학술논문
Cyclosporine A in hospitalized COVID-19 pneumonia patients to prevent the development of interstitial lung disease: a pilot randomized clinical trial
Document Type
article
Author
Tatiana Cobo-Ibáñez; Gemma Mora Ortega; Carlos Sánchez-Piedra; Gonzalo Serralta-San Martín; Israel J. Thuissard-Vasallo; Vanesa Lores Gutiérrez; Llanos Soler Rangel; Cristina García Yubero; Ana Esteban-Vázquez; Elena López-Aspiroz; Cristina Andreu Vázquez; Inmaculada Toboso; Blanca María Martínez Alonso de Armiño; Rocío Alejandra Olivares Alviso; Rocío Calderón Nieto; Cecilia Yañez; Marlín Alejandra Zakhour González; Tatiana Sainz Sánchez; Silvia Arroyo de la Torre; Nazaret Del Amo Del Arco; Jorge Francisco Gómez-Cerezo; Teresa Ramírez Prieto; Alicia Martínez Hernández; Santiago Muñoz-Fernández
Source
Scientific Reports, Vol 14, Iss 1, Pp 1-11 (2024)
Subject
Language
English
ISSN
2045-2322
Abstract
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).