A cohort study of 223 patients explores the clinical risk factors for the severity diagnosis of COVID-19

  1. Yongsheng Huang
  2. Xiaoyu Lyu
  3. Dan Li
  4. Yujun Wang
  5. Lin Wang
  6. Wenbin Zou
  7. Yingxin Wei
  8. Xiaowei Wu

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Abstract

BACKGROUND

Coronavirus Disease 2019 (COVID-19) has recently become a public emergency and a worldwide pandemic. The clinical symptoms of severe and non-severe patients vary, and the case-fatality rate (CFR) in severe COVID-19 patients is very high. However, the information on the risk factors associated with the severity of COVID-19 and of their prognostic potential is limited.

METHODS

In this retrospective study, the clinical characteristics, laboratory findings, treatment and outcome data were collected and analyzed from 223 COVID-19 patients stratified into 125 non-severe patients and 98 severe patients. In addition, a pooled large-scale meta-analysis of 1646 cases was performed.

RESULTS

We found that the age, gender and comorbidities are the common risk factors associated with the severity of COVID-19. For the diagnosis markers, we found that the levels of D-dimer, C-reactive protein (CRP), lactate dehydrogenase (LDH), procalcitonin (PCT) were significantly higher in severe group compared with the non-severe group on admission (D-Dimer: 87.3% vs. 35.3%, P <0.001; CRP, 65.1% vs. 13.5%, P <0.001; LDH: 83.9% vs. 22.2%, P <0.001; PCT: 35.1% vs. 2.2%, P <0.001), while the levels of aspartate aminotransferase (ASP) and creatinine kinase (CK) were only mildly increased. We also made a large scale meta-analysis of 1646 cases combined with 4 related literatures, and further confirmed the relationship between the COVID-19 severity and these risk factors. Moreover, we tracked dynamic changes during the process of COVID-19, and found CRP, D-dimer, LDH, PCT kept in high levels in severe patient. Among all these markers, D-dimer increased remarkably in severe patients and mostly related with the case-fatality rate (CFR). We found adjuvant antithrombotic treatment in some severe patients achieved good therapeutic effect in the cohort.

CONCLUSIONS

The diagnosis markers CRP, D-dimer, LDH and PCT are associated with severity of COVID-19. Among these markers, D-dimer is sensitive for both severity and CFR of COVID-19. Treatment with heparin or other anticoagulants may be beneficial for COVID-19 patients.

Funding

This study was supported by funding from the National Key Research and Development Program of China (2016YFC1302203); Beijing Nova Program (grant number: xx2018040).

Role of the funding source

The funding listed above supports this study, but had no role in the design and conduct of the study.

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  1. ScreenIT

    SciScore for 10.1101/2020.04.18.20070656: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: The ethics committee of Wuhan Tongji Hospital and Central Hospital of Wuhan appoved this study and granted a waiver of informed consent in light of the urgent need to collect clinical data.
    Consent: The ethics committee of Wuhan Tongji Hospital and Central Hospital of Wuhan appoved this study and granted a waiver of informed consent in light of the urgent need to collect clinical data.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Statistical analyses were done using the Statistical Package for the Social Sciences (SPSS) software (version 21.0).
    Statistical Package for the Social Sciences
    suggested: (SPSS, RRID:SCR_002865)
    SPSS
    suggested: (SPSS, RRID:SCR_002865)
    Meta-analysis: In meta-analysis, we first carried out a computerized literature search of the PubMed, Web of Science, EBSCO and CNKI database (prior to March 15th, 2020) using the following words and terms: ‘‘COVID-19’’, ‘‘SARS-COV-2’’.
    PubMed
    suggested: (PubMed, RRID:SCR_004846)

    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:
    Our study still has several limitations. Firstly, it is reported that some patients with positive chest CT findings may have negative RT-PCR results. In that case, there may be selection bias since only the positive cases confirmed by the RT-PCR were included in our study. Secondly, although we want to track the timeline of each patient’s blood test and other clinical tests, but we did not collect all the data of some patients at each time point for various reasons. This may result in a large standard error of the time axis. In summary, our study showed CRP, D-dimer, LDH, PCT are the high risk factors related with COVID-19. Especially, D-dimer is a critical indicator for both severity and CFR of COVID-19. As high CFR in the severe COVID-19 patients need to be resolved immediately, the risk factors explored in our study are important of taking into account the disease severity in practice. Though the prognostic factors in our study still need to be further validated by future studies, they should be helpful to provide warning model for predicting severity and mortality in COVID-19, which is very useful for clinical application.

    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.

  2. Version published to 10.1101/2020.04.18.20070656v1 on medRxiv