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Submitted: 09 Jul 2021
Accepted: 26 Aug 2021
ePublished: 10 Sep 2021
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Immunopathol Persa. Inpress.
doi: 10.34172/ipp.2022.29270
  Abstract View: 1647

Original

Evaluation of Sovodak (sofosbuvir/daclatasvir) treatment outcome in COVID-19 patients compared with Kaletra (lopinavir/ritonavir); a randomized clinical trial

Mahdi Yadollahzadeh 1 ORCID logo, Mohana Eskandari 1 ORCID logo, Maryam Roham 2 ORCID logo, Farhad Zamani 3 ORCID logo, Azadeh Laali 2,4 ORCID logo, Saeed Kalantari 2 ORCID logo, Zeynab Yassin 2 ORCID logo, Erfaneh Movahedi 1 ORCID logo, Mohsen Farrokhpour 1 ORCID logo, Mohamad Taghei Zeiaei 2 ORCID logo, Nima Motamed 5 ORCID logo, Amirhossein Aliakbar 6 ORCID logo, Fatemeh Soleimany 6 ORCID logo, Sajad Karampoor 3,7 ORCID logo, Gholam Hossein Ashrafi 8 ORCID logo, Fahimeh Safarnezhad Tameshkel 3 ORCID logo, Mitra Ranjbar 4* ORCID logo, Mahin Jamshidi Makiani 2,4* ORCID logo, Mohammad Hadi Karbalaie Niya 3,7 ORCID logo

1 Department of Internal Medicine, School of Medicine, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran
2 Antimicrobial Resistant Research Center, Iran University of Medical Sciences, Tehran, Iran
3 Gastrointestinal and Liver Diseases Research Center, Iran University of Medical Sciences, Tehran, IR Iran
4 Department of Infectious Diseases, Iran university of Medical Sciences,Tehran, Iran
5 Department of Social Medicine, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran
6 Department of Biostatistics, Faculty of Public Health, Iran University of Medical Sciences, Tehran, Iran
7 Department of Virology, School of Medicine, Iran University of Medical Sciences, Tehran, Iran
8 Cancer theme SEC Faculty Penrhyn Road, Kingston University London KT1 2EE, United Kingdom
*Corresponding Authors: *Correspondence to Prof. Mitra Ranjbar, Email: , Email: ranjbar.m@ iums.ac.ir; *Correspondence to Prof. Mahin Jamshidi Makiani, Email: , Email: jamshidimakiani.m@ iums.ac.ir

Abstract

Introduction: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) infection and treatment are significant health organizations’ concerns worldwide. Although there is no proven drug license against the virus, a variety of components have under investigation.

Objectives: In this regard, the present study was intended to evaluate the consequences of Sovodak (sofosbuvir/ daclatasvir) treatment in COVID-19 patients compared with Kaletra (lopinavir/ritonavir).

Patients and Methods: This study was conducted as a randomized trial using 120 COVID19 confirmed cases between August 19th and September 19th, 2020, in which subjects were classified into two treatment groups, 58 (Sovodak group) and 54 (Kaletra group). Related statistical operations calculated significant outcomes such as survival rate and hazard ratio by SPSS version 16. Sovodak was composed of sofosbuvir 400mg and daclatasvir 60mg, and Kaletra included lopinavir 400 mg and ritonavir 100 mg.

Results: We observed that there was no significant difference concerning the comorbidities, death, intensive care unit admission, remission. Besides, Kaletra had a higher rate of discharge versus Sovodak [HR=1.551 (95% CI=1.008-2.386), P =0.046] and a better outcome was observed in patients receiving.

Conclusion: Sovodak compared to Kaletra by Hazard plot. Sovodak (sofosbuvir/daclatasvir) therapy in COVID19 cases was accompanied by a significantly higher survival rate and better outcome than Kaletra (lopinavir/ritonavir).

Trial Registration: This study has been registered in the Iranian Registry of Clinical Trials (identifier: IRCT20200328046885N1; https://en.irct.ir/trial/47565, Ethical code #IR.IUMS.FMD.REC.1399.407).


Citation: Yadollahzadeh M, Eskandari M, Roham M, Zamani F, Laali A, Kalantari S, et al. Evaluation of Sovodak (sofosbuvir/daclatasvir) treatment outcome in COVID-19 patients compared with Kaletra (lopinavir/ritonavir); a randomized clinical trial. Immunopathol Persa. 2022;x(x):e29270. DOI:10.34172/ ipp.2022.29270.
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