Cyclosporine A in hospitalized COVID-19 pneumonia patients to prevent the development of interstitial lung disease: a pilot randomized clinical trial

Autor: 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
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Scientific Reports, Vol 14, Iss 1, Pp 1-11 (2024)
Druh dokumentu: article
ISSN: 2045-2322
DOI: 10.1038/s41598-024-54196-5
Popis: 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).
Databáze: Directory of Open Access Journals
Nepřihlášeným uživatelům se plný text nezobrazuje