Features and outcomes of secondary sepsis and urinary tract infections in COVID-19 patients treated with stem cell nebulization

  1. Gina M. Torres Zambrano
  2. Rene Antonio Rivero
  3. Carlos A. Villegas Valverde
  4. Yendry Ventura Carmenate

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Abstract

Background

COVID-19 is the defining global crisis of our time. Secondary complication such as urinary tract infections and sepsis, worsen the already established problem, creating a new challenge.

Objective

To characterize the features and outcomes in COVID-19 patients with sepsis and urinary tract infection.

Methods

An observational and analytical study was conducted within the framework of the SENTAD COVID clinical trial at the Abu Dhabi Stem Cells Center, were the patients received a nebulization therapy with the use of autologous stem cells (group A). Those patients were compared with a not stem cells treated control arm (group B), and both received the UAE COVID 19 standard management. An analysis of the culture samples, antimicrobial agents and the efficacy of the therapy on patient’s outcomes was done.

Results

A significant difference between the groups was found in the UTI incidence (p=*0.0206). Patients in group A showed a lower tendency to sepsis in comparison with group B (7% vs 21%), HR=0.35, (95% Confidence Interval: 0.13 – 0.91), p=0.0175. It was calculated a NNT=7.3. Candida albicans was the most frequently agent causing sepsis and UTI. The massive use of broad-spectrum antimicrobials was striking.

Conclusions

We found a protective factor of stem cells against secondary infection in COVID 19 cases, in terms of sepsis and UTI. The suggested immunomodulatory effect of stem cells offers a therapeutic strategy to manage the disease and avoid several complications. Antimicrobial agents can lead to increased opportunistic infections, so a rational approach to these treatments must be considered.

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  1. ScreenIT

    SciScore for 10.1101/2020.12.05.20244483: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: The exclusion criteria were: Patients with diagnosis of any kind of shock, organ transplants in the past 3 months, patients receiving immunosuppressive therapy, diagnostic of Hepatitis B Virus (HBV) infection or Human Immunodeficiency Virus (HIV) infection or Acquired Immunodeficiency Syndrome (AIDS), current diagnosis of cancer or history of malignancies in the past 5 years, pregnant or lactating women, patients who had participated in other clinical trials in the past 3 months, inability to comply with test requirements and blood collection or inability to provide informed consent.
    IRB: Ethics: The study was approved by the Emirates Institutional Review Board for COVID-19 Research (Ref. ID: DOH/CVDC/2020/1172).
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variableThe exclusion criteria were: Patients with diagnosis of any kind of shock, organ transplants in the past 3 months, patients receiving immunosuppressive therapy, diagnostic of Hepatitis B Virus (HBV) infection or Human Immunodeficiency Virus (HIV) infection or Acquired Immunodeficiency Syndrome (AIDS), current diagnosis of cancer or history of malignancies in the past 5 years, pregnant or lactating women, patients who had participated in other clinical trials in the past 3 months, inability to comply with test requirements and blood collection or inability to provide informed consent.

    Table 2: Resources

    No key resources detected.

    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:
    There are some limitations to the current study. It was carried in 4 different hospitals, each one with different criteria for taking cultures, as well the selection of the initial empiric antimicrobials treatment, can cause multiple germ resistant and negativization of some of the samples. It is our responsability for implementing and developing actions to control or stop the disease, but also change dangerous practices, through appropriate and consensual use of antimicrobials.

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

    IdentifierStatusTitle
    NCT04473170CompletedStudy Evaluating the Safety and Efficacy of Autologous Non-H…

    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 10.1101/2020.12.05.20244483v1 on medRxiv