Hydroxychloroquine not effective for mild to moderate COVID-19, study shows
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Hydroxychloroquine, by itself or with azithromycin, did not improve the clinical status of patients with mild to moderate COVID-19, according to results from a randomized controlled trial published in The New England Journal of Medicine.
The trial was conducted at 55 hospitals in Brazil, where hydroxychloroquine has been formally recommended as a treatment for COVID-19 since March, according to Alexandre B. Cavalcanti, MD, PhD, of the Research Institute at the Hospital do Coração in São Paulo, and colleagues.
In the United States, prescriptions for hydroxychloroquine and azithromycin skyrocketed in the early days of the pandemic amid a debate about its effectiveness and safety. The FDA rescinded an emergency use authorization for the drug for COVID-19 patients on June 15 out of caution because “the known and potential benefits of chloroquine and hydroxychloroquine no longer outweighed the known and potential risks for the authorized use.”
Cavalcanti and colleagues conducted a multicenter, randomized, open-label, controlled trial among three groups of hospitalized patients with suspected or confirmed COVID-19 who were receiving either no supplemental oxygen or low amounts of supplemental oxygen.
According to the study, the researchers assigned patients in a 1:1:1 ratio to receive standard of care — which was “at the discretion of the treating physicians,” the authors explained — standard of care plus hydroxychloroquine twice daily or standard of care plus hydroxychloroquine twice daily and azithromycin once daily for 7 days. The researchers assessed patients’ clinical status at 15 days using a seven-level ordinal scale.
Overall, they included 667 patients in the study, including 504 with confirmed cases of COVID-19 who were included in the intent-to-treat analysis.
Compared with standard of care, the odds of a higher score on the ordinal scale at 15 days — which would indicate a worse condition — were not impacted by hydroxychloroquine alone (OR = 1.21; 95% CI, 0.69-2.11) or hydroxychloroquine with azithromycin (OR = 0.99; 95% CI, 0.57-1.73).
Moreover, “Patients who received hydroxychloroquine, either with azithromycin or alone, had more frequent events of [corrected QT] interval prolongation and elevation of liver-enzyme levels than patients who did not receive either agent,” Cavalcanti and colleagues wrote.
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