina within 6 months of Visit 1. - Bleeding risk, any of the following: a. Known genetic predisposition to bleeding. b. Patients who require i. Fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, direct thrombin inhibitors, heparin, hirudin) ii. High dose antiplatelet therapy. - Pregnancy or lactation (women of childbearing capacity are required to have a negative serum pregnancy test before treatment and must agree to maintain highly effective contraception by practicing abstinence or by using at least two methods of birth control from the date of consent to three months after the end of the patient study participation). - 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

2

Assistance Publique - Hôpitaux de Paris

18

88

France

Patients recovered from covid

N/A

250

annual rate of decline in FVC from inclusion to 12 months, assessed by spirometry in accordance with international guidelines. Annual rate of decline in FVC will be estimated by linear regression from FVC measurements at inclusion and at 3, 6, 9 and 12 months.

Duplicate NCT04541680 not in our database

Phase 3

[{"arm_notes": "", "treatment_id": 887, "treatment_name": "Nintedanib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]