Zinc sulfate in combination with a zinc ionophore may improve outcomes in hospitalized COVID-19 patients
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Abstract
Introduction. COVID-19 has rapidly emerged as a pandemic infection that has caused significant mortality and economic losses. Potential therapies and prophylaxis against COVID-19 are urgently needed to combat this novel infection. As a result of in vitro evidence suggesting zinc sulphate may be efficacious against COVID-19, our hospitals began using zinc sulphate as add-on therapy to hydroxychloroquine and azithromycin.
Aim. To compare outcomes among hospitalized COVID-19 patients ordered to receive hydroxychloroquine and azithromycin plus zinc sulphate versus hydroxychloroquine and azithromycin alone.
Methodology. This was a retrospective observational study. Data was collected from medical records for all patients with admission dates ranging from 2 March 2020 through to 11 April 2020. Initial clinical characteristics on presentation, medications given during the hospitalization, and hospital outcomes were recorded. The study included patients admitted to any of four acute care NYU Langone Health Hospitals in New York City. Patients included were admitted to the hospital with at least one positive COVID-19 test and had completed their hospitalization. Patients were excluded from the study if they were never admitted to the hospital or if there was an order for other investigational therapies for COVID-19.
Results. Patients taking zinc sulphate in addition to hydroxychloroquine and azithromycin ( n =411) and patients taking hydroxychloroquine and azithromycin alone ( n =521) did not differ in age, race, sex, tobacco use or relevant comorbidities. The addition of zinc sulphate did not impact the length of hospitalization, duration of ventilation or intensive care unit (ICU) duration. In univariate analyses, zinc sulphate increased the frequency of patients being discharged home, and decreased the need for ventilation, admission to the ICU and mortality or transfer to hospice for patients who were never admitted to the ICU. After adjusting for the time at which zinc sulphate was added to our protocol, an increased frequency of being discharged home (OR 1.53, 95 % CI 1.12–2.09) and reduction in mortality or transfer to hospice among patients who did not require ICU level of care remained significant (OR 0.449, 95 % CI 0.271–0.744).
Conclusion. This study provides the first in vivo evidence that zinc sulphate may play a role in therapeutic management for COVID-19.
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SciScore for 10.1101/2020.05.02.20080036: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: Study approval: The study was approved by the NYU Grossman School of Medicine Institutional Review Board.
Consent: A waiver of informed consent and a waiver of the Health Information Portability Privacy act were granted.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources All analyses were performed using STATA/SE 16.0 software (STATA Corp.). STATA/SEsuggested: NoneResults 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 Li…SciScore for 10.1101/2020.05.02.20080036: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: Study approval: The study was approved by the NYU Grossman School of Medicine Institutional Review Board.
Consent: A waiver of informed consent and a waiver of the Health Information Portability Privacy act were granted.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources All analyses were performed using STATA/SE 16.0 software (STATA Corp.). STATA/SEsuggested: NoneResults 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:This study has several limitations. First, this was an observational retrospective analysis that could be impacted by confounding variables. This is well demonstrated by the analyses adjusting for the difference in timing between the patients who did not receive zinc and those who did. In addition, we only looked at patients taking hydroxychloroquine and azithromycin. We do not know whether the observed added benefit of zinc sulfate to hydroxychloroquine and azithromycin on mortality would have been seen in patients who took zinc sulfate alone or in combination with just one of those medications. We also do not have data on the time at which the patients included in the study initiated therapy with hydroxychloroquine, azithromycin, and zinc. Those drugs would have been started at the same time as a combination therapy, but the point in clinical disease at which patients received those medications could have differed between our two groups. Finally, the cohorts were identified based on medications ordered rather than confirmed administration, which may bias findings towards favoring equipoise between the two groups. In light of these limitations, this study should not be used to guide clinical practice. Rather, our observations support the initiation of future randomized clinical trials investigating zinc sulfate against COVID-19.
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 10.1101/2020.05.02.20080036: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Study approval The study was approved by the NYU Grossman School of Medicine Institutional Review Board. Randomization Rather, our observations support the initiation of future randomized clinical trials investigating zinc sulfate against COVID-19. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources All analyses were performed using STATA/SE 16.0 software (STATA Corp.). STATA/SEsuggested: NoneResults from OddPub: We did not find a statement about open data. We also did not find a statement about …
SciScore for 10.1101/2020.05.02.20080036: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Study approval The study was approved by the NYU Grossman School of Medicine Institutional Review Board. Randomization Rather, our observations support the initiation of future randomized clinical trials investigating zinc sulfate against COVID-19. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources All analyses were performed using STATA/SE 16.0 software (STATA Corp.). STATA/SEsuggested: NoneResults from OddPub: We did not find a statement about open data. We also did not find a statement about open code. Researchers are encouraged to share open data when possible (see Nature blog).
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 is not a substitute for expert review. SciScore checks for the presence and correctness of RRIDs (research resource identifiers) in the manuscript, and detects sentences that appear to be missing RRIDs. SciScore also checks to make sure that rigor criteria are addressed by authors. It does this by detecting sentences that discuss criteria such as blinding or power analysis. SciScore does not guarantee that the rigor criteria that it detects are appropriate for the particular study. Instead it assists authors, editors, and reviewers by drawing attention to sections of the manuscript that contain or should contain various rigor criteria and key resources. For details on the results shown here, including references cited, please follow this link.
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