Literature DB >> 32359035

Pilot prospective open, single-arm multicentre study on off-label use of tocilizumab in patients with severe COVID-19.

Savino Sciascia1, Franco Aprà2, Alessandra Baffa1, Simone Baldovino1, Daniela Boaro2, Roberto Boero2, Stefano Bonora2, Andrea Calcagno2, Irene Cecchi1, Giacoma Cinnirella2, Marcella Converso2, Martina Cozzi1, Paola Crosasso2, Fabio De Iaco2, Giovanni Di Perri2, Mario Eandi2, Roberta Fenoglio1, Massimo Giusti2, Daniele Imperiale2, Gianlorenzo Imperiale2, Sergio Livigni2, Emilpaolo Manno2, Carlo Massara1, Valeria Milone2, Giuseppe Natale2, Mauro Navarra2, Valentina Oddone1, Sara Osella2, Pavilio Piccioni2, Massimo Radin1, Dario Roccatello3, Daniela Rossi1.   

Abstract

OBJECTIVES: No agent has yet been proven to be effective for the treatment of patients with severe COVID-19.
METHODS: We conducted a pilot prospective open, single-arm multicentre study on off-label use of tocilizumab (TCZ) involving 63 hospitalised adult patients (56 males, age 62.6±12.5) with severe COVID-19. Clinical and laboratory parameters were prospectively collected at baseline, day 1, 2, 7 and 14. No moderate-to-severe adverse events attributable to TCZ were recorded.
RESULTS: We observed a significant improvement in the levels of ferritin, C-reactive protein, D-dimer. The ratio of the partial pressure of oxygen (Pa02) to the fraction of inspired oxygen (Fi02) improved (mean±SD Pa02/Fi02 at admission: 152±53; at day 7: 283.73±115.9, at day 14: 302.2±126, p<0.05). The overall mortality was 11%; D-dimer level at baseline, but not IL-6 levels were predictors of mortality. TCZ administration within 6 days from admission in the hospital was associated with an increased likelihood of survival (HR 2.2 95%CI 1.3-6.7, p<0.05).
CONCLUSIONS: In hospitalised adult patients with severe COVID-19, TCZ could be a safe option. An improvement in respiratory and laboratory parameters was observed. Future controlled trials in patients with severe illness are urgently needed to confirm the definite benefit with IL-6 target therapy.

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Year:  2020        PMID: 32359035

Source DB:  PubMed          Journal:  Clin Exp Rheumatol        ISSN: 0392-856X            Impact factor:   4.473


  130 in total

1.  Reply to Wang et al.: Tocilizumab treatment should be used in a timely manner, at suitable dose, and in suitable patients.

Authors:  Xiaoling Xu; Mingfeng Han; Tiantian Li; Wei Sun; Dongsheng Wang; Binqing Fu; Yonggang Zhou; Xiaohu Zheng; Yun Yang; Xiuyong Li; Xiaohua Zhang; Aijun Pan; Haiming Wei
Journal:  Proc Natl Acad Sci U S A       Date:  2020-11-17       Impact factor: 11.205

Review 2.  Current Evidence of Interleukin-6 Signaling Inhibitors in Patients With COVID-19: A Systematic Review and Meta-Analysis.

Authors:  Qi Han; Mingyue Guo; Yue Zheng; Ying Zhang; Yanshan De; Changchang Xu; Lin Zhang; Ruru Sun; Ying Lv; Yan Liang; Feng Xu; Jiaojiao Pang; Yuguo Chen
Journal:  Front Pharmacol       Date:  2020-12-15       Impact factor: 5.810

Review 3.  Potential COVID-19 Therapeutic Agents and Vaccines: An Evidence-Based Review.

Authors:  Elnaz Khani; Sajad Khiali; Taher Entezari-Maleki
Journal:  J Clin Pharmacol       Date:  2021-03-05       Impact factor: 3.126

4.  Effect of Tocilizumab vs Standard Care on Clinical Worsening in Patients Hospitalized With COVID-19 Pneumonia: A Randomized Clinical Trial.

Authors:  Carlo Salvarani; Giovanni Dolci; Marco Massari; Domenico Franco Merlo; Silvio Cavuto; Luisa Savoldi; Paolo Bruzzi; Fabrizio Boni; Luca Braglia; Caterina Turrà; Pier Ferruccio Ballerini; Roberto Sciascia; Lorenzo Zammarchi; Ombretta Para; Pier Giorgio Scotton; Walter Omar Inojosa; Viviana Ravagnani; Nicola Duccio Salerno; Pier Paolo Sainaghi; Alessandro Brignone; Mauro Codeluppi; Elisabetta Teopompi; Maurizio Milesi; Perla Bertomoro; Norbiato Claudio; Mario Salio; Marco Falcone; Giovanni Cenderello; Lorenzo Donghi; Valerio Del Bono; Paolo Luigi Colombelli; Andrea Angheben; Angelina Passaro; Giovanni Secondo; Renato Pascale; Ilaria Piazza; Nicola Facciolongo; Massimo Costantini
Journal:  JAMA Intern Med       Date:  2021-01-01       Impact factor: 21.873

5.  Reply to Yang et al.: Tocilizumab treatment in COVID-19 patients needs the assessment of the disease severity and timely intervention.

Authors:  Xiaoling Xu; Mingfeng Han; Tiantian Li; Wei Sun; Dongsheng Wang; Binqing Fu; Yonggang Zhou; Xiaohu Zheng; Yun Yang; Xiuyong Li; Xiaohua Zhang; Aijun Pan; Haiming Wei
Journal:  Proc Natl Acad Sci U S A       Date:  2020-11-12       Impact factor: 11.205

6.  Safety concerns regarding concomitant use of tocilizumab and glucocorticoids in COVID-19 patients.

Authors:  Chengliang Yang; Elizabeth Liu; Mingyao Liu
Journal:  Proc Natl Acad Sci U S A       Date:  2020-11-12       Impact factor: 11.205

7.  Demographic & clinical profile of patients with COVID-19 at a tertiary care hospital in north India.

Authors:  Shiv Lal Soni; Kamal Kajal; L N Yaddanapudi; Pankaj Malhotra; Goverdhan Dutt Puri; Ashish Bhalla; Mini P Singh; Inderpaul Singh Sehgal; Vipin Koushal; Neelam Varma; Manisha Biswal; P V M Lakshmi; Sadhna Sharma; Vikas Suri; Z Deepy; Sant Ram; Jaivinder Yadav; Navin Pandey; Prashant Sharma; Nabhajit Malik; Kapil Goyal; Aseem Mehra; Swapnajeet Sahoo; Ritin Mohindra; Jijo Francis; Mudit Bhargava; Karan Singla; Preena Babu; Amiy Verma; Niranjan Shiwaji Khaire; R R Guru
Journal:  Indian J Med Res       Date:  2021 Jan & Feb       Impact factor: 2.375

8.  Sacubitril-valsartan improves conduit vessel function and functional capacity and reduces inflammation in heart failure with reduced ejection fraction.

Authors:  Kanokwan Bunsawat; Stephen M Ratchford; Jeremy K Alpenglow; Soung Hun Park; Catherine L Jarrett; Josef Stehlik; Adam S Smith; Russell S Richardson; D Walter Wray
Journal:  J Appl Physiol (1985)       Date:  2020-11-19

9.  Association Between Early Treatment With Tocilizumab and Mortality Among Critically Ill Patients With COVID-19.

Authors:  Shruti Gupta; Wei Wang; Salim S Hayek; Lili Chan; Kusum S Mathews; Michal L Melamed; Samantha K Brenner; Amanda Leonberg-Yoo; Edward J Schenck; Jared Radbel; Jochen Reiser; Anip Bansal; Anand Srivastava; Yan Zhou; Diana Finkel; Adam Green; Mary Mallappallil; Anthony J Faugno; Jingjing Zhang; Juan Carlos Q Velez; Shahzad Shaefi; Chirag R Parikh; David M Charytan; Ambarish M Athavale; Allon N Friedman; Roberta E Redfern; Samuel A P Short; Simon Correa; Kapil K Pokharel; Andrew J Admon; John P Donnelly; Hayley B Gershengorn; David J Douin; Matthew W Semler; Miguel A Hernán; David E Leaf
Journal:  JAMA Intern Med       Date:  2021-01-01       Impact factor: 21.873

Review 10.  The Current Status and Challenges in the Development of Vaccines and Drugs against Severe Acute Respiratory Syndrome-Corona Virus-2 (SARS-CoV-2).

Authors:  Narasimha M Beeraka; SubbaRao V Tulimilli; Medha Karnik; Surya P Sadhu; Rajeswara Rao Pragada; Gjumrakch Aliev; SubbaRao V Madhunapantula
Journal:  Biomed Res Int       Date:  2021-06-01       Impact factor: 3.411

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