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
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..
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:103 |
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| Enthalten in: |
International Journal of Infectious Diseases - 103(2021), Seite 62-71 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Zarir F. Udwadia [VerfasserIn] |
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| Links: |
doi.org [kostenfrei] |
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| Themen: |
Antiviral |
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| doi: |
10.1016/j.ijid.2020.11.142 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
DOAJ053858700 |
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| 245 | 1 | 0 | |a 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 |
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| 520 | |a 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. | ||
| 650 | 4 | |a Favipiravir | |
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| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a Coronavirus | |
| 650 | 4 | |a Antiviral | |
| 650 | 4 | |a Randomized clinical trial | |
| 653 | 0 | |a Infectious and parasitic diseases | |
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| 700 | 0 | |a Hanmant Barkate |e verfasserin |4 aut | |
| 700 | 0 | |a Saiprasad Patil |e verfasserin |4 aut | |
| 700 | 0 | |a Shabbir Rangwala |e verfasserin |4 aut | |
| 700 | 0 | |a Amol Pendse |e verfasserin |4 aut | |
| 700 | 0 | |a Jatin Kadam |e verfasserin |4 aut | |
| 700 | 0 | |a Wen Wu |e verfasserin |4 aut | |
| 700 | 0 | |a Cynthia F. Caracta |e verfasserin |4 aut | |
| 700 | 0 | |a Monika Tandon |e verfasserin |4 aut | |
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