Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab
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SciScore for 10.1101/2021.05.27.21257096: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: All patients provided written informed consent. Sex as a biological variable not detected. Randomization Trial Objectives and Oversight: This phase 3, randomized, double-blind, multicenter, placebo-controlled study is evaluating a single intravenous infusion of sotrovimab 500 mg for the prevention of progression of mild/moderate Covid-19 in high-risk, nonhospitalized patients. Blinding not detected. Power Analysis Sample size calculations were based on a group sequential design with two interim analyses to assess both futility due to lack of efficacy or profound efficacy. Table 2: Resources
Antibodies Sentences Resources Safety Assessments: Safety endpoints included adverse events, serious … SciScore for 10.1101/2021.05.27.21257096: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: All patients provided written informed consent. Sex as a biological variable not detected. Randomization Trial Objectives and Oversight: This phase 3, randomized, double-blind, multicenter, placebo-controlled study is evaluating a single intravenous infusion of sotrovimab 500 mg for the prevention of progression of mild/moderate Covid-19 in high-risk, nonhospitalized patients. Blinding not detected. Power Analysis Sample size calculations were based on a group sequential design with two interim analyses to assess both futility due to lack of efficacy or profound efficacy. Table 2: Resources
Antibodies Sentences Resources Safety Assessments: Safety endpoints included adverse events, serious adverse events, and adverse events of special interest, defined as infusion-related reactions (including hypersensitivity reactions), immunogenicity testing for anti-drug antibodies, and evaluation of antibody-dependent enhancement. anti-drugsuggested: Noneantibody-dependent enhancement.suggested: NoneResults 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:This interim report has three major limitations. First, with only three hospitalizations in the sotrovimab group, it is not possible to determine which patient or disease characteristics might be associated with sotrovimab treatment failure. Second, the safety dataset was moderate in size (430 patients) and thus a rare (much less than 1%) adverse event may not have been observed, though one would not be expected as sotrovimab was derived from an antibody isolated from a recovered SARS-CoV patient, has minimal engineering, and targets a viral epitope (not a host epitope). Third, secondary and exploratory endpoint analyses are excluded from this interim report since the study is ongoing; such analyses are needed to further determine the potential additional benefits of sotrovimab. This study has two key scientific and medical ramifications, beyond demonstrating the therapeutic value of sotrovimab. First, the results indicate that a non–receptor-binding motif binding antibody, which does not directly block the ACE2 receptor interaction, can be clinically therapeutic, and suggests a role for other receptors.27 Second, as sotrovimab has potent effector function, the absence of safety signals and profound efficacy strongly suggest that effector function is neither detrimental nor associated with antibody-dependent enhancement.26 In fact, preclinical models of Covid-19 suggest that its potent effector function may be beneficial.13,14 In conclusion, results from this interim analysis...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04545060 Active, not recruiting VIR-7831 for the Early Treatment of COVID-19 in Outpatients 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.
Results from scite Reference Check: We found no unreliable references.
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