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Abstract
Post-COVID-19 interstitial lung disease (ILD) is a new entity that frequently causes pulmonary fibrosis and can become chronic. We performed a single-center parallel-group open-label pilot randomized clinical trial to investigate the efficacy and safety of cyclosporine A (CsA) in the development of ILD in the medium term among patients hospitalized with COVID-19 pneumonia. Patients were randomized 1:1 to receive CsA plus standard of care or standard of care alone. The primary composite outcome was the percentage of patients without ILD 3 months after diagnosis of pneumonia and not requiring invasive mechanical ventilation (IMV) (response without requiring IMV). The key secondary composite outcomes were the percentage of patients who achieve a response requiring IMV or irrespective of the need for IMV, and adverse events. A total of 33 patients received at least one dose of CsA plus standard of care (n = 17) or standard of care alone (n = 16). No differences were found between the groups in the percentage of patients who achieved a response without requiring IMV or a response requiring IMV. A higher percentage of patients achieved a response irrespective of the need for IMV in the CsA plus standard of care group although the RR was almost significant 2.833 (95% CI, 0.908–8.840; p = 0.057). No differences were found between the groups for adverse events. In hospitalized patients with COVID-19 pneumonia, we were unable to demonstrate that CsA achieved a significant effect in preventing the development of ILD. (EU Clinical Trials Register; EudraCT Number: 2020-002123-11; registration date: 08/05/2020).
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1 Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, Department of Rheumatology, Madrid, Spain; Fundación para la Investigación e Innovación Biomédica del Hospital Universitario Infanta Sofía y Hospital Universitario del Henares (FIIB HUIS HHEN), Madrid, Spain (GRID:grid.459562.9) (ISNI:0000 0004 1759 6496)
2 Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, Department of Pneumology, Madrid, Spain (GRID:grid.459562.9)
3 Instituto de Salud Carlos III, Madrid, Spain (GRID:grid.413448.e) (ISNI:0000 0000 9314 1427)
4 Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, Department of Internal Medicine, Madrid, Spain (GRID:grid.413448.e)
5 Universidad Europea de Madrid, Department of Medicine, Faculty of Biomedical and Health Sciences, Madrid, Spain (GRID:grid.119375.8) (ISNI:0000 0001 2173 8416)
6 Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, Department of Pneumology, Madrid, Spain (GRID:grid.119375.8)
7 Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, Department of Internal Medicine, Madrid, Spain (GRID:grid.119375.8)
8 Hospital Universitario Infanta Sofía, Deparment of Pharmacy, Madrid, Spain (GRID:grid.414758.b) (ISNI:0000 0004 1759 6533)
9 Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, Department of Rheumatology, Madrid, Spain (GRID:grid.414758.b)
10 Hospital Universitario Infanta Sofía, Deparment of Immunology, Madrid, Spain (GRID:grid.414758.b) (ISNI:0000 0004 1759 6533)
11 Hospital Universitario Infanta Sofía, Department of Emergency, Madrid, Spain (GRID:grid.414758.b) (ISNI:0000 0004 1759 6533)
12 Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, Department of Pneumology, Madrid, Spain (GRID:grid.414758.b)
13 Hospital Universitario Infanta Sofía, Central Laboratory, Madrid, Spain (GRID:grid.414758.b) (ISNI:0000 0004 1759 6533)
14 Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, Department of Internal Medicine, Madrid, Spain (GRID:grid.414758.b)