medwireNews: Findings from two randomized trials provide further evidence to suggest that hydroxychloroquine has no benefits for the prevention or treatment of COVID-19.
In the first, reported in The New England Journal of Medicine, 2314 asymptomatic contacts of 672 patients with polymerase chain reaction (PCR)-confirmed COVID-19 were randomly assigned to receive prophylactic hydroxychloroquine at a single dose of 800 mg followed by 400 mg/day for 6 days, or to receive no treatment. All participants received a COVID-19 test at baseline and 14 days later.
Oriol Mitjà (Hospital Germans Trias i Pujol, Barcelona, Spain) and co-investigators from the BCN-PEP-CoV2 Research Group report that rates of symptomatic confirmed SARS-CoV-2 infection at day 14 were comparable among the 1116 contacts given hydroxychloroquine and the 1198 in the control arm, at 5.7% and 6.2%, respectively.
In all, 314 participants tested positive for SARS-CoV-2 at baseline. These people had higher rates of symptomatic confirmed COVID-19 at week 14 than those with a negative test, but the incidence rates were comparable in the hydroxychloroquine and control arms irrespective of whether they tested positive (22.2 vs 18.6%) or negative (3.0 vs 4.3%) at baseline.
Together, these findings show that hydroxychloroquine has “no efficacy as prophylactic therapy for contacts who [are] PCR-negative at baseline,” as well as “no apparent efficacy as early preemptive therapy” to prevent progression from asymptomatic infection to symptomatic disease among contacts testing positive, say the researchers.
In the second study, Wesley Self (Vanderbilt University Medical Center, Nashville, Tennessee, USA) and team evaluated the efficacy of hydroxychloroquine as a treatment option in hospitalized adult patients with COVID-19.
As reported in JAMA, clinical status on a scale ranging from 1 (death) to 7 (discharged and able to perform normal activities) at 14 days was not significantly different among the 242 participants randomly assigned to receive hydroxychloroquine and the 237 given placebo, with a median score of 6 points in both groups. Hydroxychloroquine was given at a dose of 400 mg twice daily on day 1, followed by 200 mg twice daily on days 2–5.
Hydroxychloroquine “did not improve or worsen clinical outcomes,” and “[t]hese findings were consistent in all subgroups and for all outcomes evaluated, including an ordinal scale of clinical status, mortality, organ failures, duration of oxygen use, and hospital length of stay,” say Self and colleagues.
Interpreted alongside previous study findings, “the results of this trial provide strong evidence that hydroxychloroquine is not beneficial for adults hospitalized with COVID-19,” they conclude.
medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2020 Springer Healthcare Ltd, part of the Springer Nature Group
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N Engl J Med 2020; doi:10.1056/NEJMoa2021801
JAMA 2020; doi:10.1001/jama.2020.22240