Multicenter, single-blind, randomized controlled study of the efficacy and safety of favipiravir and nafamostat mesilate in patients with COVID-19 pneumonia

Ikeda, Mahoko; Okugawa, Shu; Kashiwabara, Kosuke; Moritoyo, Takashi; Kanno, Yoshihiro; Jubishi, Daisuke; Hashimoto, Hideki; Okamoto, Koh; Tsushima, Kenji; Uchida, Yasuki; Mitsumura, Takahiro; Igari, Hidetoshi; Tsutsumi, Takeshi; Araoka, Hideki; Yatera, Kazuhiro; Yamamoto, Yoshihiro; Nakamura, Yuki; Otani, Amato; Yamashita, Marie; Wakimoto, Yuji; Shinohara, Takayuki; Adachi‐Katayama, Maho; Oyabu, Tatsunori; Kanematsu, Aoi; Harada, Sohei; Takeshita, Yuichiro; Nakano, Yasutaka; Miyazaki, Yasunari; Sakao, Seiichiro; Saito, Makoto; Ogura, Sho; Yamasaki, Kei; Kawasuji, Hitoshi; Hasegawa, Osamu; Inoue, Jun‐ichiro; Seto, Yasuyuki; Moriya, Kyoji

doi:10.1016/j.ijid.2022.12.039

Cited by 10 publications

(1 citation statement)

References 27 publications

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“…On the side of objective disease status, the prevalence of disease, the number of eligible cases can be reduced suddenly, and unexpectedly, and no more cases can be enrolled, so that the number of finally enrolled cases may even be one‐half or less than half of a calculated sample size. 9 , 10 , 11 , 12 , 13 It is very difficult to judge whether the small sample size trials’ results support the conclusions of the study or not, because for the small sample size trials, in addition to small sample size, there are many other factors that can also influence the final outcomes of a study.…”

Section: What Are the Reasons For Using Small Sample Sizes And How To...mentioning

confidence: 99%

Importance of sample size determination for randomized controlled clinical trials for coronavirus disease 2019 antiviral therapies

Zhaori

2024

Pediatric Investigation

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This commentary focuses on factors related to sample size determination in randomized controlled clinical trials (RCTs) for antiviral therapies against coronavirus disease 2019 (COVID-19) published during the pandemic of COVID-19.The articles involved in the following discussions include a total of 55 original articles on RCTs for antiviral treatments of patients with COVID-19, including the 36 articles mentioned in our previous commentary 1 and 19 original articles added recently based on a search at PubMed and some from other sources. In terms of sample size determination, 33 of 55 (60.0%) RCTs determined their sample size via calculation; in seven (12.7%) of the 55 RCTs the sample size was not determined via calculation; 15 articles did not mention how the sample size was determined. Of the 55 RCT articles, 21 (38.2%) were regarded by the authors or others as having small or too small sample sizes to be able to support the study hypothesis or obtain the expected evidence.These results suggest that considerably high proportions of RCTs authors for antiviral therapies for COVID-19 did not consider sample size determination as an important factor for the success of RCTs, up to 40% of the 55 RCT articles

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Section: What Are the Reasons For Using Small Sample Sizes And How To...mentioning

confidence: 99%

Importance of sample size determination for randomized controlled clinical trials for coronavirus disease 2019 antiviral therapies

Zhaori

2024

Pediatric Investigation

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show abstract

TMPRSS2 inhibitors for the treatment of COVID-19 in adults: a systematic review and meta-analysis of randomized clinical trials of nafamostat and camostat mesylate

Hernández-Mitre,

Morpeth,

Venkatesh

et al. 2024

Clinical Microbiology and Infection

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Antiviral effect and safety of nafamostat mesilate in patients with mild early-onset COVID-19: An exploratory multicentre randomized controlled clinical trial

Okugawa,

Ikeda,

Kashiwabara

et al. 2023

International Journal of Antimicrobial Agents

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Multicenter, single-blind, randomized controlled study of the efficacy and safety of favipiravir and nafamostat mesilate in patients with COVID-19 pneumonia

Cited by 10 publications

References 27 publications

Importance of sample size determination for randomized controlled clinical trials for coronavirus disease 2019 antiviral therapies

Importance of sample size determination for randomized controlled clinical trials for coronavirus disease 2019 antiviral therapies

TMPRSS2 inhibitors for the treatment of COVID-19 in adults: a systematic review and meta-analysis of randomized clinical trials of nafamostat and camostat mesylate

Antiviral effect and safety of nafamostat mesilate in patients with mild early-onset COVID-19: An exploratory multicentre randomized controlled clinical trial

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