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10.1016/j.ijid.2020.11.142

http://scihub22266oqcxt.onion/10.1016/j.ijid.2020.11.142
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suck abstract from ncbi


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pmid33212256      Int+J+Infect+Dis 2021 ; 103 (ä): 62-71
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  • Efficacy and safety of favipiravir, an oral RNA-dependent RNA polymerase inhibitor, in mild-to-moderate COVID-19: A randomized, comparative, open-label, multicenter, phase 3 clinical trial #MMPMID33212256
  • Udwadia ZF; Singh P; Barkate H; Patil S; Rangwala S; Pendse A; Kadam J; Wu W; Caracta CF; Tandon M
  • Int J Infect Dis 2021[Feb]; 103 (ä): 62-71 PMID33212256show ga
  • OBJECTIVE: To assess the efficacy and safety of favipiravir in adults with mild-to-moderate coronavirus disease 2019 (COVID-19). METHODS: In this randomized, open-label, parallel-arm, multicenter, phase 3 trial, adults (18-75 years) with RT-PCR confirmed COVID-19 and mild-to-moderate symptoms (including asymptomatic) were randomized 1:1 to oral favipiravir (day 1: 1800 mg BID and days 2-14: 800 mg BID) plus standard supportive care versus supportive care alone. The primary endpoint was time to the cessation of viral shedding; time to clinical cure was also measured. RESULTS: From May 14 to July 3, 2020, 150 patients were randomized to favipiravir (n = 75) or control (n = 75). Median time to the cessation of viral shedding was 5 days (95% CI: 4 days, 7 days) versus 7 days (95% CI: 5 days, 8 days), P = 0.129, and median time to clinical cure was 3 days (95% CI: 3 days, 4 days) versus 5 days (95% CI: 4 days, 6 days), P = 0.030, for favipiravir and control, respectively. Adverse events were observed in 36% of favipiravir and 8% of control patients. One control patient died due to worsening disease. CONCLUSION: The lack of statistical significance on the primary endpoint was confounded by limitations of the RT-PCR assay. Significant improvement in time to clinical cure suggests favipiravir may be beneficial in mild-to-moderate COVID-19.
  • |*COVID-19 Drug Treatment[MESH]
  • |*SARS-CoV-2[MESH]
  • |Adolescent[MESH]
  • |Adult[MESH]
  • |Aged[MESH]
  • |Amides/adverse effects/*therapeutic use[MESH]
  • |Female[MESH]
  • |Humans[MESH]
  • |Male[MESH]
  • |Middle Aged[MESH]
  • |Pyrazines/adverse effects/*therapeutic use[MESH]
  • |RNA-Dependent RNA Polymerase/*antagonists & inhibitors[MESH]


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