A simple, home-therapy algorithm to prevent hospitalisation for COVID-19 patients: A retrospective observational matched-cohort study

  1. Fredy Suter
  2. Elena Consolaro
  3. Stefania Pedroni
  4. Chiara Moroni
  5. Elena Pastò
  6. Maria Vittoria Paganini
  7. Grazia Pravettoni
  8. Umberto Cantarelli
  9. Nadia Rubis
  10. Norberto Perico
  11. Annalisa Perna
  12. Tobia Peracchi
  13. Piero Ruggenenti
  14. Giuseppe Remuzzi

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Abstract

No abstract available

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  1. Version published to 10.1016/j.eclinm.2021.100941
  2. ScreenIT

    SciScore for 10.1101/2021.03.25.21254296: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: The doctors were asked to fill an online questionnaire after collection of the consent form signed by the patients.
    IACUC: The COVER study has been approved by the Centralised Ethical Committee for all COVID-19 trials in Italy based at the Istituto Nazionale per le Malattie
    Randomizationnot detected.
    Blindingnot detected.
    Power AnalysisWith the above assumptions a sample size of 86 per group (172 total) would achieve 90% power to reject the null hypothesis of equal means when the population mean difference is μ1 - μ2 = 20 - 15 = 5 days with a standard deviation for both groups of 10 days and with a significance level (alpha) of 0.05 using a two-sided two-sample equal-variance t-test.
    Sex as a biological variablePatients were eligible if male and female adults (> 18 years old), with early mild symptoms of COVID-19, who started the recommended treatment, without waiting results of a nasopharyngeal swab, if any.

    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:
    The results is even more surprising considering that controls presented with symptoms during the first epidemic wave when the health care system was pushed to its limit and not all patients in need might have access to the hospital because of strong limitations of available resources. Thus, lower hospitalization rate of patients given at home-therapy according to guidelines was not an issue of reduced hospital access. The pillars of the proposed treatment recommendation 10 are three-fold: i) intervene at the very onset of mild/moderate symptoms at home; ii) start treatment as early as possible after the family doctor has been called by the patient without waiting the results of a nasopharyngeal swab; iii) rely on particular non-steroidal anti-inflammatory drugs, unless contraindicated. Indeed, after the initial exposure to SARS-CoV-2, patients typically develop symptoms that underline an inflammatory process within 5 to 6 days on average .23 Insights into the pathogenic mechanism underlying SARS-CoV-2 infection highlight the critical role of inflammatory hyper-response, characterised by tissue leucocyte infiltration, macrophage activation, widespread endothelial damage, complement–induced blood clotting and systemic microangiopathy, in disease progression.24 Accumulating evidence suggests that this hyper-inflammatory reaction, rather than the virus itself, underpins the progression to severe COVID-19 cases, and pro-inflammatory cytokines and macrophages seem to be integral to...

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

    IdentifierStatusTitle
    NCT04799834RecruitingGenotype and Susceptibility to COVID-19
    NCT04794998RecruitingA Simple Approach to Treat COVID-19 Patients at Home.

    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.

  3. Version published to 10.1101/2021.03.25.21254296 on medRxiv