The impact of high dose oral cotrimoxazole in patients with COVID-19 with hypoxic respiratory failure requiring non-invasive ventilation: A Case Control Study

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Abstract

Background

COVID-19 can be fatal in a significant proportion of people who develop critical illness, resulting in hypoxic respiratory failure secondary to Acute Respiratory Distress Syndrome (ARDS) which is thought to be mediated by a cytokine storm syndrome. Steroids have been shown to be of some benefit, but the mainstay of treatment remains supportive.

Methods

The data was collected retrospectively from consecutive, newly diagnosed patients presenting to the critical care facility of I Q City Medical College Hospital, Durgapur, India between June and November 2020 with critical COVID-19 on non-invasive ventilation treated with high dose oral cotrimoxazole (CTX) in addition to standard therapy (ST) and compared with patients with critical COVID-19 receiving standard therapy alone.

Results

201 patients were identified. Of which 151 patients received CTX in addition to ST (mean age ± SD 59 ± 13 years, 81% male and mean BMI ± SD 28 ± 2) and 50 patients received ST alone (mean age ± SD 63 ± 12, 64% male and mean BMI ± SD 27 ± 2). We observed that the patients with critical COVID-19 receiving CTX in addition to ST had significantly better outcomes including reduced in-patient mortality (13% versus 40%, p <0.001), length of hospital and critical care unit stay (mean, 11 versus 15 days (p <0.001) and 6 versus 11 days (p <0.001) respectively), and the need for mechanical ventilation (16% versus 42%, p <0.001) with improved CRP at day 7 (mean, 38mg/L versus 62mg/L, p = 0.001).

Conclusion

These results may be due to the antibiotic and anti-cytokine effects of CTX. Clinical trials are currently underway to test our observations.

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  1. SciScore for 10.1101/2021.01.14.21249803: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIACUC: Ethics: Ethical approval was obtained from the IQ City Medical College Hospital Institutional Ethics Committee.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    The statistical software SPSS was used for the analysis.
    SPSS
    suggested: (SPSS, RRID:SCR_002865)

    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: Given that this is a case control study, there may be a potential of selection bias. Despite being a retrospective observational study there was excellent data completeness particularly because the patients were closely monitored in a critical care setting. Use of other investigational drugs as part of ST could have been confounding factors, but due to the significantly large difference in the outcomes and no other investigational drug found to be effective in COVID-19 it is obvious that despite the subtle differences in treatment the impact of co-trimoxazole cannot be overlooked.

    Results from TrialIdentifier: No clinical trial numbers were referenced.


    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.