Actively Recruiting
Nintedanib for the Treatment of SARS-Cov-2 Induced Pulmonary Fibrosis
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-05-16
250
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
B
Boehringer Ingelheim
Collaborating Sponsor
AI-Summary
What this Trial Is About
Currently, there is no approved treatment for COVID-19 in France, either for the acute phase, nor for the late chronic phase. the investigator suggest that nintedanib has the potential to block the development of lung fibrosis when initiated early enough to inhibit the activation of mesenchymal cells and the progression of virus-induced pulmonary fibrosis. Computerized Tomography (CT) manifestations of fibrosis or fibrous stripes are described in COVID-19 (Ye, Eur Radiol 2020). Pan et al observed fibrous stripes in 17% patients in the early phase of the disease (Pan, Eur Radiol 2020). Ye et al observed bronchiectasis in 2 patients (15.4%) and evidence of pulmonary fibrosis in 3 patients (23.7%) at HRCT performed at 4 weeks (Ye, Eur Radiol 2020). Long term data are still lacking in patients with COVID-19 and the investigators do not know how many patients will have fibrotic sequelae from the acute illness.
CONDITIONS
Official Title
Nintedanib for the Treatment of SARS-Cov-2 Induced Pulmonary Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of hospitalization for COVID-19 infection confirmed by positive PCR or serology within the previous 2 to 12 months
- Lung opacities on high-resolution CT involving more than 10% of lung volume with fibrotic features
- Diffusing capacity of the lungs for carbon monoxide (DLCO) less than or equal to 70% of the predicted value
You will not qualify if you...
- Pre-existing lung disorders with abnormal high-resolution CT including COPD, lung cancer, or pulmonary fibrosis
- Renal insufficiency with creatinine clearance below 30 ml/min estimated by the Cockcroft-Gault equation
- Liver test abnormalities: total bilirubin above 1.5 times the upper limit of normal except in certain cases; AST or ALT over 3 times the upper limit of normal
- Recent surgery with wound healing in progress less than 7 days
- Chronic liver disease with Child Pugh A, B or C hepatic impairment
- Significant pulmonary arterial hypertension defined by right heart failure, low cardiac index, or need for parenteral therapy
- History of cardiovascular disease including severe uncontrolled hypertension, recent myocardial infarction, or unstable angina within 6 months
- Known bleeding risk or use of certain anticoagulant or high-dose antiplatelet therapies
- Alcohol or drug abuse interfering with treatment
- Ongoing or past antifibrotic treatment with pirfenidone or nintedanib
- Hypersensitivity to nintedanib, peanut, soya, or any excipients of Ofev
- Inability to understand or follow study procedures including self-questionnaires
- Lack of written informed consent
- Absence of affiliation to the French social security system
- Participation in another interventional research study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Pneumologie
Paris, France, 95018
Actively Recruiting
Research Team
B
Bruno Crestani, MD,PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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