Similar incidence of coronavirus disease 2019 (COVID-19) in patients with rheumatic diseases with and without hydroxychloroquine therapy

  1. Juan Macías
  2. Paz González-Moreno
  3. Esther Sánchez-García
  4. Ramón Morillo-Verdugo
  5. José J. Pérez-Venegas
  6. Ana Pinilla
  7. MªMar Macho
  8. MªVictoria Martínez
  9. Alejandro González-Serna
  10. Anaïs Corma
  11. Luis M. Real
  12. Juan A. Pineda

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Abstract

Hydroxychloroquine is not efficacious as post-exposure prophylaxis against coronavirus disease 2019 (COVID-19). It is not known whether as pre-exposure prophylaxis it may prevent COVID-19.

Objective

To compare the incidence of COVID-19 in Spanish patients with autoimmune rheumatic diseases treated with and without hydroxychloroquine.

Patients and methods

Retrospective electronic record review, from February 27 th to June 21 st , 2020, of patients with autoimmune inflammatory diseases followed at two academic tertiary care hospitals in Seville, Spain. The cumulative incidence of confirmed COVID-19, by PCR or serology, was compared between patients with and without hydroxychloroquine as part of their treatment of autoimmune inflammatory diseases.

Results

Among 722 included patients, 290 (40%) were receiving hydroxychloroquine. During the seventeen-week study period, 10 (3.4% [95% CI: 1.7%-6.7%] cases of COVID-19 were registered among patients with hydroxychloroquine and 13 (3.0% [1.6%-5.1%]) (p = 0.565) in those without hydroxychloroquine. COVID-19 was diagnosed by PCR in four (1.4%, 95% CI 0.38%-3.5%) subject with hydroxychloroquine and six (1.4%, 95% CI 0.5%-3.0%) without hydroxychloroquine (p = 0.697). Three patients on hydroxychloroquine and four patients without hydroxychloroquine were admitted to the hospital, none of them required to be transferred to the intensive care unit and no patient died during the episode.

Conclusions

The incidence and severity of COVID-19 among patients with autoimmune rheumatic diseases with and without hydroxychloroquine was not significantly different.

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  1. Version published to 10.1371/journal.pone.0249036
  2. ScreenIT

    SciScore for 10.1101/2020.05.16.20104141: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: The study was approved by the Ethic Committee of the Valme University Hospital.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Statistical analyses were conducted using the package STATA 16.0 StataCorp, College Station, TX, USA.
    STATA
    suggested: (Stata, RRID:SCR_012763)
    StataCorp
    suggested: (Stata, RRID:SCR_012763)

    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:
    This study has a few limitations. First, most cases were possible or likely COVID-19 cases, but shortage of diagnostic kits and health care system collapse in Spain and other countries have led to the fact than many cases of COVID-19 were not able to be confirmed. In addition, data come only from hospital registers and mild cases could have been seen only in primary care; likewise, most asymptomatic cases would have gone unnoticed. However, even having omitted patients, these data show that incidence of COVID-19 in subjects treated with HCQ would be far from zero. Therefore, HCQ would not be an ideal therapy for post-exposure prophylaxis of SARS-CoV-2 infection. In summary, although the definitive information on the effectiveness of HCQ in post-exposure prophylaxis against SARS-CoV-2 infection will eventually come from controlled clinical trials, according to these results, other strategies should be designed to be tested, since HCQ monotherapy, as the best, does not protect against a significant number of infections with this coronavirus.

    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.

  3. Version published to 10.1101/2020.05.16.20104141v1 on medRxiv