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A Prospective, Randomized, Open-Label Trial of Early versus Late Favipiravir Therapy in Hospitalized Patients with COVID-19.
Doi, Yohei; Hibino, Masaya; Hase, Ryota; Yamamoto, Michiko; Kasamatsu, Yu; Hirose, Masahiro; Mutoh, Yoshikazu; Homma, Yoshito; Terada, Masaki; Ogawa, Taku; Kashizaki, Fumihiro; Yokoyama, Toshihiko; Koba, Hayato; Kasahara, Hideki; Yokota, Kazuhisa; Kato, Hideaki; Yoshida, Junichi; Kita, Toshiyuki; Kato, Yasuyuki; Kamio, Tadashi; Kodama, Nobuhiro; Uchida, Yujiro; Ikeda, Nobuhiro; Shinoda, Masahiro; Nakagawa, Atsushi; Nakatsumi, Hiroki; Horiguchi, Tomoya; Iwata, Mitsunaga; Matsuyama, Akifumi; Banno, Sumi; Koseki, Takenao; Teramachi, Mayumi; Miyata, Masami; Tajima, Shigeru; Maeki, Takahiro; Nakayama, Eri; Taniguchi, Satoshi; Lim, Chang Kweng; Saijo, Masayuki; Imai, Takumi; Yoshida, Hisako; Kabata, Daijiro; Shintani, Ayumi; Yuzawa, Yukio; Kondo, Masashi.
  • Doi Y; Departments of Microbiology and Infectious Diseases, Fujita Health University School of Medicine, Toyoake, Aichi, Japan yoheidoi@fujita-hu.ac.jp.
  • Hibino M; Division of Infectious Diseases, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
  • Hase R; Department of Emergency and General Internal Medicine, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.
  • Yamamoto M; Departments of Microbiology and Infectious Diseases, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.
  • Kasamatsu Y; Department of Infectious Diseases, Japanese Red Cross Narita Hospital, Narita, Chiba, Japan.
  • Hirose M; Department of Respiratory Medicine, Sagamihara Kyodo Hospital, Sagamihara, Kanagawa, Japan.
  • Mutoh Y; Infection Control and Clinical Laboratory, Kyoto Prefectural University of Medicine, Kyoto, Kyoto, Japan.
  • Homma Y; Department of Respiratory Medicine, Fujita Health University Bantane Hospital, Nagoya, Aichi, Japan.
  • Terada M; Department of Infectious Diseases, Tosei General Hospital, Seto, Aichi, Japan.
  • Ogawa T; Department of Respiratory Medicine, Ehime Prefectural Central Hospital, Matsuyama, Ehime, Japan.
  • Kashizaki F; Department of Respiratory Medicine, Saiseikai Niigata Hospital, Niigata, Niigata, Japan.
  • Yokoyama T; Center for Infectious Diseases, Nara Medical University, Kashihara, Nara, Japan.
  • Koba H; Department of Respiratory Medicine, Isehara Kyodo Hospital, Isehara, Kanagawa, Japan.
  • Kasahara H; Department of Respiratory Medicine, Japanese Red Cross Nagoya Daiichi Hospital, Nagoya, Aichi, Japan.
  • Yokota K; Department of Respiratory Medicine, Komatsu Municipal Hospital, Komatsu, Ishikawa, Japan.
  • Kato H; Department of Rheumatology, NTT East Sapporo Hospital, Sapporo, Hokkaido, Japan.
  • Yoshida J; Department of Infectious Diseases, Tokyo Metropolitan Health and Medical Corporation Ebara Hospital, Ohta, Tokyo, Japan.
  • Kita T; Infection Prevention and Control Department, Yokohama City University Hospital, Yokohama, Kanagawa, Japan.
  • Kato Y; Department of Chest Surgery, Shimonoseki City Hospital, Shimonoseki, Yamaguchi, Japan.
  • Kamio T; Department of Respiratory Medicine, National Hospital Organization Kanazawa Medical Center, Kanazawa, Ishikawa, Japan.
  • Kodama N; Department of Infectious Diseases, International University of Health and Welfare Narita Hospital, Narita, Chiba, Japan.
  • Uchida Y; Department of Intensive Care, Shonan Kamakura General Hospital, Kamakura, Kanagawa, Japan.
  • Ikeda N; Department of General Internal Medicine, Fukuoka Tokushukai Hospital, Kasuga, Fukuoka, Japan.
  • Shinoda M; Department of General Medicine, Kitakyushu Municipal Medical Center, Kitakyushu, Fukuoka, Japan.
  • Nakagawa A; Department of General Internal Medicine, Eiju General Hospital, Taito, Tokyo, Japan.
  • Nakatsumi H; Department of Respiratory Medicine, Tokyo Shinagawa Hospital, Shinagawa, Tokyo, Japan.
  • Horiguchi T; Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan.
  • Iwata M; Department of Respiratory Medicine, Ishikawa Prefectural Central Hospital, Kanazawa, Ishikawa, Japan.
  • Matsuyama A; Department of Respiratory Medicine, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.
  • Banno S; Department of Emergency and General Internal Medicine, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.
  • Koseki T; Department of Regenerative Medicine and Stem Cell Biology, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.
  • Teramachi M; Center for Clinical Trial and Research Support, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.
  • Miyata M; Center for Clinical Trial and Research Support, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.
  • Tajima S; Department of Clinical Pharmacy, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.
  • Maeki T; Center for Clinical Trial and Research Support, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.
  • Nakayama E; Center for Clinical Trial and Research Support, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.
  • Taniguchi S; Department of Virology I, National Institute of Infectious Diseases, Shinjuku, Tokyo, Japan.
  • Lim CK; Department of Virology I, National Institute of Infectious Diseases, Shinjuku, Tokyo, Japan.
  • Saijo M; Department of Virology I, National Institute of Infectious Diseases, Shinjuku, Tokyo, Japan.
  • Imai T; Department of Virology I, National Institute of Infectious Diseases, Shinjuku, Tokyo, Japan.
  • Yoshida H; Department of Virology I, National Institute of Infectious Diseases, Shinjuku, Tokyo, Japan.
  • Kabata D; Department of Virology I, National Institute of Infectious Diseases, Shinjuku, Tokyo, Japan.
  • Shintani A; Department of Medical Statistics, Osaka City University Graduate School of Medicine, Osaka, Osaka, Japan.
  • Yuzawa Y; Department of Medical Statistics, Osaka City University Graduate School of Medicine, Osaka, Osaka, Japan.
  • Kondo M; Department of Medical Statistics, Osaka City University Graduate School of Medicine, Osaka, Osaka, Japan.
Antimicrob Agents Chemother ; 64(12)2020 11 17.
Article in English | MEDLINE | ID: covidwho-939841
Semantic information from SemMedBD (by NLM)
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Subject
favipiravir
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2. COVID-19 PROCESS_OF hospitalized patients
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hospitalized patients
3. favipiravir TREATS hospitalized patients
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4. Inhibitor PART_OF RNA-Directed RNA Polymerase
Subject
Inhibitor
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5. favipiravir TREATS Influenza
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favipiravir
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6. Hospitals LOCATION_OF Multicenter Trials
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7. favipiravir TREATS Patients
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favipiravir
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8. Fever PROCESS_OF Patients
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9. Reverse Transcriptase Polymerase Chain Reaction MEASURES favipiravir
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10. Cessation of life PROCESS_OF Treatment Group
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11. favipiravir TREATS COVID-19
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13. favipiravir TREATS hospitalized patients
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14. Inhibitor PART_OF RNA-Directed RNA Polymerase
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15. favipiravir TREATS Influenza
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16. Hospitals LOCATION_OF Multicenter Trials
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19. Reverse Transcriptase Polymerase Chain Reaction MEASURES favipiravir
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20. Cessation of life PROCESS_OF Treatment Group
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ABSTRACT
Favipiravir is an oral broad-spectrum inhibitor of viral RNA-dependent RNA polymerase that is approved for treatment of influenza in Japan. We conducted a prospective, randomized, open-label, multicenter trial of favipiravir for the treatment of COVID-19 at 25 hospitals across Japan. Eligible patients were adolescents and adults admitted with COVID-19 who were asymptomatic or mildly ill and had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Patients were randomly assigned at a 11 ratio to early or late favipiravir therapy (in the latter case, the same regimen starting on day 6 instead of day 1). The primary endpoint was viral clearance by day 6. The secondary endpoint was change in viral load by day 6. Exploratory endpoints included time to defervescence and resolution of symptoms. Eighty-nine patients were enrolled, of whom 69 were virologically evaluable. Viral clearance occurred within 6 days in 66.7% and 56.1% of the early and late treatment groups (adjusted hazard ratio [aHR], 1.42; 95% confidence interval [95% CI], 0.76 to 2.62). Of 30 patients who had a fever (≥37.5°C) on day 1, times to defervescence were 2.1 days and 3.2 days in the early and late treatment groups (aHR, 1.88; 95% CI, 0.81 to 4.35). During therapy, 84.1% developed transient hyperuricemia. Favipiravir did not significantly improve viral clearance as measured by reverse transcription-PCR (RT-PCR) by day 6 but was associated with numerical reduction in time to defervescence. Neither disease progression nor death occurred in any of the patients in either treatment group during the 28-day participation. (This study has been registered with the Japan Registry of Clinical Trials under number jRCTs041190120.).
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Main subject: Antiviral Agents / Pyrazines / Viral Load / Amides / SARS-CoV-2 / COVID-19 Subject: Antiviral Agents / Pyrazines / Viral Load / Amides / SARS-CoV-2 / COVID-19 Type of study: Controlled clinical trial / Diagnostic study / Observational study / Risk factors Language: English Clinical aspect: Therapy Year: 2020

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Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Main subject: Antiviral Agents / Pyrazines / Viral Load / Amides / SARS-CoV-2 / COVID-19 Subject: Antiviral Agents / Pyrazines / Viral Load / Amides / SARS-CoV-2 / COVID-19 Type of study: Controlled clinical trial / Diagnostic study / Observational study / Risk factors Language: English Clinical aspect: Therapy Year: 2020
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