A two-arm, randomized, controlled, multi-centric, open-label phase-2 study to evaluate the efficacy and safety of Itolizumab in moderate to severe ARDS patients due to COVID-19
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SciScore for 10.1101/2020.12.01.20239574: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Subjects provided written informed consent prior to initiation of the study procedures. Randomization Study design: This was an open-label, two-arm, randomized, controlled, multi-centric, phase-2 study conducted in 4 designated COVID-19 hospitals in India. Blinding not detected. Power Analysis not detected. Sex as a biological variable Study subjects: Adult male or female patients above 18 years, who tested positive for virologic diagnosis of SARS-CoV-2 infection (RT-PCR), and who were hospitalized due to clinical worsening with oxygen saturation of ≤94% at rest in ambient air, were eligible for randomization if they had either moderate to severe ARDS or high … SciScore for 10.1101/2020.12.01.20239574: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Subjects provided written informed consent prior to initiation of the study procedures. Randomization Study design: This was an open-label, two-arm, randomized, controlled, multi-centric, phase-2 study conducted in 4 designated COVID-19 hospitals in India. Blinding not detected. Power Analysis not detected. Sex as a biological variable Study subjects: Adult male or female patients above 18 years, who tested positive for virologic diagnosis of SARS-CoV-2 infection (RT-PCR), and who were hospitalized due to clinical worsening with oxygen saturation of ≤94% at rest in ambient air, were eligible for randomization if they had either moderate to severe ARDS or high levels of proinflammatory markers. Table 2: Resources
Antibodies Sentences Resources Major exclusion criteria included - known severe allergic reactions to monoclonal antibodies, an active tuberculosis (TB) infection/inadequately treated tuberculosis/latent tuberculosis, on oral anti-rejection or any immune-suppressive drugs in last 6 months, those who participated in other drug clinical trials using anti-IL-6 therapy. anti-rejectionsuggested: Noneanti-IL-6suggested: NoneSoftware and Algorithms Sentences Resources All statistical analysis was performed using SAS® (version 9.4) software. SAS®suggested: (SASqPCR, RRID:SCR_003056)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:We identified a mortality benefit in the current study and interpret this cautiously considering the small sample size and usual limitations of undertaking an open label study, which has been conducted within the restrictions imposed by an ongoing pandemic [33]. We further acknowledge that the open-label design is also known to yield slightly larger estimates of effect size, to ameliorate which blinded, large clinical trials need to be conducted [34]. However, what is encouraging is that in addition to the mortality benefit, the current effort also identified favorable outcomes related to improved lung functions, biomarker profile and clinical resolution, especially with respect to respiratory/ventilatory support requirements. This constellation of clinical and laboratory findings supporting the beneficial effect of Itolizumab, which are likely to be internally valid for the given patient set, warrants deeper investigation to ensure generalizability and external validity of the results. The recent emergency use authorization accorded to Itolizumab for use in COVID-19 patients in India and Cuba, provides a window of opportunity to conduct a larger, global, phase 3 study and undertake post-marketing surveillance to explore the utility and impact of Itolizumab in COVID-19 cases with cytokine release syndrome. The role of systemic vasculitis and cytokine mediated coagulation disorders have been recognized as significant factors for multi organ failure in patients with severe COVI...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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