Evaluation of the effect of sofosbuvir and daclatasvir in hospitalized COVID-19 patients: a randomized double-blind clinical trial (DISCOVER).

Autor:	Mobarak S; Abadan University of Medical Sciences, Abadan, Iran., Salasi M; Imam Khomeini Hospital of Abadan Petroleum Health Organization, Abadan, Iran., Hormati A; Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran.; Gastroenterology and Hepatology Disease Research Center, Qom University of Medical Sciences, Qom, Iran., Khodadadi J; Infectious Disease Department, Qom University of Medical Sciences, Qom, Iran., Ziaee M; Infectious Diseases Research Center, Birjand University of Medical Sciences, Birjand, Iran., Abedi F; Infectious Diseases Research Center, Birjand University of Medical Sciences, Birjand, Iran., Ebrahimzadeh A; Infectious Diseases Research Center, Birjand University of Medical Sciences, Birjand, Iran., Azarkar Z; Infectious Diseases Research Center, Birjand University of Medical Sciences, Birjand, Iran., Mansour-Ghanaei F; Gastrointestinal and Liver Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran., Joukar F; Gastrointestinal and Liver Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran., Yeganeh S; Caspian Digestive Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran., Yaghubi Kalurazi T; Department of Health, Nutrition & Infectious Diseases, Guilan University of Medical Sciences, Rasht, Iran., Naghipour M; Gastrointestinal and Liver Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran., Mehrabi Z; Department of Infectious Diseases, Shiraz University of Medical Sciences, Shiraz, Iran., Bahadori AR; Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran., Yaghoubi S; Department of Infectious Diseases, Shiraz University of Medical Sciences, Shiraz, Iran., Moslemi R; Department of Clinical Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran., Abbaspour Kasgari H; Department of Clinical Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran., Fakheri H; Gut and Liver Research Center, Non-communicable Disease Institute, Mazandaran University of Medical Sciences, Sari, Iran., Moghimi M; Department of Clinical Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran., Shabani AM; Department of Clinical Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran., Nekoukar Z; Department of Clinical Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran., Babamahmoodi F; Antimicrobial Resistance Research Center, Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran., Davoudi Badabi AR; Antimicrobial Resistance Research Center, Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran., Davoodi L; Antimicrobial Resistance Research Center, Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran., Hassaniazad M; Infectious and Tropical Diseases Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran., Barahimi E; Infectious and Tropical Diseases Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran., Tousi A; Student Research Committee, Hormozgan University of Medical Sciences, Bandar Abbas, Iran., Sadeghi A; Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran., Hosamirudsari H; Infectious Diseases Department, Tehran University of Medical Sciences, Tehran, Iran., Ali Asgari A; Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran., Abdollahi M; Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran., Anushiravani A; Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran., Shabani M; Department of Infectious Diseases and Tropical Medicine, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran., Shokouhi S; Department of Infectious Diseases and Tropical Medicine, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran., Khajavirad N; Department of Internal Medicine, Tehran University of Medical Sciences, Tehran, Iran., Salehi M; Infectious Diseases Department, Tehran University of Medical Sciences, Tehran, Iran., Dehghan Manshadi SA; Infectious Diseases Department, Tehran University of Medical Sciences, Tehran, Iran., Mousavi H; Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran., Zolfaghari F; Student Research Committee, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran., Azimi E; Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran., Zeinali A; Department of Cardiology, Tehran University of Medical Sciences, Tehran, Iran., Akbarpour E; Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran., Merat D; Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran., Eslami G; Abadan University of Medical Sciences, Abadan, Iran., Mousaviasl S; Abadan University of Medical Sciences, Abadan, Iran., Sayar S; Abadan University of Medical Sciences, Abadan, Iran., Radmanesh E; Abadan University of Medical Sciences, Abadan, Iran., Ebrahimzadeh M; Abadan University of Medical Sciences, Abadan, Iran., Arizavi Z; Abadan University of Medical Sciences, Abadan, Iran., Jelvay S; Abadan University of Medical Sciences, Abadan, Iran., Salmanzadeh S; Abadan University of Medical Sciences, Abadan, Iran., Esmaeilian H; Abadan University of Medical Sciences, Abadan, Iran., Mobarak M; Abadan University of Medical Sciences, Abadan, Iran., Karimi J; Department of Infectious Disease, Fasa University of Medical Sciences, Fasa, Iran., Poormontaseri Z; Department of Infectious Disease, Fasa University of Medical Sciences, Fasa, Iran., Hasooni Bahrini N; Imam Khomeini Hospital of Abadan Petroleum Health Organization, Abadan, Iran., Bonyadi A; Imam Khomeini Hospital of Abadan Petroleum Health Organization, Abadan, Iran., Dehghani F; Imam Khomeini Hospital of Abadan Petroleum Health Organization, Abadan, Iran., Mirzaei H; Department of Biotechnology, School of Medicine, Zabol University of Medical Sciences, Zabol, Iran., Noori Jangi M; Department of Infectious Diseases, School of Medicine, Zabol University of Medical Sciences, Zabol, Iran., Pourmasoomi H; Department of Infectious Diseases, School of Medicine, Zabol University of Medical Sciences, Zabol, Iran., Rezaie Keikhaie L; Department of Infectious Diseases, School of Medicine, Zabol University of Medical Sciences, Zabol, Iran., Afshari M; Pediatric Gastroenterology and Hepatology Research Center, Zabol University of Medical Sciences, Zabol, Iran., Nateghi Baygi A; Research and Development Department, Fanavaran Rojan Mohaghegh Darou Co., Tehran, Iran., Nateghi Baygi H; Research and Development Department, Fanavaran Rojan Mohaghegh Darou Co., Tehran, Iran., Levi J; Department of Intensive Care, University College London Hospital, London, UK., McCann K; School of Public Health, Imperial College London, London, UK., Wentzel H; School of Public Health, Imperial College London, London, UK., Simmons B; Department of Infectious Diseases, Imperial College London, London, UK., Hill A; Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK., Merat S; Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
Jazyk:	angličtina
Zdroj:	The Journal of antimicrobial chemotherapy [J Antimicrob Chemother] 2022 Feb 23; Vol. 77 (3), pp. 758-766.
DOI:	10.1093/jac/dkab433
Abstrakt:	Background: The combination of sofosbuvir and daclatasvir has shown preliminary efficacy for hospitalized patients with COVID-19 in four open-label studies with small sample sizes. This larger trial aimed to assess if the addition of sofosbuvir/daclatasvir to standard care improved clinical outcomes in hospitalized patients with COVID-19. Methods: This was a placebo-controlled, double-blind, randomized clinical trial in adults hospitalized with COVID-19 at 19 hospitals in Iran. Patients were randomized to oral sofosbuvir/daclatasvir 400/60 mg once-daily or placebo in addition to standard of care. Patients were included if they had positive PCR or diagnostic chest CT, O2 saturation <95% and compatible symptoms. The primary outcome was hospital discharge within 10 days of randomization. Secondary outcomes included mortality and time to clinical events. The trial is registered on the Iran Registry of Clinical Trials under IRCT20200624047908N1. Results: Between July and October 2020, 1083 patients were randomized to either the sofosbuvir/daclatasvir arm (n = 541) or the placebo arm (n = 542). No significant difference was observed in the primary outcome of hospital discharge within 10 days, which was achieved by 415/541 (77%) in the sofosbuvir/daclatasvir arm and 411/542 (76%) in the placebo arm [risk ratio (RR) 1.01, 95% CI 0.95-1.08, P = 0.734]. In-hospital mortality was 60/541 (11%) in the sofosbuvir/daclatasvir arm versus 55/542 (10%) in the placebo arm (RR 1.09, 95% CI 0.77-1.54, P = 0.615). No differences were observed in time to hospital discharge or time to in-hospital mortality. Conclusions: We observed no significant effect of sofosbuvir/daclatasvir versus placebo on hospital discharge or survival in hospitalized COVID-19 patients. (© The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
Databáze:	MEDLINE
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