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J R Soc Med . The difference in all-cause mortality between COVID-19 patients treated with standard of care plus placebo and those treated with standard of care alone ...trial of randomised controlled trials of immunomodulatory kinase inhibitors

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  • J R Soc Med . The difference in all-cause mortality between COVID-19 patients treated with standard of care plus placebo and those treated with standard of care alone ...trial of randomised controlled trials of immunomodulatory kinase inhibitors

    J R Soc Med


    . 2023 Nov 16:1410768231202657.
    doi: 10.1177/01410768231202657. Online ahead of print. The difference in all-cause mortality between COVID-19 patients treated with standard of care plus placebo and those treated with standard of care alone: a network meta-analysis of randomised controlled trials of immunomodulatory kinase inhibitors

    Ping-Tao Tseng 1 2 3 4 , Bing-Syuan Zeng 1 5 , Chih-Wei Hsu 6 , Trevor Thompson 7 , Brendon Stubbs 8 9 10 , Po-Ren Hsueh 11 12 , Kuan-Pin Su 13 14 15 , Yen-Wen Chen 3 , Tien-Yu Chen 16 17 , Yi-Cheng Wu 18 , Pao-Yen Lin 6 19 , Andre F Carvalho 20 , Dian-Jeng Li 21 , Ta-Chuan Yeh 16 , Cheuk-Kwan Sun 22 23 , Yu-Shian Cheng 2 24 , Yow-Ling Shiue 1 4 , Chih-Sung Liang 25 , Yu-Kang Tu 26 27



    AffiliationsAbstract

    Objectives: The aim of this network meta-analysis (NMA) was to assess whether participants assigned to a placebo and standard of care (SoC) group had different major coronavirus disease 2019 (COVID-19)-related outcomes than those assigned to SoC alone.
    Design: Frequentist model-based NMA.
    Setting: We searched for randomised controlled trials (RCTs) of Janus kinase/Bruton tyrosine kinase inhibitors for the management of COVID-19.
    Participants: Patients with COVID-19 infection.
    Main outcome measures: The primary outcome was the 28-day all-cause mortality, and secondary outcomes were: (1) use of mechanical ventilation; (2) secondary bacterial infection; (3) acceptability (i.e. drop-out rate); and (4) safety (i.e. serious adverse events). We conducted an NMA using the frequentist model. Effect sizes were estimated using odds ratios (ORs) with 95% confidence intervals (95% CIs).
    Results: We identified 14 eligible RCTs enrolling a total of 13,568 participants with COVID-19. Participants assigned to placebo plus SoC had a significantly higher risk of 28-day all-cause mortality than those receiving SoC alone (OR = 1.39, 95% CI = 1.07-1.79). This finding did not change substantially by subgroup analysis stratified by epidemiology factor, pandemic history progression and statistical methodologic consideration. In addition, none of the treatments investigated were associated with a significantly different risk of secondary bacterial infection, acceptability or safety compared with the SoC group.
    Conclusions: This NMA suggested a higher all-cause mortality in patients treated with placebo plus SoC compared with those treated with SoC alone. However, caution is advised in interpreting these results due to the absence of a direct head-to-head comparison. Future research should critically evaluate the necessity of placebo administration in COVID-19 RCTs and consider alternative study designs to minimise potential biases.Trial registration: The current study was approved by the Institutional Review Board of the Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan (TSGHIRB No. B-109-29) and registered in PROSPERO (CRD42022376217).

    Keywords: COVID-19; Network meta-analysis; immunomodulatory kinase inhibitor; mortality; placebo.

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