COVID-19 in persons affected by Hansen’s disease in Brazil

  1. Patrícia D. Deps
  2. Taynah A. R. Repsold
  3. Claudio G. Salgado
  4. Raquel de Carvalho Bouth
  5. Selma Regina Penha Silva Cerqueira
  6. Marisa Simon Brezinscki
  7. Rebeca Ruppert Galarda Baptista Peixoto
  8. Jaison Antonio Barreto
  9. Andrea M. A. Fonseca
  10. Marlene L. S. Peixoto
  11. Seyna Ueno R. Mendes
  12. Rafael Pereira Rabelo Mendes
  13. Pedro Paulo dos Santos Oliveira
  14. Ciro Martins Gomes

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Abstract

Background

Hansen’s disease (HD) is endemic in Brazil, a country with the third highest number of COVID-19 cases in the world and the second highest number of COVID-19 deaths. COVID-19 in persons affected by HD has not been described at population level in this country.

Methods

We collated numbers of COVID-19 cases and deaths among patients who were receiving routine treatment for HD at six centres across Brazil (Belém, Bauru, Brasília, Vitória, Petrolina, Palmas) between 1 st March and 10 th December 2020.

Results

Of 1,333 HD patients receiving treatment, 70 (5.2%) reported having had COVID-19. Almost all patients (97% (1,296/1,333)) including all but one of the COVID-19 cases were receiving MDT comprising rifampicin (600mg once per month), dapsone (100mg daily), and clofazimine (50 mg daily plus 300 mg once per month). Four patients died, including a patient in their 30’s on MDT who had a severe type 2 HD reaction (erythema nodosum leprosum) and who was taking clofazimine 100mg daily.

Conclusions

We cannot determine from these preliminary data whether persons affected by Hansen’s disease have a higher or lower risk of COVID-19 and related mortality compared with the general population. We will continue to monitor the effects of COVID-19 in persons affected by and treated for HD and extend this to monitor SARS-CoV-2 vaccine effectiveness in this group of patients.

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  1. ScreenIT

    SciScore for 10.1101/2020.12.11.20247262: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: Ethical approval was obtained from the research ethics committee (Comitê de Ética em Pesquisa, CEP) of the Universidade Federal do Espírito Santo (UFES), certificate no. 40347520.5.0000.5060.
    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:
    Considering the acute evolution time and high case fatality of COVID-19, side effects from higher doses or prolonged treatment would not be a limitation if clofazimine proved to be effective in suppressing the virus. However, we have some doubts that data from this patient group can provide evidence regarding the potential effectiveness of clofazimine against COVID-19: Although clofazimine has few side effects and is rarely replaced, antibiotics (including minocycline, ofloxacin, doxycycline, clarithromycin, moxifloxacin) are indicated to replace MDT components in cases where side effects are sufficiently serious [14, 22], or in cases of treatment failure and resistance. Corticosteroids and thalidomide are recommended to control Hansen’s disease reactions, and vitamin D, bisphosphonates, and aspirin to reduce treatment-related damage [23]. Analgesics, nonsteroidal anti-inflammatories, antibiotics, metformin, proton-pump inhibitors, amitriptyline, gabapentin, simvastatin are also used during treatment of Hansen’s disease [23]. This polypharmacy would further confound any estimated effects of clofazimine. One clinical trial of oral clofazimine for COVID-19 has been registered, using oral clofazimine 100mg twice daily on day 1, then 100mg daily for 2 days, compared with the same regimen plus a 3-day course of interferon β-1b [NCT04465695]. To investigate the effectiveness of clofazimine against severity of SARS-CoV-2 infection, we think that a higher dose of clofazimine can be g...

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

    IdentifierStatusTitle
    NCT04465695RecruitingDual Therapy With Interferon Beta-1b and Clofazimine for COV…

    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.

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  2. Version published to 10.1101/2020.12.11.20247262v1 on medRxiv