CIGB-258 immunomodulatory peptide: a novel promising treatment for critical and severe COVID-19 patients

  1. R Venegas-Rodriguez
  2. R Santana-Sanchez
  3. R Peña-Ruiz
  4. M Bequet-Romero
  5. M Hernandez-Cedeño
  6. B Santiesteban-Licea
  7. A Garcia
  8. PR Aroche
  9. D Oliva-Perez
  10. LM Ortega-Gonzalez
  11. J E Baldomero
  12. LR Cruz
  13. G Guillén
  14. G Martinez-Donato
  15. MC Dominguez-Horta
  16. for the CIGB-258 Study Group

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Abstract

This study characterizes the first clinical application of CIGB-258 in COVID-19 patients. CIGB-258 is an immunoregulatory peptide, derived from the cellular heat shock protein 60 (HSP60). Sixteen patients with COVID-19 in serious (31%) or critical (69%) conditions were included in this study. All critically ill patients recovered from the respiratory distress condition. Two of these patients had a fatal outcome due to nosocomial infections.The five seriously ill patients considerably improved. C-reactive protein (CRP) and interleukin-6 (IL-6) levels significantly decreased during treatment. CIGB-258 seems to be an effective and safe treatment option in COVID-19 patients under cytokine storm.

TRIAL REGISTRATION: RPCEC00000313

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  1. ScreenIT

    SciScore for 10.1101/2020.05.27.20110601: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIACUC: Patients: Patients in the study were included from March 31 to April 22 2020 at the Luis Diaz Soto and Pedro Kouri Hospitals in Havana, Cuba. The Ethics and Scientific Committees of each study site and the Cuban Regulatory Authority (CECMED, http://www.cecmed.cu/) approved the protocol.
    Consent: Patients or their legal representatives signed the informed consent before using CIGB-258.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    CRP and IL-6 data were analyzed using GraphPad Prism version 7.05 (GraphPadSofware, San Diego California, USA).
    GraphPad Prism
    suggested: (GraphPad Prism, RRID:SCR_002798)

    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: 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 10.1101/2020.05.27.20110601 on medRxiv