medwireNews: Treatment with hydroxychloroquine does not reduce 28-day mortality risk among patients hospitalized with COVID-19, show results from the large-scale UK-based RECOVERY trial.
The 28-day mortality rate was 27.0% among 1561 patients randomly assigned to receive hydroxychloroquine sulfate 200 mg in a loading dose of four tablets (total dose, 800 mg) at baseline and 6 hours, followed by two tablets at 12 hours and then every 12 hours for 9 days or until discharge, whichever occurred earlier.
By comparison, the rate was 25.0% among the 3155 patients randomly assigned to receive usual care, report Peter Horby (University of Oxford) and colleagues in The New England Journal of Medicine.
The trial, which is being conducted at 176 UK hospitals, enrolled patients between 25 March and 5 June 2020. At randomization, 17% were receiving invasive mechanical ventilation, 60% were receiving oxygen only (with or without noninvasive ventilation), and 24% were receiving neither.
Subgroup analyses, by age, sex, race or ethnicity, duration of symptoms, type of respiratory support at baseline, and baseline-predicted risk, showed similar results.
The researchers also found that patients who received hydroxychloroquine spent longer in hospital than those who received usual care (median 16 vs 13 days) and were less likely to be discharged from hospital alive within 28 days (59.6 vs 62.9%).
Furthermore, individuals who were not undergoing mechanical ventilation at baseline had a higher rate of invasive mechanical ventilation or death if they were treated with hydroxychloroquine relative to usual care (30.7 vs 26.9%).
Horby and team note that the rate of cardiovascular death was slightly higher (by 0.4 percentage points) in the hydroxychloroquine group, but there was no difference versus usual care in the incidence of supraventricular tachycardia, ventricular tachycardia or fibrillation, or atrioventricular block requiring intervention.
There was, however, one case of torsades de pointes that the researchers deemed to be related to hydroxychloroquine, from which the patient recovered without intervention.
Horby and team note that, on 5 June 5 2020, enrollment to the hydroxychloroquine group was stopped, after an interim analysis determined that there was a lack of efficacy. Patients already receiving hydroxychloroquine as part of the trial discontinued the agent at this point.
The investigators conclude that “hydroxychloroquine was not an effective treatment for patients hospitalized with Covid-19.”
They add: “The WHO has released preliminary results from the SOLIDARITY trial on the effectiveness of hydroxychloroquine in hospitalized patients with Covid-19 that are consistent with the results from the RECOVERY trial.”
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N Engl J Med 2020; doi:10.1056/NEJMoa2022926