Renal Involvement in Patients with COVID-19 Pneumonia and Outcomes After Stem Cell Nebulization

  1. Gina M. Torres Zambrano
  2. Carlos A. Villegas Valverde
  3. Antonio Bencomo Hernández
  4. Lobna Abdel Hadi
  5. Rene Antonio Rivero
  6. Yendry Ventura Carmenate

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Abstract

Background

The COVID-19 pandemic presented an unprecedented challenge to identify effective drugs for prevention and treatment.

Objective

To characterize acute renal injury (AKI) in patients with COVID-19 and their relation with clinical outcomes within the framework of the SENTAD COVID clinical trial at the Abu Dhabi Stem Cells Center.

Methods

Abu Dhabi Stem Cell Center (ADSCC) proposed a prospective clinical trial nebulization treatment with autologous stem cells (Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC)), at Abu Dhabi hospitals.

Participants

20 treated patients were compared with 23 not treated patients. Both groups received COVID 19 standard treatment.

Outcomes

After the results were collected, this study was created to determine the impact of the disease on the renal function and the efficacy of the therapy on patient’s outcomes.

Results

One third of the critical patients studied suffered kidney failure. Patients in the treated group showed a favorable tendency to improve in contrast to those in the control group. Less patients from group A suffered from sepsis in comparison with the group B (25% vs 65%), HR=0.38, (95% Confidence Interval: 0.16 – 0.86), *p=0.0212. These results suggested a NNT=2.5. An improvement in lymphocyte count, CRP, and shorter hospital stay after treatment was evidenced, which led to less superinfection and sepsis in the treated group.

Conclusions

The proposed anti-inflammatory effect of the stem cells, offers a great promise for managing the illness, emerging as a crucial adjuvant tool in promoting healing and early recovery in severe COVID-19 infections and other supportive treatments.

ARTICLE SUMMARY

Our study had several strengths and limitation:

  • It was a randomized trial.

  • The treatment showed a positive result, providing evidence that this intervention is effective in routine practice.

  • We found fewer complications related to prolonged hospital stay in the treated group.

  • The is the small number of participants.

  • It was carried out in 4 different hospitals, each with different criteria for the selection of the initial empirical antimicrobials, which can cause multiple resistant germs.

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  1. ScreenIT

    SciScore for 10.1101/2020.12.16.20236877: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: The Exclusion criteria is as follows: Pediatric patients (aged < 18 years), 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.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variableThe Exclusion criteria is as follows: Pediatric patients (aged < 18 years), 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: 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: 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 10.1101/2020.12.16.20236877v1 on medRxiv