Cyclosporin A as an Add-On Therapy to a Corticosteroid-Based Background Treatment in Patients with COVID-19: A Multicenter, Randomized Clinical Trial.

Autor: Llanos Jiménez L; Fundación Jiménez Díaz (FJD) University Hospital, FJD Health Research Institute, Universidad Autónoma de Madrid (IIS-FJD, UAM), 28040 Madrid, Spain., Alvarez-Alvarez B; Fundación Jiménez Díaz (FJD) University Hospital, FJD Health Research Institute, Universidad Autónoma de Madrid (IIS-FJD, UAM), 28040 Madrid, Spain., Fonseca Aizpuru E; Cabueñes Hospital, 33394 Asturias, Spain., Peces-Barba G; Fundación Jiménez Díaz (FJD) University Hospital, FJD Health Research Institute, Universidad Autónoma de Madrid (IIS-FJD, UAM), 28040 Madrid, Spain., Pindao Quesada G; Villalba General University Hospital, FJD Health Research Institute, Universidad Autónoma de Madrid (IIS-FJD, UAM), 28400 Madrid, Spain., Rodríguez Nieto MJ; Fundación Jiménez Díaz (FJD) University Hospital, FJD Health Research Institute, Universidad Autónoma de Madrid (IIS-FJD, UAM), 28040 Madrid, Spain.; Villalba General University Hospital, FJD Health Research Institute, Universidad Autónoma de Madrid (IIS-FJD, UAM), 28400 Madrid, Spain., Ruiz-Hornillos FJ; Infanta Elena University Hospital, FJD Health Research Institute, Universidad Autónoma de Madrid (IIS-FJD, UAM), 28342 Madrid, Spain.; Faculty of Medicine, Universidad Francisco de Vitoria, 28223 Madrid, Spain., Seijo Maceiras L; Clínica Universitaria de Navarra (CUN), 28027 Madrid, Spain., Robles Barrena I; Rey Juan Carlos University Hospital (HURJC), FJD Health Research Institute, Universidad Autónoma de Madrid (IIS-FJD, UAM), 28933 Madrid, Spain., Mena-de-Cea A; Internal Medicine Department, A Coruña University Hospital Complex, 15006 A Coruña, Spain., Meijide-Míguez H; Quironsalud Hospital A Coruña, 15009 A Coruña, Spain., Sánchez-Pernaute O; Fundación Jiménez Díaz (FJD) University Hospital, FJD Health Research Institute, Universidad Autónoma de Madrid (IIS-FJD, UAM), 28040 Madrid, Spain.
Jazyk: angličtina
Zdroj: Journal of clinical medicine [J Clin Med] 2024 Sep 04; Vol. 13 (17). Date of Electronic Publication: 2024 Sep 04.
DOI: 10.3390/jcm13175242
Abstrakt: Background : In susceptible hosts, SARS-CoV2-induced hyperinflammation accounts for an increased mortality. The search of adjuvant immunomodulatory therapies has been ongoing ever since the pandemic outbreak. Aim: Our purpose was to evaluate the efficacy of cyclosporin A (CsA) as an add-on therapy to the standard of care (SoC) in patients with severe COVID-19 pneumonia. Methods : We conducted a randomized clinical trial in patients admitted to eight Spanish tertiary hospitals. Patients were stratified into two severity categories and randomized in a 1:1 ratio to receive a corticosteroid-based standard therapy with or without CsA. The primary endpoint was FiO2 recovery by Day 12 without relapses. Results : 109 patients were included and randomized, and 98 of them considered for the mITT population (51 assigned to the CsA + SoC group and 47 to the SoC group). A total of 35 (68.6%) patients from the CsA + SoC group and 32 (71.1%) patients from the SoC group reached the primary endpoint in the mITT analysis. No differences were found after stratification into age groups, in the severity level at admission, or in a combination of both. Overall, the time to FiO2 normalization was 7.4 days vs. 7.9 days in the experimental and control groups, respectively. Global mortality was 8.2%. Severe adverse events were uncommon and equally distributed between arms. Conclusion : The addition of CsA did not show differences over a corticosteroid-based treatment in the clinical course of the included patients. A better identification of candidates who will benefit from receiving immunomodulatory drugs is necessary in future studies.
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje