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Evaluation of the Efficacy of Sofosbuvir Plus Daclatasvir in Combination With Ribavirin for Hospitalized Covid-19 Patients With Moderate Disease Compared With Standard Care: A Single-Centre, Randomized Controlled Trial Publisher Pubmed



Kasgari HA1 ; Moradi S2 ; Shabani AM1 ; Babamahmoodi F3 ; Davoudi Badabi AR3 ; Davoudi L3 ; Alikhani A3 ; Omran AH4 ; Saeedi M5 ; Merat S6 ; Wentzel H7 ; Garratt A8 ; Levi J9 ; Simmons B10 Show All Authors
Authors
  1. Kasgari HA1
  2. Moradi S2
  3. Shabani AM1
  4. Babamahmoodi F3
  5. Davoudi Badabi AR3
  6. Davoudi L3
  7. Alikhani A3
  8. Omran AH4
  9. Saeedi M5
  10. Merat S6
  11. Wentzel H7
  12. Garratt A8
  13. Levi J9
  14. Simmons B10
  15. Hill A11
  16. Fakheri HT12
Show Affiliations
Authors Affiliations
  1. 1. Department of Clinical Pharmacy, School of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran
  2. 2. Education Development Center, Mazandaran University of Medical Sciences, Sari, Iran
  3. 3. Antimicrobial Resistance Research Center, Mazandaran University of Medical Sciences, Sari, Iran
  4. 4. Gastrointestinal Cancer Research Center, Cancer Research Institute, Mazandaran University of Medical Sciences, Sari, Iran
  5. 5. Pharmaceutical Sciences Research Center, Hemoglobinopathy Research Institute, Mazandaran University of Medical Sciences, Sari, Iran
  6. 6. Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran
  7. 7. School of Public Health, Imperial College London, London, United Kingdom
  8. 8. Cardiff and Vale University Health Board, Cardiff, United Kingdom
  9. 9. Accident and Emergency Department, Homerton University Hospital NHS Trust, London, United Kingdom
  10. 10. Department of Infectious Disease, Imperial College London, London, United Kingdom
  11. 11. Department of Translational Medicine, University of Liverpool, United Kingdom
  12. 12. Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran

Source: Journal of Antimicrobial Chemotherapy Published:2020


Abstract

Background: New therapeutic options are urgently needed to tackle the novel coronavirus disease 2019 (COVID-19). Repurposing existing pharmaceuticals provides an immediate treatment opportunity. We assessed the efficacy of sofosbuvir and daclatasvir with ribavirin for treating patients with COVID-19. Methods: This was a single-centre, randomized controlled trial in adults with moderate COVID-19 admitted to the Ghaem Shahr Razi Hospital in Mazandaran Province, Iran. Patients were randomly assigned to 400 mg sofosbuvir, 60 mg daclatasvir and 1200 mg ribavirin (intervention group) or to standard care (control group). The primary endpoint of this study was length of hospital stay. This study is registered by IRCT.ir under the ID: IRCT20200328046886N1. Results: Between 20 March 2020 and 8 April 2020, 48 patients were recruited; 24 patients were randomly assigned to the intervention group and 24 to the control group. The median duration of hospital stay was 6 days in both groups (P = 0.398). The number of ICU admissions in the sofosbuvir/daclatasvir/ribavirin group was not significantly lower than the control group (0 versus 4, P = 0.109). There was no difference in the number of deaths between the groups (0 versus 3, P = 0.234). The cumulative incidence of recovery was higher in the sofosbuvir/daclatasvir/ribavirin arm (Gray's P = 0.033). Conclusions: This randomized trial was too small to make definitive conclusions. There were trends in favour of the sofosbuvir/daclatasvir/ribavirin arm for recovery and lower death rates. However, there was an imbalance in the baseline characteristics between the arms. Larger randomized trials should be conducted to investigate this treatment further. © The Author(s) 2020. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved.
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