The Bellvitge University Hospital and the Bellvitge Biomedical Research Institute (IDIBELL) are leading Fibro-Covid, a phase II clinical trial that will evaluate the therapeutic ability of pirfenidone to treat patients whose have initial clinical-radiological signs of pulmonary fibrosis, after having overcome severe pneumonia caused by Covid-19. This is the first clinical trial launched in the state to evaluate antifibrotic treatment for pulmonary sequelae of coronavirus.
A percentage of adults who have suffered severe pneumonia, with cytokine storm syndrome (CSS) and adult respiratory distress (ARDS), show signs of pulmonary fibrosis after two months of the acute episode. This fact has already been reported in other previous coronavirus epidemics, such as SARS or MERS. Pulmonary fibrosis induced by an external agent or associated with ARDS can be stable or progress. However, the clinical consequences are variable, including worsening quality of life (choking when doing physical activities, disabling cough) or requiring oxygen therapy to make efforts. Once pulmonary fibrosis is established and progresses, the disease has no cure, and only a lung transplant can prevent death. Pulmonary fibrosis is the consequence of an abnormal repair of the lung after some aggression, which forms pulmonary scar tissue that does not work for oxygen exchange.
Pirfenidone is an antifibrotic drug that slows the progression of idiopathic pulmonary fibrosis (IPF), also reducing its mortality, and the progressive forms of other types of pulmonary fibrosis (RELIEF study). Now, the Fibro-Covid clinical trial will determine if its administration is also effective in preventing the establishment of progressive pulmonary fibrosis in patients who present secular radiological images, after overcoming the acute phase of severe Covid-19 pneumonia. As Dr María Molina, head of the Pulmonary Interstitial Functional Unit of the Pneumology Service at Bellvitge Hospital, underlines, “our objective with this multicenter clinical trial is to assess whether this treatment inhibits progression and development of fibrosis, that sometimes leaves the transplant as the only vital option”.
The trial has been designed by Pneumology researchers, with the support of Pharmacy, Radiodiagnosis, the Central Unit for Clinical Research of Clinical Trials (UICEC) and Biostatistics of IDIBELL, and it has the collaboration of Roche. It will last approximately 14 months. This June begins with the process of recruiting participants from all the centres involved: in Catalonia, the Bellvitge, Santa Creu and Sant Pau, del Mar, Clínic and Germans Trias i Pujol hospitals; and in Madrid, the Puerta de Hierro, La Princesa and the Ramón y Cajal. The possible positive effects of the active ingredient administration will be evaluated after 6 months of treatment.
As long as there is no effective vaccine or treatment for SARS-CoV2 infection, the number of people with potentially disabling lung sequelae is increasing worldwide. Therefore, it is essential to advance as soon as possible towards a therapeutic approach that manages to prevent its progression. “In Europe, we find an older population than in other continents, which makes them more prone to developing fibrosis in case of lung attacks or injuries. As occurs with skin wounds or bone fractures, with age we lose correct tissue repair capacity”, says Dr Molina, also a researcher at IDIBELL. He adds that “this pandemic is leaving many dead, but the number of survivors is greater. And after a severely acute phase, some of these cases in the older population are left with pulmonary sequelae that are difficult to recover spontaneously. Therefore, it is necessary to find a treatment that prevents progression to established or fatal pulmonary fibrosis in the medium-long term”, she concludes.
Text adapted from Bellvitge University Hospital