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

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Retrospective cohort study of 2,541 hospitalized COVID-19 patients in Michigan showed a 66% and 71% hazard ratio reduction for hydroxychloroquine alone and hydroxychloroquine with azithromycin, respectively, compared to standard therapy.
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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.
  
This was one of the largest single hospital system studies in the US to show a significant mortality benefit for hydroxychloroquine in COVID-19 patients.
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Of note, this study relied on diagnosis of COVID-19 based on constellation of symptoms instead of PCR or serology testing.
  
The study has been challenged based on the usual limitations of retrospective studies as well as a potential difference in treatment goals between the standard therapy and treatment groups. Considering that the standard therapy group had significantly fewer events of intubation or admission to ICU, researchers suspect that a percentage of standard therapy patients may have been palliative with a treatment goal of comfort as opposed to recovery.
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This study was never formally published due to discrepancies between study protocol and approval by the ethics review board.
  
 
== Major Issues ==
 
== Major Issues ==
  
The standard therapy group had low rates of ventilation and admission to ICU compared to the hydroxychloroquine treatment groups. Interestingly, despite 108 deaths in the standard therapy group, only 34 and 62 patients received mechanical ventilation or admission to the ICU, respectively. This is surprising as deteriorating patients are often admitted to the ICU or ventilated prior to death. On the other hand, both hydroxychloroquine alone and hydroxychloroquine with azithromycin treatment groups had greater occurrences of ventilation and admission to ICU than the number of deaths. Researchers point to this finding as evidence that patients receiving standard therapy were more likely to be treated with palliative intent where advanced procedures (e.g. ventilation) or novel therapeutics (e.g. hydroxychloroquine) were not utilized.
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This study relied on telemedicine for outpatient diagnosis and management of patients. The drawbacks to this are decreased quality of physical exam and lack of PCR or serology testing for COVID-19. Both likely reduce the sensitivity and specificity of a COVID-19 diagnosis.   
 
 
If a greater percent of standard therapy patients were indeed palliative compared to the other treatment groups, this would be a significant confounding variable that is not addressed in the study.
 
 
 
A significantly greater number of patients treated with hydroxychloroquine also received steroid therapy compared to the standard therapy group (p<0.001). One of the outcomes of the RECOVERY study was the significant mortality benefit to steroid treatment in hospitalized COVID-19 patients. However, it is important to note that the RECOVERY trial only showed a 35% and 20% benefit in patients who were either ventilated or on respiratory support at the time of randomization. There was no benefit in patients who did not require respiratory support. It is unlikely that steroids could account for the entire mortality difference between the hydroxychloroquine and standard therapy groups, however, it may demonstrate a greater benefit for hydroxychloroquine than actually exists.   
 
  
 
== Minor Issues ==
 
== Minor Issues ==
  
No minor issues identified at this time.
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The study design in its final form did not receive approval by the responsible ethics review board.  
  
 
== Impact ==
 
== Impact ==
  
This study was one of the first to show a mortality benefit for hydroxychloroquine in a relatively large cohort of US COVID-19 patients.
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This was one of the first studies assessing efficacy of hydroxychloroquine and azithromycin in early, outpatient treatment of COVID-19.
  
 
== Article Revisions ==
 
== Article Revisions ==

Revision as of 03:08, 22 July 2020

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

This study relied on telemedicine for outpatient diagnosis and management of patients. The drawbacks to this are decreased quality of physical exam and lack of PCR or serology testing for COVID-19. Both likely reduce the sensitivity and specificity of a COVID-19 diagnosis.

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