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).

Details

Title
Cyclosporine A in hospitalized COVID-19 pneumonia patients to prevent the development of interstitial lung disease: a pilot randomized clinical trial
Author
Cobo-Ibáñez, Tatiana 1 ; Mora Ortega, Gemma 2 ; Sánchez-Piedra, Carlos 3 ; Serralta-San Martín, Gonzalo 4 ; Thuissard-Vasallo, Israel J. 5 ; Lores Gutiérrez, Vanesa 6 ; Soler Rangel, Llanos 7 ; García Yubero, Cristina 8 ; Esteban-Vázquez, Ana 9 ; López-Aspiroz, Elena 8 ; Andreu Vázquez, Cristina 5 ; Toboso, Inmaculada 10 ; Martínez Alonso de Armiño, Blanca María 11 ; Olivares Alviso, Rocío Alejandra 11 ; Calderón Nieto, Rocío 11 ; Yañez, Cecilia 11 ; Zakhour González, Marlín Alejandra 11 ; Sainz Sánchez, Tatiana 12 ; Arroyo de la Torre, Silvia 12 ; Del Amo Del Arco, Nazaret 13 ; Gómez-Cerezo, Jorge Francisco 14 ; Ramírez Prieto, Teresa 12 ; Martínez Hernández, Alicia 8 ; Muñoz-Fernández, Santiago 9 

 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) 
 Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, Department of Pneumology, Madrid, Spain (GRID:grid.459562.9) 
 Instituto de Salud Carlos III, Madrid, Spain (GRID:grid.413448.e) (ISNI:0000 0000 9314 1427) 
 Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, Department of Internal Medicine, Madrid, Spain (GRID:grid.413448.e) 
 Universidad Europea de Madrid, Department of Medicine, Faculty of Biomedical and Health Sciences, Madrid, Spain (GRID:grid.119375.8) (ISNI:0000 0001 2173 8416) 
 Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, Department of Pneumology, Madrid, Spain (GRID:grid.119375.8) 
 Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, Department of Internal Medicine, Madrid, Spain (GRID:grid.119375.8) 
 Hospital Universitario Infanta Sofía, Deparment of Pharmacy, Madrid, Spain (GRID:grid.414758.b) (ISNI:0000 0004 1759 6533) 
 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) 
Pages
3789
Publication year
2024
Publication date
2024
Publisher
Nature Publishing Group
e-ISSN
20452322
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2927020746
Copyright
© The Author(s) 2024. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.