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
|
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.
引用
收藏
页数:11
相关论文
共 50 条
  • [1] Caution against corticosteroid-based COVID-19 treatment
    Tang, Chong
    Wang, Yichuan
    Lv, Houshan
    Guan, Zhenpeng
    Gu, Jin
    LANCET, 2020, 395 (10239): : 1759 - 1760
  • [2] Efficacy of Nanocurcumin as an Add-On Treatment for Patients Hospitalized with COVID-19: A Double-Blind, Randomized Clinical Trial
    Ahmadi, Sedigheh
    Mehrabi, Zeinab
    Zare, Morteza
    Ghadir, Sara
    Masoumi, Seyed Jalil
    INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, 2023, 2023
  • [3] Add-on inhaled budesonide in the treatment of hospitalised patients with COVID-19: a randomised clinical trial
    Agusti, Alvar
    De Stefano, Gaston
    Levi, Alberto
    Munoz, Xavier
    Romero-Mesones, Christian
    Sibila, Oriol
    Lopez-Giraldo, Alejandra
    Moral, Vicente Plaza
    Curto, Elena
    Echazarreta, Andres L.
    Marquez, Silvana E.
    Pascual-Guardia, Sergi
    Santos, Salud
    Marin, Alicia
    Valdes, Luis
    Saldarini, Fernando
    Salgado, Clara
    Casanovas, Georgina
    Varea, Sara
    Rios, Jose
    Faner, Rosa
    EUROPEAN RESPIRATORY JOURNAL, 2022, 59 (03)
  • [4] Telmisartan for treatment of Covid-19 patients: An open multicenter randomized clinical trial
    Duarte, Mariano
    Pelorosso, Facundo
    Nicolosi, Liliana N.
    Salgado, M. Victoria
    Vetulli, Hector
    Aquieri, Analia
    Azzato, Francisco
    Castro, Marcela
    Coyle, Javier
    Davolos, Ignacio
    Criado, Ignacio Fernandez
    Gregori, Rosana
    Mastrodonato, Pedro
    Rubio, Maria C.
    Sarquis, Sergio
    Wahlmann, Fernando
    Rothlin, Rodolfo P.
    ECLINICALMEDICINE, 2021, 37
  • [5] Acyclovir as a Potential Add-on Therapy in COVID-19 Treatment Regimens
    Heidary, Fatemeh
    Madani, Sedigheh
    Gharebaghi, Reza
    Asadi-Amoli, Fahimeh
    PHARMACEUTICAL SCIENCES, 2021, 27 : S68 - S77
  • [6] Efficacy and safety of colchicine treatment in patients with COVID-19: A prospective, multicenter, randomized clinical trial
    Pourdowlat, Guitti
    Saghafi, Fatemeh
    Mozafari, Abolfazl
    Sahebnasagh, Adeleh
    Abedini, Atefeh
    Nabi Meybodi, Mohsen
    Salehi Nezamabadi, Ali
    Mousavinasab, Seyed Ruhollah
    Kiani, Arda
    Raji, Hanieh
    Soltani, Nadia
    Gholmzadeh Baeis, Mehdi
    Eidani, Esmaeil
    Sadeghi Yakhdani, Abdolrahim
    Movaseghi, Fatemeh
    Habtemariam, Solomon
    Akhoundi Meybodi, Zohreh
    Gholinataj Jelodar, Mohsen
    PHYTOTHERAPY RESEARCH, 2022, 36 (02) : 891 - 898
  • [7] Clinical effectiveness and safety of sofosbuvir-velpatasvir as add-on treatment for COVID-19 patients: Study protocol and preliminary data for the randomized controlled trial
    Sayad, Babak
    Mehrabi, Masomeh
    Khodarahmi, Reza
    Najafi, Farid
    Miladi, Ronak
    Afshar, Zeinab Mohseni
    Mansouri, Feizollah
    Shirvani, Maria
    Salimi, Mehdi
    Shadmani, FatemehKhosravi
    JOURNAL OF REPORTS IN PHARMACEUTICAL SCIENCES, 2021, 10 (02): : 294 - 316
  • [8] Effectiveness of Azithromycin as add-on Therapy in COVID-19 Management
    Wahab, Shadma
    Ahmad, Md Faruque
    Hussain, Arshad
    Usmani, Shazia
    Shoaib, Ambreen
    Ahmad, Wasim
    MINI-REVIEWS IN MEDICINAL CHEMISTRY, 2021, 21 (19) : 2860 - 2873
  • [9] Potential new treatment strategies for COVID-19: is there a role for bromhexine as add-on therapy?
    Markus Depfenhart
    Danielle de Villiers
    Gottfried Lemperle
    Markus Meyer
    Salvatore Di Somma
    Internal and Emergency Medicine, 2020, 15 : 801 - 812
  • [10] Yoga therapy as an add-on treatment in the management of patients with schizophrenia - a randomized controlled trial
    Duraiswamy, G.
    Thirthalli, J.
    Nagendra, H. R.
    Gangadhar, B. N.
    ACTA PSYCHIATRICA SCANDINAVICA, 2007, 116 (03) : 226 - 232