Clinical presentation and evolution of COVID-19 in immunosuppressed patients. Preliminary evaluation in a North Italian cohort on calcineurin-inhibitors based therapy

  1. Lorenzo Cavagna
  2. Raffaele Bruno
  3. Giovanni Zanframundo
  4. Marilena Gregorini
  5. Elena Seminari
  6. Angela Di Matteo
  7. Teresa Rampino
  8. Carlomaurizio Montecucco
  9. Stefano Pelenghi
  10. Barbara Cattadori
  11. Eleonora Francesca Pattonieri
  12. Patrizio Vitulo
  13. Alessandro Bertani
  14. Gianluca Sambataro
  15. Carlo Vancheri
  16. Valentina Bonetto
  17. Maria Cristina Monti
  18. Elena Ticozzelli
  19. Annalisa Turco
  20. Tiberio Oggionni
  21. Angelo Corsico
  22. Veronica Codullo
  23. Monica Morosini
  24. Massimiliano Gnecchi
  25. Carlo Pellegrini
  26. Federica Meloni

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Abstract

The clinical course of COVID-19 in patients undergoing chronic immunosuppressive therapy is yet poorly known. We performed a monocentric cross-sectional study describing the clinical course of COVID-19 in a cohort of patients from northern Italy treated with calcineurin-inhibitors for organ transplantation or rheumatic diseases. Data were collected by phone call and clinical chart review between March 27 th - 31 st 2020. COVID-19 related symptoms, rynopharingeal swab, therapeutic changes and outcome were assessed in 384 consecutive patients (57% males; median age 61 years, IQR 48-69). 331 patients (86%) received solid organ transplantation (kidney n=140, 36%, heart n=100, 26%, lung n=91, 24%) and 53 (14%) had a rheumatic disease. Calcineurin inhibitors were the only immunosuppressant administered in 46 patients (12%). 14 patients developed a “confirmed COVID-19” (swab positivity) and 14 a “clinical COVID-19” (only typical symptoms). Fever (75%) and diarrhoea (50%) were the most common symptoms. Fourteen patients were hospitalized and 11 have already been dismissed. No patient required start/changes of the O2 therapy or developed superinfection. Only one patient, with metastatic lung cancer, died. In conclusion, COVID-19 showed a mild course in our cohort, with low mortality. Calcineurin inhibitor-based immunosuppressive regimens appear safe in this context and should not be discontinued.

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    SciScore for 10.1101/2020.04.26.20080663: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: All patients agreed to participate in this interview and provided the informed consent as approved by our IRB.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    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:
    Our study has some limitations. First, a short temporal window was considered, limiting the number of possible events recorded. Indeed, we cannot exclude that some of the contacted asymptomatic patients could develop the disease in the next days or weeks or that some of the patients could worsen or die subsequently. Second, we assessed most patients only by a phone-call, without a direct visit due to the established quarantine and only a few patients had recent blood tests available, which probably resulted in missing some asymptomatic cases. Third, the definition of clinical COVID19 may be matter of discussion. However, the substantial lack of patients with similar characteristic in the control group is surely a factor that strengthen our choice to add this class of patients in the analysis. Fourth, the control group was not completely comparable to the study group, since it included only patients with RMDs or lung transplantation. Nevertheless, we believe that this limit doesn’t really affect our results, since treatments regimen are comparable for all transplanted patients. Fifth, we could not find a completely equal control group of not immunosuppressed patients for both confirmed and clinical COVID-19 and for both outpatients and inpatients. Indeed, during the period of our observation, no immunosuppressed COVID-19 patients had generally been admitted to our Hospital with a more compromised respiratory picture compared to our cohort. The reason is that all admitted patie...

    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

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  2. Version published to 10.1101/2020.04.26.20080663v1 on medRxiv