Empirical treatment with hydroxychloroquine and azithromycin for suspected cases of COVID-19 followed-up by telemedicine

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Publication
Title
Authors
  • Rodrigo Esper, MD PhD
  • Rafael da Silva, MD
  • Fernando Oikawa, MD PhD
  • ...
  • Eduardo Parrillo, MD
Journal Manuscript
Date April 15, 2020

A non-randomized, prospective study in Sao Paulo, Brazil of 636 symptomatic outpatients treated with hydroxychloroquine for 7 days and azithromycin for 5 days vs control group showed a significant decrease in need for hospitalization. Only 1.9% versus 5.4% of patients in the treatment group needed hospitalization compared to the control group (p < 0.001) with a number needed to treat (NNT) of 28.

Of note, this study relied on diagnosis of COVID-19 based on constellation of symptoms instead of PCR or serology testing.

This study was never formally published due to discrepancies between study protocol and approval by the ethics review board.

Major Issues

The study has been challenged because the treatment group was clinically sicker at baseline than the control group, with dyspnea reported in 22.1% vs 16% (p < 0.0001).

Lastly, inclusion criteria was based on flu-like symptoms as opposed to positive COVID-19 PCR testing.

Minor Issues

The study design in its final form did not receive approval by the responsible ethics review board.

Impact

This was one of the first studies assessing efficacy of hydroxychloroquine and azithromycin in early, outpatient treatment of COVID-19.

Article Revisions

None at this time.

References