Nitric oxide gas inhalation to prevent COVID-2019 in healthcare providers

  1. Stefano Gianni
  2. Bijan Safaee Fakhr
  3. Caio Cesar Araujo Morais
  4. Raffaele Di Fenza
  5. Grant Larson
  6. Riccardo Pinciroli
  7. Timothy Houle
  8. Ariel Louise Mueller
  9. Andrea Bellavia
  10. Robert Kacmarek
  11. Ryan Carroll
  12. Lorenzo Berra

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Abstract

Introduction

In human hosts, SARS-CoV-2 causes a respiratory syndrome (named COVID-19) which can range from a mild involvement of the upper airways to a severe pneumonia with acute respiratory syndrome that requires mechanical ventilation in an intensive care unit (ICU). Hospital-associated transmission is an important route of spreading for the SARS-CoV-2 virus and healthcare providers are at the highest risk. As of February 2020, 1716, Chinese healthcare workers had confirmed SARS-CoV-2 infections and at least 6 died. Unfortunately, there is currently no vaccine or pharmacological prophylaxis to decrease the risk of healthcare providers contracting the infection.

Methods and analysis

We will randomize 470 healthcare providers scheduled to work with COVID 19 patients to receive nitric oxide gas administration (NO group, n=235) or no gas administration (control group, n=235). The primary endpoint of this study is the incidence of subjects with COVID-19 disease at 14 days from enrollment. Secondary endpoints are the proportion of healthcare providers who present a positive real time RT-PCR test for SARS-CoV- 2 14 days after enrollment, the proportion of healthcare providers requiring quarantine, and the total number of quarantine days in the two groups.

Ethics and dissemination

The trial protocol is under the approval of The Partners Human Research Committee of Massachusetts General Hospital (Boston, USA) and recruitment is expected to start in April 2020. The results of this study will be published in scientific journals and presented at scientific meetings.

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  1. ScreenIT

    SciScore for 10.1101/2020.04.05.20054544: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: The signed informed consent will be kept in a secure place for at least 5 years after study completion.
    RandomizationStudy setting: This is a single center, randomized (1:1) controlled, parallel-arm clinical trial.
    Blindingnot detected.
    Power AnalysisConsidering an alpha level of 0.05 and a power of 0.9, we determined a sample size of n1=207, n2=207, by a two-sided test.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Assignment of interventions: Randomization will occur through a random allocation sequence generated by a computerized random generation program (REDCap).
    REDCap
    suggested: (REDCap, RRID:SCR_003445)

    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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

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

    IdentifierStatusTitle
    NCT04312243Active, not recruitingNO Prevention of COVID-19 for Healthcare Providers

    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.

  2. Version published to 10.1101/2020.04.05.20054544 on medRxiv