ABSTRACT
Background The severity of coronavirus disease 2019 (COVID-19) infections has led to the development of several therapeutic agents, with tocilizumab becoming increasingly used to treat patients with COVID-19-related pneumonia. Therefore, this study compared the use of tocilizumab treatment with the standard of care (SOC) to determine its efficacy against severe COVID-19-related pneumonia in Japan.Methods This retrospective cohort study was designed to evaluate the efficacy of tocilizumab in two different databases: the JA42434 single-arm study and COVID-19 Registry Japan (COVIREGI-JP) data, with a synthetic control group from the COVIREGI-JP cohort as a benchmark for the tocilizumab group. The study’s primary objective was to evaluate the efficacy of tocilizumab in treating severe COVID-19-related pneumonia compared to the SOC among patients included in the above two databases. The SOC group was extracted as the synthetic control group using exact matching and a propensity score matching in sequence per subject. As a secondary objective, the efficacy of tocilizumab compared to SOC was evaluated exclusively among patients included in the COVIREGI-JP database. In each objective, the primary endpoint was defined as the time to discharge or the status of awaiting discharge.Results For the primary endpoint, the hazard ratio (HR) of the tocilizumab group against the SOC group was 1.070 (95% CI: 0.565 to 2.028). The median time from Study Day 1 to discharge or the state of awaiting discharge was 15 days in the tocilizumab group and 16 days in the SOC group. The HRs for the secondary endpoints, namely, time to improvement in the clinical state, time to clinical failure, and time to recovery, were 1.112 (95% CI: 0.596 to 2.075), 0.628 (95% CI: 0.202 to 1.953), and 1.019 (95% CI: 0.555 to 1.871), respectively. Similarly, the HR of the primary endpoint for the secondary objective was 0.846 (95% CI: 0.582 to 1.230).Conclusions Tocilizumab did not demonstrate a positive effect on time to discharge or the state of awaiting discharge. Furthermore, no statistical differences, such as time to improvement in the clinical state, time to clinical failure, and time to recovery, were observed among the groups in other clinical outcomes.
Subject(s)
COVID-19 , PneumoniaABSTRACT
Objectives Although several randomised controlled trials have compared the efficacy of remdesivir with that of placebo, there is limited evidence regarding its effect in the early stage of nonsevere COVID-19 cases. Methods We evaluated the efficacy of remdesivir on the early stage of nonsevere COVID-19 using the COVID-19 Registry Japan, a nationwide registry of hospitalised COVID-19 patients in Japan. Two regimens (start remdesivir therapy within 4 days from admission vs. no remdesivir during hospitalisation) among patients without the need for supplementary oxygen therapy were compared by a three-step processing (cloning, censoring, and weighting) method. The primary outcome was supplementary oxygen requirement during hospitalisation. Secondary outcomes were 30-day fatality risk and risk of invasive mechanical ventilation or extracorporeal membrane oxygenation (IMV/ECMO). Results The data of 12,657 cases met our inclusion criteria. The ‘start remdesivir’ regimen showed a lower risk of supplementary oxygen requirement (hazard ratio: 0.861, p < 0.001). Both 30-day fatality risk and risk of IMV/ECMO introduction were not significantly different between the two regimens (hazard ratios: 1.05 and 0.886, p values: 0.070 and 0.440, respectively). Conclusions Remdesivir might reduce the risk of oxygen requirement during hospitalisation in the early stage of COVID-19; however, it had no positive effect on the clinical outcome and reduction of IMV/ECMO requirement.
Subject(s)
COVID-19ABSTRACT
Importance: The coronavirus disease 2019 (COVID-19) pandemic may have a negative impact on mental health, leading to higher suicide rates in many countries. However, little is known about the factors associated with worsened mental health during the COVID-19 pandemic. Objective: To investigate the factors associated with serious psychological distress (SPD) during the COVID-19 pandemic in Japan. Design, Setting, and Participants: A cross-sectional study using a large-scale internet survey conducted between August 25 and September 30, 2020, in Japan. Exposures: Demographics (age, gender, marital status, family composition, and caregiving burden), socio-economic status (income level, employment type, educational attainment); the experience of domestic violence (DV), the state of emergency, fear of COVID-19, and stigma related to COVID-19. Main Outcomes and Measures: Prevalence of SPD, defined as Kessler 6 scale score [≥]13. Results: Among 25,482 individuals included in this study, 2,556 (10%) met the criteria of SPD. Overall, women (adjusted odds ratio [aOR] 1.59; 95%CI, 1.17-2.16; P=0.003), ages 15-29 (aOR compared with ages 45-59, 2.35; 95%CI, 1.64-3.38; P<0.001), low income (aOR compared with intermediate income, 1.70; 95%CI, 1.16-2.49; P=0.007), those who provide caregiving to family members (aOR, 5.48; 95%CI, 3.51-8.56; P<0.001), experiencing DV (aOR, 5.72; 95%CI, 3.81-8.59; P<0.001), and fear of COVID-19 (aOR, 1.96; 95%CI, 1.55-2.48; P<0.001) were associated with a higher prevalence of SPD. Among women aged 15-29 years who experienced the highest rate of SPD, caregiving, DV, fear of COVID-19, and COVID-19-related stigma were associated with a higher likelihood of SPD; whereas economic situation (income level and employment type) and social isolation (marital status) were not associated with the prevalence of SPD. Conclusions and Relevance: Economic situation, caregiving burden, DV, and fear of COVID-19 were independently associated with SPD during the COVID-19 pandemic. Among young women--who have a higher risk of suicide during the COVID-19 pandemic in Japan--similar factors, except economic situation, were associated with a higher rate of SPD. Targeted interventions based on age and gender may be more effective in mitigating the negative impact of the COVID-19 pandemic on the population's mental health.