In this episode, I’ll discuss a new observation study on hydroxychloroquine and Covid-19.
Article
Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19
Lead author: Joshua Geleris
Published in New England Journal of Medicine May 2020
Background
Following reports from China and South Korea, and then a small French cohort of patients, hydroxychloroquine has been widely used to treat patients with Covid-19. Unfortunately beyond these small reports and in vitro data, little information exists on this topic. With the availability of hydroxychloroquine from the strategic national stockpile, the authors of this study report their observations on its use in order to add to the available data in this area.
Methods
The authors evaluated a consecutive sample of patients admitted to a single medical center in New York City with Covid-19. The goal was to examine the association between treatment with hydroxychloroquine and intubation or death in patients with Covid-19. Patients who were intubated, died, or discharged within 24 hours after presentation to the emergency department were excluded from the analysis. The primary end point was a composite of intubation or death in a time-to-event analysis. A multivariable Cox model with inverse probability weighting according to the propensity score was used to account for baseline differences between groups.
Results
Out of 1446 consecutive patients, 70 patients were excluded from the analysis. The remaining 1376 patients, had a median follow-up of 22.5 days. Nearly 60% received hydroxychloroquine. The regimen used was 600 mg twice on day 1, then 400 mg daily for a median of 5 days.
Treatment did not begin immediately with 45.8% of the patients being treated within 24 hours after presentation to the ED, and 85.9% being treated within 48 hours. The patients in the hydroxychloroquine-treated group were sicker at baseline as measured by the median ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen of 223 vs. 360 in the group who did not receive hydroxychloroquine.
While there were more deaths in the hydroxychloroquine group in the crude analysis, After adjustment, the authors found there was no significant association between hydroxychloroquine use and intubation or death.
Conclusion
The authors concluded:
In this observational study involving patients with Covid-19 who had been admitted to the hospital, hydroxychloroquine administration was not associated with either a greatly lowered or an increased risk of the composite end point of intubation or death. Randomized, controlled trials of hydroxychloroquine in patients with Covid-19 are needed.
Discussion
In response to these results, the authors have changed clinical guidance at their center to remove the suggestion that patients with Covid-19 be treated with hydroxychloroquine unless in the context of a clinical trial. This opinion, to only use hydroxychloroquine in the context of a clinical trial is mirrored by the recent IDSA treatment guidelines for Covid-19. In contrast, the NIH guidelines do not put the stipulation of needing a clinical trial on the use of hydroxychloroquine, and the SCCM guidelines do not mention the use of hydroxychloroquine at all.
It is likely that not all clinicians will come to the same conclusion about only using hydroxychloroquine within the context of a clinical trial. Reasons for this include the relatively slow start of hydroxychloroquine in this study favoring the group that did not receive hydroxychloroquine, and the difficultly of enrolling patients in a clinical trial vs the feeling of needing to “do something” before the results of a randomized trial are available.
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