“ Author Information ”“
An event is serious (based on the ICH definition) when the patient outcome is:”
* congenital anomaly
* other medically important event
In a study, a patient [age and sex not stated] was described, who developed prolongation of the QT interval during treatment with azithromycin and hydroxychloroquine for COVID-19 infection. The patient, who had severe COVID-19 infection, started receiving hydroxychloroquine and azithromycin [routes and dosages not stated]. After four days, the therapy was stopped due to prolongation of the QT interval from 405ms before treatment to 460 and 470ms under the combination [time to reaction onset and outcome not stated].
Molina JM, et al. No evidence of rapid antiviral clearance or clinical benefit with the combination of hydroxychloroquine and azithromycin in patients with severe COVID-19 infection. Medecine et Maladies Infectieuses 50: 384, No. 4, Jun 2020. Available from: URL: http://doi.org/10.1016/j.medmal.2020.03.006