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

被引:0
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作者
Llanos Jimenez, Lucia [1 ]
Alvarez-Alvarez, Beatriz [1 ]
Fonseca Aizpuru, Eva [2 ]
Peces-Barba, German [1 ]
Quesada, Gloria Pindao [3 ]
Nieto, Ma Jesus Rodriguez [1 ,3 ]
Ruiz-Hornillos, Francisco J. [4 ,5 ]
Maceiras, Luis Seijo [6 ]
Barrena, Ignacio Robles [7 ]
Mena-de-Cea, Alvaro [8 ]
Meijide-Miguez, Hector [9 ]
Sanchez-Pernaute, Olga [1 ]
机构
[1] Univ Autonoma Madrid, UAM, Univ Hosp, FJD Hlth Res Inst,Fdn Jimenez Diaz FJD,IIS,FJD, Madrid 28040, Spain
[2] Cabuenes Hosp, Asturias 33394, Spain
[3] Univ Autonoma Madrid, Villalba Gen Univ Hosp, FJD Hlth Res Inst, UAM,IIS,FJD, Madrid 28400, Spain
[4] Univ Autonoma Madrid, Infanta Elena Univ Hosp, FJD Hlth Res Inst, UAM,IIS,FJD, Madrid 28342, Spain
[5] Univ Francisco Vitoria, Fac Med, Madrid 28223, Spain
[6] Clin Univ Navarra CUN, Madrid 28027, Spain
[7] Univ Autonoma Madrid, Rey Juan Carlos Univ Hosp HURJC, FJD Hlth Res Inst, UAM,IIS,FJD, Madrid 28933, Spain
[8] A Coruna Univ Hosp Complex, Internal Med Dept, La Coruna 15006, Spain
[9] Quironsalud Hosp A Coruna, La Coruna 15009, Spain
关键词
COVID-19; pneumonia; hyperinflammation; cyclosporin A; randomized controlled trial; MITOCHONDRIAL; INFECTION;
D O I
10.3390/jcm13175242
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
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页数:11
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