Early COVID-19 therapy with azithromycin plus nitazoxanide, ivermectin or hydroxychloroquine in outpatient settings significantly improved COVID-19 outcomes compared to known outcomes in untreated patients

  1. F.A. Cadegiani
  2. A. Goren
  3. C.G. Wambier
  4. J. McCoy

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  1. Version published to 10.1016/j.nmni.2021.100915
  2. ScreenIT

    SciScore for 10.1101/2020.10.31.20223883: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: Patients that fulfilled criteria for the observational study consented in a formal written manner exactly as determined by the Institutional Review Board (IRB) of the Ethics Committee of the National Board of Ethics Committee of the Ministry of Health, Brazil (CEP/CONEP: Parecer 4.173.074 / CAAE: 34110420.2.0000.0008).
    RandomizationControl Group 1 (CG1) is a group of paired untreated patients randomly obtained retrospectively from the population of the same community that had confirmed diagnosis of COVID-19 during the same period of those included in the Pre-AndroCoV Trial. i.e., that presented COVID-19 alongside patients included in the present observational study, that either refused or were not offered a treatment with any drug between nitazoxanide, hydroxychloroquine and ivermectin.
    Blindingnot detected.
    Power AnalysisSample size was determined based on the assumptions thatits estimate for the chi-squared test would require 80% power to detect the difference in proportions at p = 0.05, at least 95% of subjects would complete the study, and hospitalization and death rates being between 3 and 20%, and 0.3 and 2.5%, respectively.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    A second control group (Control Group 2 - CG2) resulted from a precise estimation based on a thorough and structured review of articles indexed in PubMed and MEDLINE, and statements by official government agencies and specific medical societies (50-84).
    PubMed
    suggested: (PubMed, RRID:SCR_004846)
    MEDLINE
    suggested: (MEDLINE, RRID:SCR_002185)
    Parameters: Major clinical course, outcomes and endpoints were measured or calculated for all groups, including viral shedding using rtPCR-SARS-CoV-2 (Abbott RealTime SARS-CoV-2 Assay, Abbott, USA; or Cobas SARS-CoV-2, Roche, Switzerland), remission of symptoms related to acute COVID-19 not including and including anosmia and ageusia, percentage of hospitalization, mechanical ventilation and deaths, and presence of mental or physical post-COVID symptoms.
    Abbott
    suggested: (Abbott, RRID:SCR_010477)
    All statistical tests were performed using XLSTAT version 22.4.1 (
    XLSTAT
    suggested: (XLSTAT, RRID:SCR_016299)

    Results from OddPub: Thank you for sharing your data.

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Despite the limitations for a precise characterization of early COVID-19, associated with the fact that for ethical reasons differences were underestimated, the present comparative analysis revealed differences unlikely to be random for the most relevant clinical outcomes, with potential ability to prevent a non-negligible number of hospitalizations, mechanical ventilations, and deaths. The analysis disclosed approximate reductions of one third in viral shedding, two thirds in clinical duration, and 100% prevention of hospitalization, mechanical ventilation, and deaths, when compared to both CG-1 and CG-2, together and separately, which were shown to represent substantial and possibly conclusive improvements regarding the benefits, when using one of the three pharmacological interventions in early stage COVID-19, at least in when combined with azithromycin, and in majority of the cases, zinc, vitamin C and vitamin D. Since the median age was below 60 y/o and the prevalence of less than 20% and 30% of obesity and comorbidities, respectively, and COVID-19 related complications are highly correlated with risk factors, in an exponential manner with aging, the ability to detect differences in lower risk populations allow us hypothesize that in higher-risk groups of patients infected by COVID-19 would potentially lead to more substantial differences due to the larger number of complication events, allowing more visible distinctions between groups, although this is yet to be determi...

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

    IdentifierStatusTitle
    NCT04446429CompletedAnti-Androgen Treatment for COVID-19

    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

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  3. Version published to 10.1101/2020.10.31.20223883v1 on medRxiv