Clinical Outcomes and Adverse Drug Events Identified in Patients Treated
with Hydroxychloroquine and Azithromycin
Abstract
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 COVID-19+ patients who received hydroxychloroquine plus
azithromycin over a 2 week period. 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 evaluated included mortality at day 28, ICU admission,
requirement for mechanical ventilation and incidence of adverse drug
events. Results Data from a total of 82 patients with laboratory
confirmed SARS-CoV-2 infection was evaluated. Clinical improvement was
seen in 26.8% of patients at Day 7. 31% of patients were admitted to
ICU, 16 (19.5%) underwent mechanical ventilation and Day 28 mortality
was 28%. Age over 70, history of cardiovascular disease and 3 or more
comorbidities were risk factors for mortality. The incidence of adverse
drug events was 42%. No patient experienced a Grade 4 or 5 toxicity.
Over a fifth of patients (23) had raised LFTs (65% had raised LFTs at
baseline), 11 patients experienced prolonged QT and 1 patient
experienced grade 1 hypoglycaemia. Treatment was stopped early in
6(7.3%) patients due to prolonged QT interval or LFT elevations.
Conclusion This descriptive study details the clinical outcomes of
COVID-19 positive patients treated with these agents and highlights the
importance of monitoring all repurposed agents for adverse drug events.