Background Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective of this study was to assess the benefits of convalescent plasma treatment compared to placebo or no treatment and all-cause mortality in patients with COVID-19, using data from all available randomized clinical trials, including unpublished and ongoing trials (Open Science Framework, https://doi.org/10.17605/OSF.IO/GEHFX). Methods In this collaborative systematic review and meta-analysis, clinical trial registries (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform), the Cochrane COVID-19 register, the LOVE database, and PubMed were searched until April 8, 2021. Investigators of trials registered by March 1, 2021, without published results were contacted via email. Eligible were ongoing, discontinued and completed randomized clinical trials that compared convalescent plasma with placebo or no treatment in COVID-19 patients, regardless of setting or treatment schedule. Aggregated mortality data were extracted from publications or provided by investigators of unpublished trials and combined using the Hartung–Knapp–Sidik–Jonkman random effects model. We investigated the contribution of unpublished trials to the overall evidence. Results A total of 16,477 patients were included in 33 trials (20 unpublished with 3190 patients, 13 published with 13,287 patients). 32 trials enrolled only hospitalized patients (including 3 with only intensive care unit patients). Risk of bias was low for 29/33 trials. Of 8495 patients who received convalescent plasma, 1997 died (23%), and of 7982 control patients, 1952 died (24%). The combined risk ratio for all-cause mortality was 0.97 (95% confidence interval: 0.92; 1.02) with between-study heterogeneity not beyond chance (I2 = 0%). The RECOVERY trial had 69.8% and the unpublished evidence 25.3% of the weight in the meta-analysis. Conclusions Convalescent plasma treatment of patients with COVID-19 did not reduce all-cause mortality. These results provide strong evidence that convalescent plasma treatment for patients with COVID-19 should not be used outside of randomized trials. Evidence synthesis from collaborations among trial investigators can inform both evidence generation and evidence application in patient care.
Objectives Bortezomib vial-sharing is commonly employed to maximize the treatment of patients with multiple myeloma (MM) in resource-limited setting. This strategy minimizes delays in treatment but reduces the dose of bortezomib received by the patient. Herein, we aimed to determine the treatment patterns and outcomes in Filipino patients with MM who received reduced-dose bortezomib. Methods The records of 47 adult patients with MM, seen at our institution from 2016 to 2019 and treated with reduced-dose bortezomib, were retrospectively reviewed. Results The median age of the patients at diagnosis was 55 years; 59.6% were male. VCD (bortezomib, cyclophosphamide, dexamethasone) regimen was the most commonly used (70.7%) bortezomib-based treatment. Among the newly diagnosed patients, bortezomib-based treatment afforded an overall response rate of 79.3%. The median overall survival was not reached. Univariate analysis showed that the hemoglobin level affected response while age, hemoglobin and calcium levels, the choice of induction regimen, and the depth of response all had an impact on survival. Conclusion This study is the first to investigate the real-world outcomes of reduced-dose bortezomib in MM treatment and may provide initial evidence that bortezomib vial-sharing is an acceptable strategy in the treatment of MM in resource-limited setting.
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