Efficacy and Safety of Lopinavir/Ritonavir or Arbidol in Adult Patients with Mild/Moderate COVID-19: An Exploratory Randomized Controlled Trial

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Abstract

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  1. SciScore for 10.1101/2020.03.19.20038984: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementIRB: Any unexpected medical occurrence resulting in death, prolonged hospitalization, persistent or significant disability or incapacity, which was judged to be causally related to the study intervention, would be reported as a serious adverse event to the Institutional Review Board.
    RandomizationRandomization and masking: All eligible participants were assigned a randomization number which allocated them into one treatment group.
    BlindingThe study was blinded to participants and those physicians and radiologists who reviewed the data and radiological images but open-label to clinicians who recruited patients and research staff.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    No key resources detected.


    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:
    Limitations of study: Our study is not without its limitations. First, we recognize that our sample size was small. Second, the study did not enroll severely or critically ill patients, or patients at increased risk of poor outcome with many comorbidities and was conducted in only one center. Third, the study was not completely blinded, possibly influencing the outcome to some extent. We will continue to follow these patients to evaluate their long-term prognosis. Nevertheless, as a prospective randomized, controlled trial, this study could still provide meaningful suggestions for proper application of LPV/r and arbidol in the treatment of COVID-19. In conclusion, our study found that LPV/r or arbidol monotherapy presents little benefit for improving the clinical outcome of hospitalized patients with mild/moderate COVID-19 beyond symptomatic and supportive care, causing instead more adverse events. Further work is needed to confirm these results.

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT04252885CompletedThe Efficacy of Lopinavir Plus Ritonavir and Arbidol Against…


    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.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.