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      Efficacy of favipiravir in COVID-19 treatment: a multi-center randomized study

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          Abstract

          No specific antiviral drugs have been approved for the treatment of COVID-19. This study aimed to evaluate the efficacy of favipiravir in treatment of COVID-19. This was a multicenter randomized controlled study including 96 patients with COVID- 19 who were randomly assigned into a chloroquine (CQ) group and a favipiravir group. None of the patients in the favipiravir group needed mechanical ventilation ( p = 0.129). One patient (2.3%) in the favipiravir group and two patients (4.2%) in the CQ group died ( p = 1.00). Favipiravir is a promising drug for COVID-19 that decreases the hospital stay and the need for mechanical ventilation.

          ClinicalTrials.gov Identifier NCT04351295.

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          Most cited references26

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          A Novel Coronavirus from Patients with Pneumonia in China, 2019

          Summary In December 2019, a cluster of patients with pneumonia of unknown cause was linked to a seafood wholesale market in Wuhan, China. A previously unknown betacoronavirus was discovered through the use of unbiased sequencing in samples from patients with pneumonia. Human airway epithelial cells were used to isolate a novel coronavirus, named 2019-nCoV, which formed a clade within the subgenus sarbecovirus, Orthocoronavirinae subfamily. Different from both MERS-CoV and SARS-CoV, 2019-nCoV is the seventh member of the family of coronaviruses that infect humans. Enhanced surveillance and further investigation are ongoing. (Funded by the National Key Research and Development Program of China and the National Major Project for Control and Prevention of Infectious Disease in China.)
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            G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences

            G*Power (Erdfelder, Faul, & Buchner, 1996) was designed as a general stand-alone power analysis program for statistical tests commonly used in social and behavioral research. G*Power 3 is a major extension of, and improvement over, the previous versions. It runs on widely used computer platforms (i.e., Windows XP, Windows Vista, and Mac OS X 10.4) and covers many different statistical tests of the t, F, and chi2 test families. In addition, it includes power analyses for z tests and some exact tests. G*Power 3 provides improved effect size calculators and graphic options, supports both distribution-based and design-based input modes, and offers all types of power analyses in which users might be interested. Like its predecessors, G*Power 3 is free.
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              Experimental Treatment with Favipiravir for COVID-19: An Open-Label Control Study

              An outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and its caused coronavirus disease 2019 (COVID-19) has been reported in China since December 2019. More than 16% of patients developed acute respiratory distress syndrome, and the fatality ratio was about 1%–2%. No specific treatment has been reported. Herein, we examine the effects of Favipiravir (FPV) versus Lopinavir (LPV)/ritonavir (RTV) for the treatment of COVID-19. Patients with laboratory-confirmed COVID-19 who received oral FPV (Day 1: 1600 mg twice daily; Days 2–14: 600 mg twice daily) plus interferon (IFN)-α by aerosol inhalation (5 million U twice daily) were included in the FPV arm of this study, whereas patients who were treated with LPV/RTV (Days 1–14: 400 mg/100 mg twice daily) plus IFN-α by aerosol inhalation (5 million U twice daily) were included in the control arm. Changes in chest computed tomography (CT), viral clearance, and drug safety were compared between the two groups. For the 35 patients enrolled in the FPV arm and the 45 patients in the control arm, all baseline characteristics were comparable between the two arms. A shorter viral clearance time was found for the FPV arm versus the control arm (median (interquartile range, IQR), 4 (2.5–9) d versus 11 (8–13) d, P < 0.001). The FPV arm also showed significant improvement in chest imaging compared with the control arm, with an improvement rate of 91.43% versus 62.22% (P = 0.004). After adjustment for potential confounders, the FPV arm also showed a significantly higher improvement rate in chest imaging. Multivariable Cox regression showed that FPV was independently associated with faster viral clearance. In addition, fewer adverse reactions were found in the FPV arm than in the control arm. In this open-label nonrandomized control study, FPV showed significantly better treatment effects on COVID-19 in terms of disease progression and viral clearance; if causal, these results should be important information for establishing standard treatment guidelines to combat the SARS-CoV-2 infection.
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                Author and article information

                Contributors
                drhdabbous@gmail.com
                sherif.abdelbaky@med.tanta.edu.ed
                manalhelsayed@yahoo.co.uk
                Ahmedfouad85@live.com
                dr.fatma_ebeid@yahoo.com
                mohamed.abdelghafar1@med.tanta.edu.eg
                shaimaasherif@hotmail.com
                drmogabehn@gmail.com
                dr.rb.badawi@gmail.com
                mohamedawadtag@yahoo.com
                Journal
                Arch Virol
                Arch Virol
                Archives of Virology
                Springer Vienna (Vienna )
                0304-8608
                1432-8798
                25 January 2021
                : 1-6
                Affiliations
                [1 ]GRID grid.7269.a, ISNI 0000 0004 0621 1570, Tropical Medicine Department, Faculty of Medicine, , Ain Shams University, ; Cairo, Egypt
                [2 ]GRID grid.412258.8, ISNI 0000 0000 9477 7793, Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine, , Tanta University, ; El-Giash Street, Tanta, 31527 Egypt
                [3 ]GRID grid.7269.a, ISNI 0000 0004 0621 1570, Faculty of Medicine, , Ain Shams University Research Institute-Clinical Research Center (MASRI-CRC), ; Cairo, Egypt
                [4 ]GRID grid.412258.8, ISNI 0000 0000 9477 7793, Department of Anesthesia, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, , Tanta University, ; Tanta, Egypt
                [5 ]GRID grid.411775.1, ISNI 0000 0004 0621 4712, Public Health and Community Medicine, , Menoufia University, ; Menoufia, Egypt
                [6 ]GRID grid.412258.8, ISNI 0000 0000 9477 7793, Emergency Medicine and Traumatology Department, Faculty of Medicine, , Tanta University, ; Tanta, Egypt
                [7 ]GRID grid.7269.a, ISNI 0000 0004 0621 1570, Department of Chest Diseases, Faculty of Medicine, , Ain Shams University, ; Cairo, Egypt
                Author notes

                Handling Editor: Zhongjie Shi.

                Author information
                http://orcid.org/0000-0003-4366-2218
                Article
                4956
                10.1007/s00705-021-04956-9
                7829645
                33492523
                5674839b-426f-4313-a5c1-cd11739901c3
                © The Author(s), under exclusive licence to Springer-Verlag GmbH, AT part of Springer Nature 2021

                This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.

                History
                : 14 October 2020
                : 25 November 2020
                Categories
                Brief Report

                Microbiology & Virology
                Microbiology & Virology

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