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NHLBI Trial Concludes No Benefit for Hydroxychloroquine in COVID-19

No clinical benefit found for hydroxychloroquine versus placebo in hospitalized adults with COVID-19

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THURSDAY, Nov. 12, 2020 (HealthDay News) -- Hydroxychloroquine is not beneficial for adults hospitalized with COVID-19, according to the formal conclusion of a study funded by the U.S. National Heart, Lung, and Blood Institute (NHLBI) and published online Nov. 9 in the Journal of the American Medical Association.

Wesley H. Self, M.D., M.P.H., from the Vanderbilt University Medical Center in Nashville, Tennessee, and colleagues examined whether hydroxychloroquine is efficacious for adults hospitalized with COVID-19 in a multicenter, randomized trial conducted at 34 U.S. hospitals. Patients were randomly assigned to either hydroxychloroquine or placebo (242 and 237 patients, respectively); the trial was stopped for futility at the fourth interim analysis.

Of the patients, 90.4 percent completed the primary outcome assessment at 14 days. The researchers found that at 14 days, clinical status on the ordinal outcome scale did not differ significantly between the hydroxychloroquine and placebo groups (median, 6 versus 6; adjusted odds ratio, 1.02; 95 percent confidence interval, 0.73 to 1.42). There was no significant between-group difference in any of 12 secondary outcomes. At 28 days after randomization, 10.4 and 10.6 percent of patients in the hydroxychloroquine and placebo groups, respectively, had died (absolute difference, −0.2 percent [95 percent confidence interval, −5.7 to 5.3 percent]; adjusted odds ratio, 1.07 [95 percent confidence interval, 0.54 to 2.09]).

"Having a rigorously designed clinical trial that captured patient-centered, clinically meaningful outcomes was critical to reaching the unequivocal conclusions about the use of hydroxychloroquine in COVID-19. ORCHID [Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among Inpatients With Symptomatic Disease] shows that hydroxychloroquine does not improve clinical outcomes in hospitalized COVID-19 patients," James P. Kiley, Ph.D., director of the division of lung diseases at NHLBI, said in a statement.

Several authors disclosed financial ties to the biopharmaceutical industry.

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