Hydroxychloroquine / azithromycinStudy Calls into Question Use of Malaria Drug for COVID-19
A retrospective study of patients with COVID-19 found no evidence that the anti-malaria drug hydroxychloroquine, either with or without the antibiotic azithromycin, reduced mortality or the need for mechanical ventilation. Researchers also found that hydroxychloroquine alone was associated with increased mortality. Early excitement about the combination was based on a small French study, and President Donald Trump soon began touting the combination as a potential “game changer,” but the findings from the study, which is the largest to date to report on outcomes from treating COVID-19 patients with the anti-malaria drug and uses a database that has been used for many different studies, suggest that the hydroxychloroquine/azithromycin combination may not be as promising for treating COVID-19 as some have hoped.
A retrospective study of patients with COVID-19 at Veterans Affairs (VA) hospitals found no evidence that the anti-malaria drug hydroxychloroquine, either with or without the antibiotic azithromycin, reduced mortality or the need for mechanical ventilation.
Researchers also found that hydroxychloroquine alone was associated with increased mortality.
The findings, published this week on the preprint server medRxiv, suggest hydroxychloroquine may not have as much promise for treating COVID-19 patients as initially hoped. The study was not a randomized controlled trial, so the implications of the findings are limited, and the results have not been peer-reviewed. Still, the authors say the results suggest clinicians need to be careful about using the drug in COVID-19 patients.
“Data from ongoing, randomized controlled studies will prove informative when they emerge,” they wrote. “Until then, the findings from this retrospective study suggest caution in using hydroxychloroquine in hospitalized COVID-19 patients, particularly when not combined with azithromycin.”
No Benefit Found
For the study, researchers with Columbia VA Health Care System, the University of South Carolina, and the University of Virginia School of Medicine looked at data from 368 VA patients with confirmed COVID-19 treated from 9 March until 11 April.
The patients were assigned to one of three cohorts based on medication exposure: patients treated with hydroxychloroquine alone (97), patients treated with hydroxychloroquine and azithromycin (113), and patients who did not receive hydroxychloroquine (158). The two primary outcomes were death and the need for mechanical ventilation.
Overall, there were 27 deaths (27.8 percent) in the hydroxychloroquine group, 25 deaths (22.1 percent) in the hydroxychloroquine/azithromycin group, and 18 deaths (11.4 percent) in the group that did not receive hydroxychloroquine. Mechanical ventilation occurred in 13.3 percent of the hydroxychloroquine patients, 6.9 percent of the hydroxychloroquine/azithromycin patients, and 14.1 percent of the no-hydroxychloroquine group.
Multilevel statistical analysis of the outcomes showed that, compared with the group that did not receive hydroxychloroquine, the risk of death from any cause was more than two-and-a-half times higher in the hydroxychloroquine patients (adjusted hazard ratio [HR], 2.61; 95 percent confidence interval [CI], 1.10 to 6.17; P = 0.03), but was not significantly higher in the hydroxychloroquine/azithromycin patients (adjusted HR, 1.14; 95 percent CI, 0.56 to 2.32; P = 0.72).
The researchers observed no difference in the risk of ventilation in either the hydroxychloroquine group (adjusted HR, 1.43; 95 percent CI, 0.53 to 3.79; P = 0.48) or the hydroxychloroquine/ azithromycin patients (adjusted HR, 0.43; 95 percent CI, 0.16 to 1.12; P = 0.09) compared with the no-hydroxychloroquine group.
