Melatonin is significantly associated with survival of intubated COVID-19 patients
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Abstract
Background
Respiratory distress requiring intubation is the most serious complication associated with coronavirus disease 2019 (COVID-19).
Methods
In this retrospective study, we used survival analysis to determine whether or not mortality following intubation was associated with hormone exposure in patients treated at New York Presbyterian/ Columbia University Irving Medical Center. Here, we report the overall hazards ratio for each hormone for exposure before and after intubation for intubated and mechanically ventilated patients.
Results
Among the 189,987 patients, we identified 948 intubation periods across 791 patients who were diagnosed with COVID-19 or infected with SARS-CoV2 and 3,497 intubation periods across 2,981 patients who were not. Melatonin exposure after intubation was statistically associated with a positive outcome in COVID-19 (demographics and comorbidities adjusted HR: 0.131, 95% CI: 7.76E-02 - 0.223, p-value = 8.19E-14) and non-COVID-19 (demographics and comorbidities adjusted HR: 0.278, 95% CI: 0.142 - 0.542, p-value = 1.72E-04) intubated patients. Additionally, melatonin exposure after intubation was statically associated with a positive outcome in COVID-19 patients (demographics and comorbidities adjusted HR: 0.127, 95% CI: 6.01E-02 - 0.269, p-value = 7.15E-08).
Conclusions
Melatonin exposure after intubation is significantly associated with a positive outcome in COVID-19 and non-COVID-19 patients. Additionally, melatonin exposure after intubation is significantly associated with a positive outcome in COVID-19 patients requiring mechanical ventilation. While our models account for many covariates, including clinical history and demographics, it is impossible to rule out confounding or collider biases within our population. Further study into the possible mechanism of this observation is warranted.
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SciScore for 10.1101/2020.10.15.20213546: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: Ethics statement: The study is approved by the Columbia University Irving Medical Center Institutional Review Board (IRB# AAAL0601) and the requirement for an informed consent was waived.
Consent: Ethics statement: The study is approved by the Columbia University Irving Medical Center Institutional Review Board (IRB# AAAL0601) and the requirement for an informed consent was waived.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable For sex, patients identifying their sex as male were identifed as 1, while those who reported their sex as female or other were coded as 0. Table 2: Resources
… SciScore for 10.1101/2020.10.15.20213546: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: Ethics statement: The study is approved by the Columbia University Irving Medical Center Institutional Review Board (IRB# AAAL0601) and the requirement for an informed consent was waived.
Consent: Ethics statement: The study is approved by the Columbia University Irving Medical Center Institutional Review Board (IRB# AAAL0601) and the requirement for an informed consent was waived.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable For sex, patients identifying their sex as male were identifed as 1, while those who reported their sex as female or other were coded as 0. Table 2: Resources
Software and Algorithms Sentences Resources We then mapped RXNorm codes to DrugBank codes and utilized the associated DrugBank categories to identified drugs classified as hormones. RXNormsuggested: (RxNorm, RRID:SCR_006645)DrugBanksuggested: (DrugBank, RRID:SCR_002700)Statistical modeling and software: We used Jupyter Notebooks (jupyter-client version 5.3.4 and jupyter-core version 4.6.1) running Python 3.7 and all fit models using the python lifelines package (version 0.24.4). pythonsuggested: (IPython, RRID:SCR_001658)Results from OddPub: Thank you for sharing your code and data.
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: 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.
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SciScore for 10.1101/2020.10.15.20213546: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Methods Ethics statement The study is approved by the Columbia University Irving Medical Center Institutional Review Board (IRB# AAAL0601) and the requirement for an informed consent was waived. Randomization We conducted a manual chart review of 50 randomly identified intubated COVID-19 patients to identify the justification, if any, for melatonin treatment. Blinding not detected. Power Analysis not detected. Sex as a biological variable For sex, patients identifying their sex as male were identifed as 1, while those who reported their sex as female or other were coded as 0. Table 2: Resources
Software and Algorithms Sentences Resources Statistical modeling and software We … SciScore for 10.1101/2020.10.15.20213546: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Methods Ethics statement The study is approved by the Columbia University Irving Medical Center Institutional Review Board (IRB# AAAL0601) and the requirement for an informed consent was waived. Randomization We conducted a manual chart review of 50 randomly identified intubated COVID-19 patients to identify the justification, if any, for melatonin treatment. Blinding not detected. Power Analysis not detected. Sex as a biological variable For sex, patients identifying their sex as male were identifed as 1, while those who reported their sex as female or other were coded as 0. Table 2: Resources
Software and Algorithms Sentences Resources Statistical modeling and software We used Jupyter Notebooks (jupyter-client version 5.3.4 and jupyter-core version 4.6.1) running Python 3.7 and all fit models using the python lifelines package (version 0.24.4) . Pythonsuggested: (IPython, RRID:SCR_001658)Results from OddPub: Thank you for sharing your code and data.
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: 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.
About SciScore
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