Annals of medicine
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Letter Randomized Controlled Trial Multicenter Study
Effect of a genetically engineered interferon-alpha versus traditional interferon-alpha in the treatment of moderate-to-severe COVID-19: a randomised clinical trial.
There are few effective therapies for coronavirus disease 2019 (COVID-19) upon the outbreak of the pandemic. To compare the effectiveness of a novel genetically engineered recombinant super-compound interferon (rSIFN-co) with traditional interferon-alpha added to baseline antiviral agents (lopinavir-ritonavir or umifenovir) for the treatment of moderate-to-severe COVID-19. ⋯ rSIFN-co was associated with a shorter time of clinical improvement than traditional interferon-alpha in the treatment of moderate-to-severe COVID-19 when combined with baseline antiviral agents. rSIFN-co therapy alone or combined with other antiviral therapy is worth to be further studied.Key messagesThere are few effective therapies for coronavirus disease 2019 (COVID-19) upon the outbreak of the pandemic. Interferon alphas, by inducing both innate and adaptive immune responses, have shown clinical efficacy in treating severe acute respiratory syndrome coronavirus and Middle East respiratory syndrome coronavirus.In this multicenter, head-to-head, randomized, clinical trial which included 94 participants with moderate-to-severe COVID-19, the rSIFN-co plus antiviral agents (lopinavir-ritonavir or umifenovir) was associated with a shorter time of clinical improvement than interferon-alpha plus antiviral agents.
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Randomized Controlled Trial
A randomized phase-I pharmacokinetic trial comparing the potential biosimilar tocilizumab (QX003S) with the reference product (Actemra®) in Chinese healthy subjects.
QX003S is a biosimilar candidate for the reference tocilizumab, Actemra®. We investigated the tolerance, variability, and pharmacokinetics (PK) of QX003S biosimilar in healthy Chinese male subjects. ⋯ The PK characteristics and immunogenicity exhibited by QX003S were similar to that of the reference product, Actemra®. The safety profile was similar in the two treatment groups with mild-moderate adverse effects.Trial RegistrationThe trial is registered at Chinese Clinical Trial website (http://www.chinadrugtrials.org.cn/index.html#CTR20190002)Key pointsThis was the first clinical report of a new proposed tocilizumab biosimilar, QX003S.This phase-I randomized, controlled study compared pharmacokinetics, variability,immunogenicity, and safety of QX003S vs. the approved tocilizumab product (Actemra@).The results demonstrate bioequivalence between BAT1806 and the reference products (Actemra@), as well as comparable immunogenicity, safety and tolerability profiles.
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Randomized Controlled Trial
Comparative effectiveness of lactulose and sennosides for the prevention of peritoneal dialysis-related peritonitis: an open-label, randomized, active-controlled trial.
To the best of our knowledge, the effectiveness and safety of lactulose in comparison to sennosides, for the prevention of peritoneal dialysis (PD)-related peritonitis, has never been tested in a randomized study. ⋯ Treatment with lactulose is not more effective than sennosides and cannot be routinely recommended for the prevention of peritonitis among the PD population. TRIAL REGISTRATION Thai Clinical Trial Registry (clinicaltrials.in.th); ID: TCTR20171012001 KEY MESSAGE To the best of our knowledge, no randomized controlled trial that compares the efficacy and safety profiles of lactulose versus sennosides for the prevention of PD-related peritonitis among the PD population has been conducted. In this open-label, randomized, active-controlled trial, treatment with lactulose is not more effective than sennosides in the prevention of PD-related peritonitis, and it could increase the risk of bacterial PD-related peritonitis. Further studies with a larger sample size by incorporated real-world evidence are needed to confirm our findings and to explore strategies to prevent peritonitis among PD patients.
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Randomized Controlled Trial Multicenter Study
A randomized, active-controlled, multicentre clinical trial to evaluate the efficacy and safety of oral sitafloxacin versus levofloxacin in Chinese adults with acute uncomplicated or complicated urinary tract infection.
To evaluate the efficacy and safety of oral sitafloxacin versus levofloxacin in Chinese adults with acute uncomplicated urinary tract infection (UTI) or complicated UTI. ⋯ Oral sitafloxacin is as effective and safe as levofloxacin in treating acute uncomplicated and complicated UTI. KEY MESSAGE: Oral sitafloxacin showed similar clinical cure rate and bacterial eradication rate as levofloxacin for treatment of complicated and uncomplicated urinary tract infections (UTIs) in a randomized, active-controlled, multicentre clinical trial. Oral sitafloxacin is safe and well-tolerated in treating acute uncomplicated and complicated UTIs in Chinese adults. Sitafloxacin is a promising alternative treatment option for UTIs in adults.
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Randomized Controlled Trial
Positive-word stimuli via a smartphone application have no immediate-term effects on multi-directional reach ability in standing position: a randomized controlled trial.
The purpose of the study was to examine the immediate-term effect of positive-word stimuli via a smartphone application on the multi-directional reach ability in standing position in young adults. ⋯ Among young adults, positive-word stimuli via a smartphone application did not significantly improve multi-directional reach ability in standing position. These findings do not support the superiority of this intervention among young adults. Trial Registration: Clinicaltrials.gov, NCT03546218. Registered 6 June 2018, https://clinicaltrials.gov/ct2/show/NCT03546218KEY MESSAGESIn our study, among young adults, positive-word stimuli via an SPSRS application did not significantly improve the multi-directional reach ability in the standing position.These findings do not support the superiority of this intervention among young adults.