Cyclosporine A in hospitalized COVID-19 pneumonia patients to prevent the development of interstitial lung disease: a pilot randomized clinical trial.
- Resource Type
- Academic Journal
- Authors
- Cobo-Ibáñez T; Department of Rheumatology, Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, 28702, Madrid, Spain. mtcoboiba@yahoo.es.; Fundación para la Investigación e Innovación Biomédica del Hospital Universitario Infanta Sofía y Hospital Universitario del Henares (FIIB HUIS HHEN), 28702, Madrid, Spain. mtcoboiba@yahoo.es.; Mora Ortega G; Department of Pneumology, Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, 28702, Madrid, Spain.; Sánchez-Piedra C; Instituto de Salud Carlos III, 28029, Madrid, Spain.; Serralta-San Martín G; Department of Internal Medicine, Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, 28702, Madrid, Spain.; Thuissard-Vasallo IJ; Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, 28670, Madrid, Spain.; Lores Gutiérrez V; Department of Pneumology, Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, 28702, Madrid, Spain.; Soler Rangel L; Department of Internal Medicine, Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, 28702, Madrid, Spain.; García Yubero C; Deparment of Pharmacy, Hospital Universitario Infanta Sofía, 28702, Madrid, Spain.; Esteban-Vázquez A; Department of Rheumatology, Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, 28702, Madrid, Spain.; López-Aspiroz E; Deparment of Pharmacy, Hospital Universitario Infanta Sofía, 28702, Madrid, Spain.; Andreu Vázquez C; Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, 28670, Madrid, Spain.; Toboso I; Deparment of Immunology, Hospital Universitario Infanta Sofía, 28702, Madrid, Spain.; Martínez Alonso de Armiño BM; Department of Emergency, Hospital Universitario Infanta Sofía, 28702, Madrid, Spain.; Olivares Alviso RA; Department of Emergency, Hospital Universitario Infanta Sofía, 28702, Madrid, Spain.; Calderón Nieto R; Department of Emergency, Hospital Universitario Infanta Sofía, 28702, Madrid, Spain.; Yañez C; Department of Emergency, Hospital Universitario Infanta Sofía, 28702, Madrid, Spain.; Zakhour González MA; Department of Emergency, Hospital Universitario Infanta Sofía, 28702, Madrid, Spain.; Sainz Sánchez T; Department of Pneumology, Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, 28702, Madrid, Spain.; Arroyo de la Torre S; Department of Pneumology, Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, 28702, Madrid, Spain.; Del Amo Del Arco N; Central Laboratory, Hospital Universitario Infanta Sofía, 28702, Madrid, Spain.; Gómez-Cerezo JF; Department of Internal Medicine, Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, 28702, Madrid, Spain.; Ramírez Prieto T; Department of Pneumology, Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, 28702, Madrid, Spain.; Martínez Hernández A; Deparment of Pharmacy, Hospital Universitario Infanta Sofía, 28702, Madrid, Spain.; Muñoz-Fernández S; Department of Rheumatology, Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, 28702, Madrid, Spain.
- Source
- Publisher: Nature Publishing Group Country of Publication: England NLM ID: 101563288 Publication Model: Electronic Cited Medium: Internet ISSN: 2045-2322 (Electronic) Linking ISSN: 20452322 NLM ISO Abbreviation: Sci Rep Subsets: MEDLINE
- Subject
- Language
- English
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).
(© 2024. The Author(s).)