Effectiveness of remdesivir in hospitalized nonsevere patients with COVID-19 in Japan: A large observational study using the COVID-19 Registry Japan

Tsuzuki, Shinya; Hayakawa, Kayoko; Uemura, Yukari; Shinozaki, Tomohiro; Matsunaga, Nobuaki; Terada, Mari; Suzuki, Setsuko; Asai, Yasufumi; Kitajima, Koji; Saito, Sho; Yamada, Gen; Shibata, Taro; Kondo, Masashi; Izumi, Kazuo; Hojo, Masayuki; Mizoue, Tetsuya; Yokota, Kazuhisa; Nakamura‐Uchiyama, Fukumi; Saito, Fumitake; Sugiura, Wataru; Ohmagari, Norio

doi:10.1016/j.ijid.2022.02.039

Cited by 11 publications

(9 citation statements)

References 19 publications

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“…In the current study, more than half of the Omicron-infected patients received RDV therapy within 3 days of the onset of symptoms, compared to nearly 28% in the Delta wave, and initiation of therapy within the first 5 days was documented in 87% and 57% of patients, respectively. Early drug administration has an impact on its effectiveness, and has been documented in clinical trials and numerous RWE analyses [ 22 , 48 , 52 , 58 , 59 ]. According to national recommendations, the optimal time to start RDV therapy is within the first 5 days; however, data from clinical trials have indicated the effectiveness of treatment starting up to 10 days from the onset of symptoms [ 22 , 32 ].…”

Section: Discussionmentioning

confidence: 99%

Retrospective Analysis of the Effectiveness of Remdesivir in COVID-19 Treatment during Periods Dominated by Delta and Omicron SARS-CoV-2 Variants in Clinical Settings

Dobrowolska

Zarębska-Michaluk

Brzdęk

et al. 2023

JCM

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Continuous evaluation of real-world treatment effectiveness of COVID-19 medicines is required due to the ongoing evolution of SARS-CoV-2 and the possible emergence of resistance. Therefore, this study aimed to analyze, in a retrospective manner, the outcomes in patients hospitalized with COVID-19 during the pandemic waves dominated by Delta and Omicron variants and treated with remdesivir (RDV) (n = 762) in comparison to a demographically and clinically matched group not treated with any antivirals (n = 1060). A logistic regression analysis revealed that RDV treatment was associated with a significantly lower risk of death during both Delta wave (OR = 0.42, 95%CI: 0.29–0.60; p < 0.0001) and Omicron-dominated period (OR = 0.56, 95%CI: 0.35–0.92; p = 0.02). Moreover, RDV-treated groups were characterized by a lower percentage of patients requiring mechanical ventilation, but the difference was not statistically significant. This study is the first real-world evidence that RDV remains effective during the dominance of more pathogenic SARS-CoV-2 variants and those that cause a milder course of the disease, and continues to be an essential element of COVID-19 therapy.

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Section: Discussionmentioning

confidence: 99%

Retrospective Analysis of the Effectiveness of Remdesivir in COVID-19 Treatment during Periods Dominated by Delta and Omicron SARS-CoV-2 Variants in Clinical Settings

Dobrowolska

Zarębska-Michaluk

Brzdęk

et al. 2023

JCM

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show abstract

“…Early drug administration has an impact on its effectiveness, which has been documented in clinical trials and numerous RWE analyses 27,37,41,47,48 . According to national recommendations, the optimal time to start RDV therapy is the first 5 days; however, data from clinical trials indicate the effectiveness of treatment started up to 10 days from the onset of symptoms 20,27 .…”

Section: Discussionmentioning

confidence: 99%

Clinical evidence of the effectiveness of remdesivir in COVID-19 during periods dominated by Delta and Omicron SARS-CoV-2 variants.

Zarębska-Michaluk

Dobrowolska

Brzdęk

et al. 2023

Preprint

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Continuous evaluation of real-world treatment effectiveness of COVID-19 medicines is required due to the ongoing evolution of SARS-CoV-2 and the possible emergence of resistance. Therefore, this study aimed to analyze the outcomes in patients hospitalized with COVID-19 during the pandemic waves dominated by Delta and Omicron variants and treated with remdesivir (RDV) (n=762) in comparison to the demographically and clinically matched group not treated with any antivirals (n=1060). During the Delta wave, the RDV-treated group revealed 2-fold lower mortality (10.8 vs. 23.2%, p<0.001) and 1.5-fold lower during the Omicron-dominated period (11.4 vs. 16.8%, p=0.05). RDV-treated groups were characterized by a lower percentage of patients requiring mechanical ventilation, but the difference was not statistically significant. This study is the first real-world evidence that RDV remains effective during the dominance of more pathogenic SARS-CoV-2 variants and those that cause a milder course of the disease and continues to be an essential element of COVID-19 therapy.

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“…This design framework can be applied to mimic a hypothetical trial or contribute to existing knowledge, especially when data from randomised controlled trials are unavailable [ 17 ]. During the COVID-19 pandemic, this framework was used in a wide range of evaluations, i.e., drug therapies [ 18 , 19 , 20 , 21 , 22 , 23 , 24 ], extracorporeal membrane oxygenation [ 25 , 26 ], vaccine effectiveness [ 27 , 28 ], non-pharmaceutical interventions, and policy evaluations [ 29 ]. To emulate a trial, there are two common methods: the cloning approach and the sequential trial approach [ 17 , 30 ].…”

Section: Introductionmentioning

confidence: 99%

Target Trial Emulation Using Hospital-Based Observational Data: Demonstration and Application in COVID-19

Martinuka

Cube

Hazard

et al. 2023

Life

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Methodological biases are common in observational studies evaluating treatment effectiveness. The objective of this study is to emulate a target trial in a competing risks setting using hospital-based observational data. We extend established methodology accounting for immortal time bias and time-fixed confounding biases to a setting where no survival information beyond hospital discharge is available: a condition common to coronavirus disease 2019 (COVID-19) research data. This exemplary study includes a cohort of 618 hospitalized patients with COVID-19. We describe methodological opportunities and challenges that cannot be overcome applying traditional statistical methods. We demonstrate the practical implementation of this trial emulation approach via clone–censor–weight techniques. We undertake a competing risk analysis, reporting the cause-specific cumulative hazards and cumulative incidence probabilities. Our analysis demonstrates that a target trial emulation framework can be extended to account for competing risks in COVID-19 hospital studies. In our analysis, we avoid immortal time bias, time-fixed confounding bias, and competing risks bias simultaneously. Choosing the length of the grace period is justified from a clinical perspective and has an important advantage in ensuring reliable results. This extended trial emulation with the competing risk analysis enables an unbiased estimation of treatment effects, along with the ability to interpret the effectiveness of treatment on all clinically important outcomes.

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Effectiveness of remdesivir in hospitalized nonsevere patients with COVID-19 in Japan: A large observational study using the COVID-19 Registry Japan

Cited by 11 publications

References 19 publications

Retrospective Analysis of the Effectiveness of Remdesivir in COVID-19 Treatment during Periods Dominated by Delta and Omicron SARS-CoV-2 Variants in Clinical Settings

Retrospective Analysis of the Effectiveness of Remdesivir in COVID-19 Treatment during Periods Dominated by Delta and Omicron SARS-CoV-2 Variants in Clinical Settings

Clinical evidence of the effectiveness of remdesivir in COVID-19 during periods dominated by Delta and Omicron SARS-CoV-2 variants.

Target Trial Emulation Using Hospital-Based Observational Data: Demonstration and Application in COVID-19

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