Br J Clin Pharmacol. 2020 Jul 20. doi: 10.1111/bcp.14482. Online ahead of print.
AIM: To assess clinical outcomes and adverse drug events in patients hospitalised with COVID -19 treated with off- label hydroxychloroquine and azithromycin.
METHODS: We performed a retrospective analysis of hospitalised patients that had a positive polymerase chain reaction (PCR) test for SARS-CoV-2 and received hydroxychloroquine plus azithromycin (HCQ/Az) or no targeted therapy. The primary end point was clinical improvement on day 7 defined as either hospital discharge or an improvement of two points on a six-category ordinal scale. Secondary outcomes included mortality at day 28, intensive care (ICU) admission, requirement for mechanical ventilation and incidence of adverse events (AEs).
RESULTS: Data from a total of 134 patients was evaluated, 82 patients received HCQ/Az and 52 patients received no targeted therapy. Clinical improvement was seen in 26.8% of patients who received HCQ/Az but this was not significant. The rates of ICU transfer and mechanical ventilation were higher in the treatment group, these differences were not significant. Mortality at day 28 was significantly higher in the treatment group (p 0.03). Hypoglycaemia elevated liver function tests (LFTs) and QT prolongation were monitored in both groups. The risk of QT prolongation was significantly higher in the treatment group. Treatment was stopped early in 6 (7.3%) patients due AEs.
CONCLUSION: Although patients who received HCQ/Az were more severely ill the administration of these repurposed drugs did not result in clinical improvement, and was associated with a significant increase in toxicity. This descriptive study highlights the importance of monitoring all repurposed agents for adverse events.