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

Who is this study for? Patients with SARS-Cov-2 Induced Pulmonary Fibrosis
What treatments are being studied? Nintedanib
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: f
View:

• History of hospitalization for COVID-19 infection documented with positive PCR or positive serology in the previous 2 to 12 months

• Lung opacities on HRCT involving more than 10% of the lung volume, with fibrotic features

• DLCO≤ 70% of the predicted value

Locations
Other Locations
France
Pneumologie
RECRUITING
Paris
Contact Information
Primary
Bruno Crestani, MD,PHD
bruno.crestani@aphp.fr
01 40 25 68 00
Time Frame
Start Date: 2020-10-29
Estimated Completion Date: 2024-07
Participants
Target number of participants: 250
Treatments
Experimental: Nintedanib
Experimental group will receive nintedanib 150mg BID for 12 months in addition to standard of care (SoC). Nintedanib dose could be reduced to 100mg BID depending on tolerance according to investigator in charge of the patient. The prescription of SoC drugs or procedure will be let to the choice of the investigator in charge of the patient.
Placebo_comparator: Placebo
Control group will receive Placebo BID for 12 months in addition to SoC. The prescription of SoC drugs or procedure will be let to the choice of the investigator in charge of the patient. Standard of care may include pulmonary rehabilitation.
Related Therapeutic Areas
Sponsors
Collaborators: Boehringer Ingelheim
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov