An Open Label Randomized Controlled Trial of Ivermectin Plus Favipiravir-Based Standard of Care versus Favipiravir-Based Standard of Care for Treatment of Moderate COVID-19 in Thailand

Sarojvisut Phahol; Apisarnthanarak Anucha; Jantarathaneewat Kittiya; Sathitakorn Ornnicha; Pienthong Thanus; Mingmalairak Chatchai; Warren David K; Weber David J

doi:10.3947/ic.2022.0127

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저자정보: Sarojvisut Phahol (Department of Internal Medicine Faculty of Medicine Thammasat University Pathum Thani Thailand.) Apisarnthanarak Anucha (Department of Internal Medicine Faculty of Medicine Thammasat University Pathum Thani Thailand.Research Group in Infectious Diseases Epidemiology and Prevention Faculty of Medicine Thammasat Universit) Jantarathaneewat Kittiya (Research Group in Infectious Diseases Epidemiology and Prevention Faculty of Medicine Thammasat University Pathum Thani Thailand.Center of Excellence in Pharmacy Practice and Management Research Facul) Sathitakorn Ornnicha (Department of Internal Medicine Faculty of Medicine Thammasat University Pathum Thani Thailand.) Pienthong Thanus (Department of Internal Medicine Faculty of Medicine Thammasat University Pathum Thani Thailand.) Mingmalairak Chatchai (Department of Surgery Faculty of Medicine Thammasat University Pathum Thani Thailand.) Warren David K (Division of Infectious Diseases Washington University School of Medicine St. Louis MO USA.) Weber David J (Gillings School of Global Public Health University of North Carolina Chapel Hill NC USA.)

저널정보: 대한감염학회 Infection and Chemotherapy Infection and Chemotherapy 제55권 제1호

발행연도: 2023.3

수록면: 50 - 58 (9page)

DOI: 10.3947/ic.2022.0127

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Background The role of ivermectin in the treatment of moderate coronavirus disease 2019 (COVID-19) is controversial. We performed an open label randomized controlled trial to evaluate the role of ivermectin plus favipiravir-based standard of care versus favipiravir-based standard of care for the treatment of moderate COVID-19 infection. Materials and Methods An open-label randomized control trial was performed at Thammasat Field Hospital and Thammasat University Hospital from October 1st, 2021 to May 31st, 2022. Patients with moderate COVID-19 infections were randomized to the intervention (ivermectin plus favipiravir-based standard of care) or control group (favipiravir-based standard of care alone). Patients were followed up to 21 days. The primary outcome was the improvement in World Health Organization (WHO) category ordinal scale by 2 points. Secondary outcomes included duration of illness, development of severe COVID-19, and adverse reactions. Results There were 157 patients in the intervention and 160 patients in the control group. Characteristics, underlying diseases, and risk factors for severe COVID-19 were comparable in both groups. Improvement in the WHO-category ordinal scale by 2 points was achieved in 98.7% of the intervention group and in 99.4% of the control group (relative risk [RR]: 0.487; 95% confidence interval [CI]: 0.044-5.430). The median illness duration was 5.0 days (range, 3 - 28 days) in intervention group versus 5.2 days (range, 3 - 28 days) in control group (P = 0.630). Severe COVID-19 that required intensive care occurred in 2 patients (1.3%) in the intervention group and 1 patient (0.6%) in the control group (RR: 2.052; 95% CI: 0.184 - 22.857). No significant difference in serious drug adverse events was seen. Conclusion In this study ivermectin plus standard of care was not associated with improvement in the WHO-category ordinal scale, reduced illness duration, or development of severe COVID-19 in moderately ill COVID-19 patients. Trial Registration Clinicaltrials.gov Identifier: TCTR20220427005

Background The role of ivermectin in the treatment of moderate coronavirus disease 2019 (COVID-19) is controversial. We performed an open label randomized controlled trial to evaluate the role of ivermectin plus favipiravir-based standard of care versus favipiravir-based standard of care for the treatment of moderate COVID-19 infection. Materials and Methods An open-label randomized control trial was performed at Thammasat Field Hospital and Thammasat University Hospital from October 1st, 2021 to May 31st, 2022. Patients with moderate COVID-19 infections were randomized to the intervention (ivermectin plus favipiravir-based standard of care) or control group (favipiravir-based standard of care alone). Patients were followed up to 21 days. The primary outcome was the improvement in World Health Organization (WHO) category ordinal scale by 2 points. Secondary outcomes included duration of illness, development of severe COVID-19, and adverse reactions. Results There were 157 patients in the intervention and 160 patients in the control group. Characteristics, underlying diseases, and risk factors for severe COVID-19 were comparable in both groups. Improvement in the WHO-category ordinal scale by 2 points was achieved in 98.7% of the intervention group and in 99.4% of the control group (relative risk [RR]: 0.487; 95% confidence interval [CI]: 0.044-5.430). The median illness duration was 5.0 days (range, 3 - 28 days) in intervention group versus 5.2 days (range, 3 - 28 days) in control group (P = 0.630). Severe COVID-19 that required intensive care occurred in 2 patients (1.3%) in the intervention group and 1 patient (0.6%) in the control group (RR: 2.052; 95% CI: 0.184 - 22.857). No significant difference in serious drug adverse events was seen. Conclusion In this study ivermectin plus standard of care was not associated with improvement in the WHO-category ordinal scale, reduced illness duration, or development of severe COVID-19 in moderately ill COVID-19 patients. Trial Registration Clinicaltrials.gov Identifier: TCTR20220427005

#Ivermectin #Favipiravir #COVID-19 #Treatment #Thailand

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Sarojvisut Phahol

소속기관 Department of Internal Medicine Faculty of Medicine Thammasat University Pathum Thani Thailand.

주요연구분야 의약학 > 임상의학 > 내과학

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Apisarnthanarak Anucha

소속기관 Department of Internal Medicine Faculty of Medicine Thammasat University Pathum Thani Thailand.Research Group in Infectious Diseases Epidemiology and Prevention Faculty of Medicine Thammasat Universit

주요연구분야 의약학 > 임상의학 > 내과학

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Jantarathaneewat Kittiya

소속기관 Research Group in Infectious Diseases Epidemiology and Prevention Faculty of Medicine Thammasat University Pathum Thani Thailand.Center of Excellence in Pharmacy Practice and Management Research Facul

주요연구분야 의약학 > 임상의학 > 내과학

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Sathitakorn Ornnicha

소속기관 Department of Internal Medicine Faculty of Medicine Thammasat University Pathum Thani Thailand.

주요연구분야 의약학 > 임상의학 > 내과학

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Pienthong Thanus

소속기관 Department of Internal Medicine Faculty of Medicine Thammasat University Pathum Thani Thailand.

주요연구분야 의약학 > 임상의학 > 내과학

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Mingmalairak Chatchai

소속기관 Department of Surgery Faculty of Medicine Thammasat University Pathum Thani Thailand.

주요연구분야 의약학 > 임상의학 > 내과학

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Warren David K

소속기관 Division of Infectious Diseases Washington University School of Medicine St. Louis MO USA.

주요연구분야 의약학 > 임상의학 > 내과학

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Weber David J

소속기관 Gillings School of Global Public Health University of North Carolina Chapel Hill NC USA.

주요연구분야 의약학 > 임상의학 > 내과학

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