tetano
Editor, Senior Moderator
Sci Rep
. 2024 Feb 15;14(1):3789.
doi: 10.1038/s41598-024-54196-5. Cyclosporine A in hospitalized COVID-19 pneumonia patients to prevent the development of interstitial lung disease: a pilot randomized clinical trial
Tatiana Cobo-Ibáñez[SUP] #[/SUP][SUP] 1 2 [/SUP], Gemma Mora Ortega[SUP] #[/SUP][SUP] 3 [/SUP], Carlos Sánchez-Piedra[SUP] 4 [/SUP], Gonzalo Serralta-San Martín[SUP] 5 [/SUP], Israel J Thuissard-Vasallo[SUP] 6 [/SUP], Vanesa Lores Gutiérrez[SUP] 3 [/SUP], Llanos Soler Rangel[SUP] 5 [/SUP], Cristina García Yubero[SUP] 7 [/SUP], Ana Esteban-Vázquez[SUP] 8 [/SUP], Elena López-Aspiroz[SUP] 7 [/SUP], Cristina Andreu Vázquez[SUP] 6 [/SUP], Inmaculada Toboso[SUP] 9 [/SUP], Blanca María Martínez Alonso de Armiño[SUP] 10 [/SUP], Rocío Alejandra Olivares Alviso[SUP] 10 [/SUP], Rocío Calderón Nieto[SUP] 10 [/SUP], Cecilia Yañez[SUP] 10 [/SUP], Marlín Alejandra Zakhour González[SUP] 10 [/SUP], Tatiana Sainz Sánchez[SUP] 3 [/SUP], Silvia Arroyo de la Torre[SUP] 3 [/SUP], Nazaret Del Amo Del Arco[SUP] 11 [/SUP], Jorge Francisco Gómez-Cerezo[SUP] 5 [/SUP], Teresa Ramírez Prieto[SUP] 3 [/SUP], Alicia Martínez Hernández[SUP] 7 [/SUP], Santiago Muñoz-Fernández[SUP] 8 [/SUP]
Affiliations
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 Feb 15;14(1):3789.
doi: 10.1038/s41598-024-54196-5. Cyclosporine A in hospitalized COVID-19 pneumonia patients to prevent the development of interstitial lung disease: a pilot randomized clinical trial
Tatiana Cobo-Ibáñez[SUP] #[/SUP][SUP] 1 2 [/SUP], Gemma Mora Ortega[SUP] #[/SUP][SUP] 3 [/SUP], Carlos Sánchez-Piedra[SUP] 4 [/SUP], Gonzalo Serralta-San Martín[SUP] 5 [/SUP], Israel J Thuissard-Vasallo[SUP] 6 [/SUP], Vanesa Lores Gutiérrez[SUP] 3 [/SUP], Llanos Soler Rangel[SUP] 5 [/SUP], Cristina García Yubero[SUP] 7 [/SUP], Ana Esteban-Vázquez[SUP] 8 [/SUP], Elena López-Aspiroz[SUP] 7 [/SUP], Cristina Andreu Vázquez[SUP] 6 [/SUP], Inmaculada Toboso[SUP] 9 [/SUP], Blanca María Martínez Alonso de Armiño[SUP] 10 [/SUP], Rocío Alejandra Olivares Alviso[SUP] 10 [/SUP], Rocío Calderón Nieto[SUP] 10 [/SUP], Cecilia Yañez[SUP] 10 [/SUP], Marlín Alejandra Zakhour González[SUP] 10 [/SUP], Tatiana Sainz Sánchez[SUP] 3 [/SUP], Silvia Arroyo de la Torre[SUP] 3 [/SUP], Nazaret Del Amo Del Arco[SUP] 11 [/SUP], Jorge Francisco Gómez-Cerezo[SUP] 5 [/SUP], Teresa Ramírez Prieto[SUP] 3 [/SUP], Alicia Martínez Hernández[SUP] 7 [/SUP], Santiago Muñoz-Fernández[SUP] 8 [/SUP]
Affiliations
- PMID: 38360855
- PMCID: PMC10869838
- DOI: 10.1038/s41598-024-54196-5
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).